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NCT03067181 · CITED IN SOURCE DOCUMENTS

Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
RECRUITING
Registry last update
2026-08-25

This phase III trial studies how well active surveillance help doctors to monitor subjects with low risk germ cell tumors for recurrence after their tumor is removed. When the germ cell tumor has spread outside of the organ in which it developed, it is considered metastatic. Chemotherapy drugs, such as bleomycin, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The trial studies whether carboplatin or cisplatin is the preferred chemotherapy to use in treating metastatic standard risk germ cell tumors.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
Inclusion Criteria: * There is no age limit for the low risk stratum (stage I ovarian immature teratoma and stage I non-seminoma or seminoma malignant GCT \[all sites\]) * Standard risk 1: Patients must be \< 11 years of age at enrollment * Standard risk 2: Patients must be \>= 11 and \< 25 years of age at enrollment * Patients enrolling on one of the low risk arms must be newly diagnosed with a stage I germ cell tumor; for the standard risk arms, patients must be newly diagnosed with malignant germ cell tumor (stage II or higher). * Histologic confirmation of a primary extracranial germ cell tumor in any of the categories outlined below is required of all patients at enrollment , with the following exceptions: * Among patients were initially diagnosed with completely resected non-seminoma malignant GCT and later recur during observation post surgery, a diagnostic biopsy is not required for enrollment if elevated tumor markers rise to \> 5 x upper limit of normal (ULN) on at least 2 measurements taken at least 1 week apart. The pathology report of initial surgery should be provided * Patients may be enrolled without histologic or cytologic confirmation in the rare case where there are exceptionally raised tumor markers (alpha fetoprotein \[AFP- ≥ 500 ng/mL or HCG ≥ 500 IU/L) and radiologic features consistent with GCT. In addition, the treating clinician must deem that the patient's tumor is not suitable for upfront resection and that a biopsy is not in the patient's best interest; or that there is a need to start therapy urgently * Low risk immature teratoma (IT); site: ovarian; stage: any; grade: any; histology: pure immature teratoma, mixed immature and mature teratoma, (may contain microscopic foci of yolk sac tumor \[\< 3 mm\], but no other pathological evidence of MGCT); tumor markers: alpha-FP =\< 1,000 ng/mL, beta-HCG institutional normal; all ages * Low risk stage I non-seminoma MGCT; site: ovarian, testicular, or extragonadal; stage: COG stage I, FIGO stage IA and IB, American Joint Committee on Cancer (AJCC) testicular stage IA, IB and IS; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or mixed); all ages * Low risk stage I seminoma-MGCT; site: testicular; stage: COG stage I; AJCC testicular stage IA IB, and IS; histology: must contain only seminoma; may contain immature/mature teratoma; may NOT contain yolk sac tumor, embryonal carcinoma, or choriocarcinoma; all ages * Standard risk 1 (SR1); site: ovarian, testicular, or extragonadal; stage: COG stage II-IV, FIGO stage IC-IV, (International Germ Cell Consensus Classification \[IGCCC\] criteria DO NOT apply); histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) \< 11 * Standard risk 2 (SR2) * Site: ovarian; stage: COG stage II, III, and III-X, FIGO stage IC, II and III; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) \>= 11 and \< 25 * Site: testicular; stage: COG stage II-IV, AJCC stage II, III, IGCCC good risk; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma: must be IGCCC good risk; post op: alpha-FP \< 1,000 ng/mL, beta-HCG \< 5,000 IU/mL and lactate dehydrogenase (LDH) \< 3.0 x normal; age (years) \>= 11 and \< 25 * Notes: * IGCCC criteria only apply to SR2 patients with a testicular primary tumor * Use post-op tumor marker levels to determine IGCCC risk group * Pure seminoma patients are not eligible for the standard risk arms of the study * For the low risk stage I non-seminoma MGCT and the standard risk arms, components of yolk sac tumor, embryonal carcinoma, or choriocarcinoma can be mixed with other forms of GCT, such as seminoma or mature or immature teratoma; if yolk sac tumor is the only malignant component present, then it must be deemed by the pathologist to be greater than a "microscopic component" of yolk sac tumor * Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, 2 or 3; use Karnofsky for patients \> 16 years of age and Lansky for patients =\< 16 years of age * Organ function requirements apply ONLY to patients who will receive chemotherapy (SR1 and SR2 patients) * Adequate renal function defined as: * Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 (within 7 days prior to enrollment) OR * A serum creatinine based on age/sex as follows (within 7 days prior to enrollment): (mg/dL) * 1 month to \< 6 months male: 0.4 female: 0.4 * 6 months to \< 1 year male: 0.5 female: 0.5 * 1 to \< 2 years male: 0.6 female: 0.6 * 2 to \< 6 years male: 0.8 female: 0.8 * 6 to \< 10 years male: 1 female: 1 * 10 to \< 13 years male: 1.2 female: 1.2 * 13 to \< 16 years: male: 1.5 female: 1.4 * \>= 16 years male: 1.7 female: 1.4 * Total bilirubin =\< 2 x upper limit of normal (ULN) for age (within 7 days prior to enrollment) * Unless due to Gilbert's disease, malignant involvement of liver or vanishing bile duct syndrome * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3 x upper limit of normal (ULN) (within 7 days prior to enrollment) * Unless due to Gilbert's disease, malignant involvement of liver or vanishing bile duct syndrome * Peripheral absolute neutrophil count (ANC) \>= 750/mm\^3 (within 7 days prior to enrollment) AND * Platelet count \>= 75,000/mm\^3 (within 7 days prior to enrollment) * Patients enrolling on the standard risk arms must be medically fit to receive protocol treatment and with no contraindications to protocol treatment * Eligibility criteria to participate in the pilot study of the AYA-Hears instrument (patient reported outcomes \[PROs\] of ototoxicity) Note: participants in group 1 will not receive AGCT1531 protocol-directed therapy; all other AYA-HEARS patients must be enrolled on the AGCT1531 SR2 arm in order to participate * \>= 11 and \< 25 years old at enrollment * Able to fluently speak and read English * Has received prior cisplatin- or carboplatin-based chemotherapy regimen for malignancy including diagnoses other than germ cell tumor * Followed for cancer or survivorship care at one of the following institutions: * Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center * Dana Farber/Harvard Cancer Center * Hospital for Sick Children * Children's Hospital of Eastern Ontario * Oregon Health and Science University * Seattle Children's Hospital * Yale University Exclusion Criteria: * Patients with any diagnoses not listed including: * Stage I testicular cancer patients who have undergone primary RPLND (retroperitoneal lymph node dissection) * Pure ovarian or extragonadal dysgerminoma/seminoma * Pure mature teratoma * Pure immature teratoma with alpha-fetoprotein (AFP) \>= 1000 ng/mL * "Poor risk" GCT (age \>= 11 years old and COG stage IV ovarian, COG stage II- IV extragonadal, or IGCCC intermediate or poor risk testicular), or * Primary central nervous system (CNS) germ cell tumor * Germ cell tumor with somatic malignant transformation * Spermatocytic seminoma * Patients must have had no prior systemic therapy for the current cancer diagnosis * Patients must have had no prior radiation therapy with the exception of CNS irradiation of brain metastases; (this exception only applies to SR1 patients; any patients over age 11 with distant metastases to brain \[stage IV disease\] would be considered poor risk and therefore not eligible for this trial) * Patients with significant, pre-existing co-morbid respiratory disease that contraindicate the use of bleomycin are ineligible for the standard risk arms of the trial * Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs; a pregnancy test is required for female patients of childbearing potential; (this criteria applies ONLY to patients who will receive chemotherapy \[SR1 and SR2 patients\]) * Lactating females who plan to breastfeed their infants; (this criteria applies ONLY to patients who will receive chemotherapy \[SR1 and SR2 patients\]) * Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation; (this criteria applies ONLY to patients who will receive chemotherapy \[SR1 and SR2 patients\])
healthy Volunteers
false
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive bleomycin IV over 10 minutes and carboplatin IV over 1 hour on day 1. Patients also receive etoposide IV over 1-2 hours on days 1-5. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study.
    intervention Names
    1. Procedure: Biopsy Procedure
    2. Procedure: Biospecimen Collection
    3. Biological: Bleomycin Sulfate
    4. Drug: Carboplatin
    5. Procedure: Computed Tomography
    6. Drug: Etoposide
    7. Procedure: Magnetic Resonance Imaging
    8. Procedure: Pulmonary Function Test
    9. Other: Questionnaire Administration
    label
    Arm I (bleomycin, carboplatin, etoposide)
    type
    EXPERIMENTAL
  2. description
    Patients receive bleomycin IV over 10 minutes on day 1. Patients also receive etoposide IV over 1-2 hours and cisplatin IV over 1-3 hours on days 1-5. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study.
    intervention Names
    1. Procedure: Biopsy Procedure
    2. Procedure: Biospecimen Collection
    3. Biological: Bleomycin Sulfate
    4. Drug: Cisplatin
    5. Procedure: Computed Tomography
    6. Drug: Etoposide
    7. Procedure: Magnetic Resonance Imaging
    8. Procedure: Pulmonary Function Test
    9. Other: Questionnaire Administration
    label
    Arm II (bleomycin, etoposide, cisplatin)
    type
    EXPERIMENTAL
  3. description
    Patients receive bleomycin IV over 10 minutes on days 1, 8, and 15, etoposide IV over 1-2 hours on days 1-5, and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study.
    intervention Names
    1. Procedure: Biopsy Procedure
    2. Procedure: Biospecimen Collection
    3. Biological: Bleomycin Sulfate
    4. Drug: Carboplatin
    5. Procedure: Computed Tomography
    6. Drug: Etoposide
    7. Procedure: Magnetic Resonance Imaging
    8. Procedure: Pulmonary Function Test
    9. Other: Questionnaire Administration
    label
    Arm III (bleomycin, etoposide, carboplatin)
    type
    EXPERIMENTAL
  4. description
    Patients receive bleomycin IV over 10 minutes on days 1, 8, and 15, etoposide IV over 1-2 hours on days 1-5, and cisplatin IV over 1-3 hours on days 1-5. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study.
    intervention Names
    1. Procedure: Biopsy Procedure
    2. Procedure: Biospecimen Collection
    3. Biological: Bleomycin Sulfate
    4. Drug: Cisplatin
    5. Procedure: Computed Tomography
    6. Drug: Etoposide
    7. Procedure: Magnetic Resonance Imaging
    8. Procedure: Pulmonary Function Test
    9. Other: Questionnaire Administration
    label
    Arm IV (bleomycin, etoposide, cisplatin)
    type
    EXPERIMENTAL
  5. description
    Patients with low-risk stage I grade 2, 3 ovarian immature teratoma or stage I non-seminoma or seminoma MGCTs undergo observation and can transfer to standard risk arm when eligibility criteria are met. Patients with stage I seminoma testicular MGCT undergo observation, and those with residual/recurrent disease are treated at the discretion of their physician. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial.
    intervention Names
    1. Other: Best Practice
    2. Procedure: Biopsy Procedure
    3. Procedure: Biospecimen Collection
    4. Procedure: Computed Tomography
    5. Procedure: Magnetic Resonance Imaging
    6. Other: Questionnaire Administration
    label
    Low-Risk (observation)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Low-Risk (observation)
    description
    Undergo observation
    name
    Best Practice
    other Names
    1. standard of care
    2. standard therapy
    type
    OTHER
  2. arm Group Labels
    1. Arm I (bleomycin, carboplatin, etoposide)
    2. Arm II (bleomycin, etoposide, cisplatin)
    3. Arm III (bleomycin, etoposide, carboplatin)
    4. Arm IV (bleomycin, etoposide, cisplatin)
    5. Low-Risk (observation)
    description
    Undergo a tumor biopsy
    name
    Biopsy Procedure
    other Names
    1. Biopsy
    2. BIOPSY_TYPE
    3. Bx
    type
    PROCEDURE
  3. arm Group Labels
    1. Arm I (bleomycin, carboplatin, etoposide)
    2. Arm II (bleomycin, etoposide, cisplatin)
    3. Arm III (bleomycin, etoposide, carboplatin)
    4. Arm IV (bleomycin, etoposide, cisplatin)
    5. Low-Risk (observation)
    description
    Undergo blood sample collection
    name
    Biospecimen Collection
    other Names
    1. Biological Sample Collection
    2. Biospecimen Collected
    3. Specimen Collection
    type
    PROCEDURE
  4. arm Group Labels
    1. Arm I (bleomycin, carboplatin, etoposide)
    2. Arm II (bleomycin, etoposide, cisplatin)
    3. Arm III (bleomycin, etoposide, carboplatin)
    4. Arm IV (bleomycin, etoposide, cisplatin)
    description
    Given IV
    name
    Bleomycin Sulfate
    other Names
    1. Blanoxan
    2. BleMomycine
    3. Blenoxane
    4. Bleo-cell
    5. Bleo-S
    6. Bleocin
    7. Bleolem
    8. Bleomycin Sulfas
    9. Bleomycin Sulphate
    10. Bleomycini Sulfas
    11. Blexane
    12. Oil Bleo
    type
    BIOLOGICAL
  5. arm Group Labels
    1. Arm I (bleomycin, carboplatin, etoposide)
    2. Arm III (bleomycin, etoposide, carboplatin)
    description
    Given IV
    name
    Carboplatin
    other Names
    1. Blastocarb
    2. Carboplat
    3. Carboplatin Hexal
    4. Carboplatino
    5. Carboplatinum
    6. Carbosin
    7. Carbosol
    8. Carbotec
    9. CBDCA
    10. Displata
    11. Ercar
    12. JM-8
    type
    DRUG
  6. arm Group Labels
    1. Arm II (bleomycin, etoposide, cisplatin)
    2. Arm IV (bleomycin, etoposide, cisplatin)
    description
    Given IV
    name
    Cisplatin
    other Names
    1. Abiplatin
    2. Blastolem
    3. Briplatin
    4. CDDP
    5. Cis-diammine-dichloroplatinum
    6. Cis-diamminedichloridoplatinum
    7. Cis-diamminedichloro Platinum (II)
    8. Cis-diamminedichloroplatinum
    9. Cis-dichloroammine Platinum (II)
    10. Cis-platinous Diamine Dichloride
    11. Cis-platinum
    12. Cis-platinum II
    type
    DRUG
  7. arm Group Labels
    1. Arm I (bleomycin, carboplatin, etoposide)
    2. Arm II (bleomycin, etoposide, cisplatin)
    3. Arm III (bleomycin, etoposide, carboplatin)
    4. Arm IV (bleomycin, etoposide, cisplatin)
    5. Low-Risk (observation)
    description
    Undergo a CT scan
    name
    Computed Tomography
    other Names
    1. CAT
    2. CAT Scan
    3. Computed Axial Tomography
    4. Computerized Axial Tomography
    5. Computerized axial tomography (procedure)
    6. Computerized Tomography
    7. Computerized Tomography (CT) scan
    8. CT
    9. CT Scan
    10. Diagnostic CAT Scan
    11. Diagnostic CAT Scan Service Type
    12. tomography
    type
    PROCEDURE
  8. arm Group Labels
    1. Arm I (bleomycin, carboplatin, etoposide)
    2. Arm II (bleomycin, etoposide, cisplatin)
    3. Arm III (bleomycin, etoposide, carboplatin)
    4. Arm IV (bleomycin, etoposide, cisplatin)
    description
    Given IV
    name
    Etoposide
    other Names
    1. Demethyl Epipodophyllotoxin Ethylidine Glucoside
    2. EPEG
    3. Lastet
    4. Toposar
    5. Vepesid
    6. VP 16
    7. VP 16-213
    8. VP 16213
    9. VP-16
    10. VP-16-213
    11. VP-16213
    12. VP16
    type
    DRUG
  9. arm Group Labels
    1. Arm I (bleomycin, carboplatin, etoposide)
    2. Arm II (bleomycin, etoposide, cisplatin)
    3. Arm III (bleomycin, etoposide, carboplatin)
    4. Arm IV (bleomycin, etoposide, cisplatin)
    5. Low-Risk (observation)
    description
    Undergo MRI
    name
    Magnetic Resonance Imaging
    other Names
    1. Magnetic Resonance
    2. Magnetic Resonance Imaging (MRI)
    3. Magnetic resonance imaging (procedure)
    4. Magnetic Resonance Imaging Scan
    5. Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
    6. MR
    7. MR Imaging
    8. MRI
    9. MRI Scan
    10. MRIs
    11. NMR Imaging
    12. NMRI
    type
    PROCEDURE
  10. arm Group Labels
    1. Arm I (bleomycin, carboplatin, etoposide)
    2. Arm II (bleomycin, etoposide, cisplatin)
    3. Arm III (bleomycin, etoposide, carboplatin)
    4. Arm IV (bleomycin, etoposide, cisplatin)
    description
    Undergo a pulmonary function test
    name
    Pulmonary Function Test
    other Names
    1. lung function test
    2. PFT
    3. Pulmonary Function Testing
    4. Pulmonary Function Tests
    type
    PROCEDURE
  11. arm Group Labels
    1. Arm I (bleomycin, carboplatin, etoposide)
    2. Arm II (bleomycin, etoposide, cisplatin)
    3. Arm III (bleomycin, etoposide, carboplatin)
    4. Arm IV (bleomycin, etoposide, cisplatin)
    5. Low-Risk (observation)
    description
    Ancillary studies
    name
    Questionnaire Administration
    type
    OTHER
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
1780
type
ESTIMATED
Registered outcome plans (not posted results)
other Outcomes
  1. description
    Tumor marker decline is coded as yes versus no. The hazard ratio for participants with and without tumor marker decline will be presented. Patients who receive chemotherapy will be analyzed separately than patients in the low risk stratum.
    measure
    Event-free survival (EFS) for participants with and without tumor marker decline
    time Frame
    Up to 2 years
  2. description
    Self-reported peripheral neuropathy will be assessed using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity scale.
    measure
    Self-reported peripheral neuropathy score
    time Frame
    Up to 12 months after end of therapy
  3. description
    A patient will be considered to have residual tumor if the patient has a residual mass ≥ 1 cm at the completion of chemotherapy based on imaging reports.
    measure
    Presence of residual tumor
    time Frame
    Up to 12 months
  4. description
    miR-371a-3p will be measured from frozen serum to estimate the association with time-to-relapse as well as sensitivity, specificity, negative predictive value, and positive predictive value.
    measure
    Serum mir-371a-3p levels
    time Frame
    Within six weeks of surgery, at relapse (cases) or the time closest to the case's relapse (controls), and the timepoint immediately preceding the "relapse" timepoint, up to 2 years
primary Outcomes
  1. description
    The time from study entry to the date of death, or date of last contact and ascertained as alive, whichever comes first.
    measure
    Overall survival
    time Frame
    Two years post enrollment
  2. description
    The time from study entry to the date of death, date of disease progression or recurrence, date of second malignant neoplasm or date of last contact and ascertained as alive, whichever comes first.
    measure
    Event-free survival
    time Frame
    Two years post enrollment
secondary Outcomes
  1. description
    The hearing loss is evaluated according to the International Society of Pediatric Oncology criteria.
    measure
    Presence of hearing loss
    time Frame
    8 weeks after the last dose of platin therapy
  2. description
    AYA HEARs is a 9-item questionnaire with each question scored on a 5-point Likert scale (range = 0-4).
    measure
    Adolescents and Young Adults-Hearing Screen (AYA HEARs)
    time Frame
    Baseline, end of therapy, 2 months post-end of therapy, and 1 year after enrollment
  3. description
    Imaging and radiology reports will be analyzed using Slice-O-Matic software (Tomovision), and imaging results will be used to calculate whole-body lean body mass.
    measure
    Whole body lean body mass
    time Frame
    At diagnosis, at end of therapy, and up to 1 year after end of therapy
Full study description
brief Summary
This phase III trial studies how well active surveillance help doctors to monitor subjects with low risk germ cell tumors for recurrence after their tumor is removed. When the germ cell tumor has spread outside of the organ in which it developed, it is considered metastatic. Chemotherapy drugs, such as bleomycin, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The trial studies whether carboplatin or cisplatin is the preferred chemotherapy to use in treating metastatic standard risk germ cell tumors.
detailed Description
PRIMARY OBJECTIVES: I. To evaluate whether a strategy of complete surgical resection followed by surveillance can maintain an overall survival rate of at least 95.7% at two years for pediatric, adolescent and adult patients with stage I (low risk) malignant germ cell tumors (Stratum 2), and at least 88% for patients with all stage/grade ovarian pure immature teratoma (Stratum 1). II. To compare the event-free survival of a carboplatin versus (vs.) cisplatin-based regimen in the treatment of pediatric, adolescent and young adult patients with standard risk non-seminomatous germ cell tumors. IIa. To compare the event free survival (EFS) of a carboplatin-based regimen (carboplatin \[C\] etoposide \[E\] bleomycin \[b\]) vs. a cisplatin-based regimen (cisplatin \[P\]Eb) in children (less than 11 years in age) with standard risk germ cell tumors (GCT). IIb. To compare the EFS of a carboplatin-based regimen (BEC) vs. a cisplatin-based regimen (BEP) in adolescents and young adults (ages 11 - \< 25 years) with standard risk GCT. SECONDARY OBJECTIVES: I. To compare the incidence of ototoxicity in children, adolescents and young adults with standard risk germ cell tumors treated with carboplatin-based chemotherapy as compared to cisplatin-based chemotherapy. II. To refine and validate a novel patient-reported measure of hearing outcomes for children, adolescents and young adults with standard risk germ cell tumors. III. To determine whether radiomic measures of body composition at diagnosis, end of therapy, and one year after end of therapy is better correlated with adverse events compared to body surface area in patients receiving chemotherapy for germ cell tumors. EXPLORATORY OBJECTIVES: I. To prospectively determine the correlation of tumor marker decline (alpha-fetoprotein \[FP\] and beta-human chorionic gonadotropin \[HCG\]) with clinical outcome in low and standard risk germ cell tumor patients. II. To compare self-reported peripheral neuropathy and other patient-reported outcomes between children, adolescents and young adults with standard risk germ cell tumors treated with carboplatin-based chemotherapy as compared to cisplatin-based chemotherapy. III. Assess the relationship between hearing loss as measured by audiometry with the effects of tinnitus as assessed on the Adolescent and Young Adult Hearing Screening (AYA-HEARS) instrument. IV. To evaluate the prognostic significance of serum micro ribonucleic acid (miRNA)s in stage I seminoma patients by collecting clinical data and serum specimens for future analysis. V. To compare differences in the proportion of patients with residual mass(es) ≥ 1 cm at the completion of chemotherapy among patients randomized to the cisplatin and carboplatin-containing arms and to compare the proportion undergoing post-chemotherapy surgery for residual mass(es), and the proportion of resected masses with viable malignancy, teratoma, or necrosis. VI. To investigate whether there is an association between serum miRNAs measured immediately post-operatively and time-to-relapse in stage I non-seminomatous germ cell tumor patients and to estimate the trajectory of miRNA over time. OUTLINE: Patients with low-risk stage I grade 2, 3 ovarian immature teratoma or stage I non-seminoma malignant germ cell tumors (MGCT)s undergo observation and can transfer to standard risk arm at time of recurrence if eligibility criteria are met. Patients with stage I seminoma testicular MGCT undergo observation, and those with residual/recurrent disease are treated at the discretion of their physician. Patients undergo computed tomography (CT), magnetic resonance imaging (MRI), and/or chest x-ray as well as blood sample collection throughout the trial to monitor for response and recurrence. Patients may also undergo a tumor biopsy throughout the trial. Patients with standard risk 1 are randomized into 1 of 2 arms. ARM I (CEb): Patients receive bleomycin intravenously (IV) over 10 minutes and carboplatin IV over 1 hour on day 1. Patients also receive etoposide IV over 1-2 hours on days 1-5. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study. ARM II (PEb): Patients receive bleomycin IV over 10 minutes on day 1. Patients also receive etoposide IV over 1-2 hours and cisplatin IV over 1-3 hours on days 1-5. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study. Patients with standard risk 2 are randomized into 1 of 2 arms. ARM III (BEC): Patients receive bleomycin IV over 10 minutes on days 1, 8, and 15, etoposide IV over 1-2 hours on days 1-5, and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study. ARM IV (BEP): Patients receive bleomycin IV over 10 minutes on days 1, 8, and 15, etoposide IV over 1-2 hours on days 1-5, and cisplatin IV over 1-3 hours on days 1-5. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study. After completion of study treatment, patients are followed up every 2 months for 12 months, every 3-6 months to 24 months, every 6 months for years 3-5, and then annually for up to 10 years.
Source references
references
  1. citation
    Trozzi R, Rosati A, Panico C, Perisiano C, Santoro A, Fagotti A. Extra-cranial meningioma associated with relapse of immature ovarian teratoma. Int J Gynecol Cancer. 2023 Oct 2;33(10):1649-1654. doi: 10.1136/ijgc-2023-004718. No abstract available.
    pmid
    37783480
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Source notices and limitations
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      occurrences
      1. context exact
        rm-cell/hp/germ-cell-treatment-pdq#_731">Table 3</a> describes the testicular GCT staging for males younger than 11 years from the COG <a href="/clinicaltrials/NCT03067181">AGCT1531 (NCT03067181)</a> trial.</p> <table id="_731" class="table-default expandable-container"><caption>Table 3. Testicular GCT Staging From the CO
        end
        90638
        exact text
        NCT03067181
        start
        90627
      2. context exact
        eatment-pdq#_731">Table 3</a> describes the testicular GCT staging for males younger than 11 years from the COG <a href="/clinicaltrials/NCT03067181">AGCT1531 (NCT03067181)</a> trial.</p> <table id="_731" class="table-default expandable-container"><caption>Table 3. Testicular GCT Staging From the COG AGCT1531 Trial<span c
        end
        90661
        exact text
        NCT03067181
        start
        90650
      3. context exact
        erm-cell/hp/germ-cell-treatment-pdq#_732">Table 4</a> describes the ovarian GCT staging for females younger than 11 years from the COG <a href="/clinicaltrials/NCT03067181">AGCT1531 (NCT03067181)</a> trial.</p> <table id="_732" class="table-default expandable-container"><caption>Table 4. Ovarian GCT Staging From the COG A
        end
        95897
        exact text
        NCT03067181
        start
        95886
      4. context exact
        reatment-pdq#_732">Table 4</a> describes the ovarian GCT staging for females younger than 11 years from the COG <a href="/clinicaltrials/NCT03067181">AGCT1531 (NCT03067181)</a> trial.</p> <table id="_732" class="table-default expandable-container"><caption>Table 4. Ovarian GCT Staging From the COG AGCT1531 Trial<span clas
        end
        95920
        exact text
        NCT03067181
        start
        95909
      5. context exact
        s/extracranial-germ-cell/hp/germ-cell-treatment-pdq#_733">Table 6</a> describes the extragonadal extracranial GCT staging from the COG <a href="/clinicaltrials/NCT03067181">AGCT1531 (NCT03067181)</a> trial.</p> <table id="_733" class="table-default expandable-container"><caption>Table 6. Extragonadal Extracranial GCT Stagi
        end
        108001
        exact text
        NCT03067181
        start
        107990
      6. context exact
        l/hp/germ-cell-treatment-pdq#_733">Table 6</a> describes the extragonadal extracranial GCT staging from the COG <a href="/clinicaltrials/NCT03067181">AGCT1531 (NCT03067181)</a> trial.</p> <table id="_733" class="table-default expandable-container"><caption>Table 6. Extragonadal Extracranial GCT Staging From the COG AGCT15
        end
        108024
        exact text
        NCT03067181
        start
        108013
      7. context exact
        he strategy of observation after surgery has not been established. This treatment strategy is under investigation in a clinical trial (<a href="/clinicaltrials/NCT03067181">AGCT1531 [NCT03067181]</a>).</td> </tr> </TFoot> <tbody> <tr> <td colspan="3"> <stro
        end
        119452
        exact text
        NCT03067181
        start
        119441
      8. context exact
        ion after surgery has not been established. This treatment strategy is under investigation in a clinical trial (<a href="/clinicaltrials/NCT03067181">AGCT1531 [NCT03067181]</a>).</td> </tr> </TFoot> <tbody> <tr> <td colspan="3"> <strong>Mature teratoma</str
        end
        119475
        exact text
        NCT03067181
        start
        119464
      9. context exact
        institutional clinical trial that is currently being conducted:</p> <div class="pdq-content-list"><ol id="_758"><li><strong><a href="/clinicaltrials/NCT03067181">AGCT1531 (NCT03067181)</a></strong> (Active Surveillance, Bleomycin, Carboplatin, Etoposide, or Cisplatin in Treating Pediatric and Adult Patients with GCTs)<
        end
        162587
        exact text
        NCT03067181
        start
        162576
      10. context exact
        trial that is currently being conducted:</p> <div class="pdq-content-list"><ol id="_758"><li><strong><a href="/clinicaltrials/NCT03067181">AGCT1531 (NCT03067181)</a></strong> (Active Surveillance, Bleomycin, Carboplatin, Etoposide, or Cisplatin in Treating Pediatric and Adult Patients with GCTs)<strong>:</strong> Patie
        end
        162610
        exact text
        NCT03067181
        start
        162599
      11. context exact
        institutional clinical trial that is currently being conducted:</p> <div class="pdq-content-list"><ol id="_744"><li><strong><a href="/clinicaltrials/NCT03067181">AGCT1531 (NCT03067181)</a></strong> (Active Surveillance, Bleomycin, Carboplatin, Etoposide, or Cisplatin in Treating Pediatric and Adult Patients with GCTs)<
        end
        191073
        exact text
        NCT03067181
        start
        191062
      12. context exact
        trial that is currently being conducted:</p> <div class="pdq-content-list"><ol id="_744"><li><strong><a href="/clinicaltrials/NCT03067181">AGCT1531 (NCT03067181)</a></strong> (Active Surveillance, Bleomycin, Carboplatin, Etoposide, or Cisplatin in Treating Pediatric and Adult Patients with GCTs)<strong>:</strong> The a
        end
        191096
        exact text
        NCT03067181
        start
        191085
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      source title
      Childhood Extracranial Germ Cell Tumors Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: November 5, 2024
        datetime
        2024-11-05T12:00:00Z
        display
        November 5, 2024

    Preserved source evidence · Not medical advice