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NCT02567435 · CITED IN SOURCE DOCUMENTS

Combination Chemotherapy With or Without Temsirolimus in Treating Patients With Intermediate Risk Rhabdomyosarcoma

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
ACTIVE NOT RECRUITING
Registry last update
2026-08-28

This randomized phase III trial studies how well combination chemotherapy (vincristine sulfate, dactinomycin, cyclophosphamide alternated with vincristine sulfate and irinotecan hydrochloride or vinorelbine) works compared to combination chemotherapy plus temsirolimus in treating patients with rhabdomyosarcoma (cancer that forms in the soft tissues, such as muscle), and has an intermediate chance of coming back after treatment (intermediate risk). Drugs used 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. Combination chemotherapy and temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether chemotherapy plus temsirolimus is more effective than chemotherapy alone in treating patients with intermediate-risk rhabdomyosarcoma.

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What did the study report?

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

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Event-free Survival (EFS)

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outcome · POSTED

Overall Survival (OS)

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outcome · NOT POSTED

Frequency of Circulating Tumor DNA (ctDNA) at Diagnosis and Subsequent Time-points

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outcome · NOT POSTED

Patient Outcome Based on Their Forkhead Box O1 Protein (FOXO1) Partner, by Evaluating PAX3 vs. PAX7 in All Patients Found to be FOXO1 Fusion Positive

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outcome · NOT POSTED

Patient Outcome Based on Their [F18]-Fluorodeoxy-D-glucose-positron Emission Tomography (FDG-positron Emission Tomography [PET]) Response

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outcome · NOT POSTED

Patient Outcomes Based on (Vincristine, Dactinomycin, and Cyclophosphamide [VAC]/Vincristine and Irinotecan [VI] With or Without Temsirolimus) Who Have Received Maintenance Therapy on ARST1431 to Those Who Received VAC/VI on ARST0531

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Feasibility Phase: Patients must be \< 21 years of age at the time of enrollment; please note: the feasibility phase is complete, effective with amendment #1 * Efficacy Phase: Patients must be =\< 40 years of age at the time of enrollment * Patients with newly diagnosed RMS of any subtype, except adult-type pleomorphic, based upon institutional histopathologic classification, are eligible to enroll on the study based upon stage, group, and age, as below * RMS types included under embryonal rhabdomyosarcoma (ERMS) include those classified in the 1995 International Classification of Rhabdomyosarcoma (ICR) as ERMS (classic, spindle cell, and botryoid variants), which are reclassified in the 2013 World Health Organization (WHO) classification as ERMS (classic, dense and botryoid variants) and spindle cell/sclerosing RMS (encompassing the historical spindle cell ERMS variant and the newly recognized sclerosing RMS variant); classification of alveolar rhabdomyosarcoma (ARMS) in the 2013 WHO classification is the same as in the ICR and includes classic and solid variants * ERMS * Stage 1, group III (non-orbit) * Stage 3, group I/II * Stage 2/3, group III * Stage 4, group IV, \< 10 years old * ARMS: * Stages 1-3, groups I-III * Specimen Submission: Patients must have sufficient tissue available for the required biology study * Lansky performance status score \>= 50 for patients =\< 16 years of age; Karnofsky performance status score \>= 50 for patients \> 16 years of age * Peripheral absolute neutrophil count (ANC) \>= 750/uL * Platelet count \>= 75,000/uL * Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 or a serum creatinine based on age/gender as follows: * 1 month to \< 6 months old: 0.4 mg/dl (male), 0.4 mg/dl (female) * 6 months to \< 1 year old: 0.5 mg/dl (male), 0.5 mg/dl (female) * 1 to \< 2 years old: 0.6 mg/dl (male), 0.6 mg/dl (female) * 2 to \< 6 years old: 0.8 mg/dl (male), 0.8 mg/dl (female) * 6 to \< 10 years old: 1 mg/dl (male), 1 mg/dl (female) * 10 to \< 13 years old: 1.2 mg/dl (male), 1.2 mg/dl (female) * 13 to \< 16 years old: 1.5 mg/dl (male), 1.4 mg/dl (female) * \>= 16 years old: 1.7 mg/dl (male), 1.4 mg/dl (female) * Patients with an elevated serum creatinine due to obstructive hydronephrosis secondary to tumor are still eligible; however, patients with urinary tract obstruction by tumor must have unimpeded urinary flow established via diversion (i.e. percutaneous nephrostomies or ureteric stents) of the urinary tract * Total bilirubin =\< 1.5 x upper limit of normal (ULN) for age * All patients and/or their parents or legal guardians must sign a written informed consent. * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met. Exclusion Criteria: * Patients who have previously received temsirolimus, another mTOR inhibitor, or any other investigational agent * Patients who have received any chemotherapy (excluding steroids) and/or RT prior to this enrollment * Patients with uncontrolled hyperglycemia * Patients with uncontrolled hyperlipidemia * Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation and for at least 3 months after treatment is completed * Female patients who are pregnant are not eligible since fetal toxicities or teratogenic effects have been noted for several of the study drugs; Note: A pregnancy test is required for female patients of childbearing potential prior to study entry * Lactating females who plan to breastfeed their infants are not eligible
healthy Volunteers
false
maximum Age
40 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37. Patients also undergo primary site RT beginning at week 13 or metastatic site RT beginning at week 43 for up to 6.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide PO QD on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity.
    intervention Names
    1. Drug: Cyclophosphamide
    2. Biological: Dactinomycin
    3. Drug: Irinotecan Hydrochloride
    4. Other: Laboratory Biomarker Analysis
    5. Other: Questionnaire Administration
    6. Radiation: Radiation Therapy
    7. Drug: Vincristine Sulfate
    label
    Regimen A (VAC/VI)
    type
    EXPERIMENTAL
  2. description
    Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37 and temsirolimus IV over 30-60 minutes on day 1 of weeks 1-12 and 21-42. Patients also undergo RT as in Regimen A. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide PO QD on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity.
    intervention Names
    1. Drug: Cyclophosphamide
    2. Biological: Dactinomycin
    3. Drug: Irinotecan Hydrochloride
    4. Other: Laboratory Biomarker Analysis
    5. Other: Questionnaire Administration
    6. Radiation: Radiation Therapy
    7. Drug: Temsirolimus
    8. Drug: Vincristine Sulfate
    9. Drug: Vinorelbine
    label
    Regimen B (VAC/VI/temsirolimus)
    type
    EXPERIMENTAL
  3. description
    Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-10 and 13-22, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, and 22, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 4, 7, and 10. Patients undergo RT beginning at week 13 for up to 6.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
    intervention Names
    1. Drug: Cyclophosphamide
    2. Biological: Dactinomycin
    3. Other: Laboratory Biomarker Analysis
    4. Other: Questionnaire Administration
    5. Radiation: Radiation Therapy
    6. Drug: Vincristine Sulfate
    label
    Regimen C (FOXO1 fusion negative, VAC/VA)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Regimen A (VAC/VI)
    2. Regimen B (VAC/VI/temsirolimus)
    3. Regimen C (FOXO1 fusion negative, VAC/VA)
    description
    Given IV and PO
    name
    Cyclophosphamide
    other Names
    1. (-)-Cyclophosphamide
    2. 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
    3. Asta B 518
    4. B 518
    5. B-518
    6. B518
    7. Carloxan
    8. Ciclofosfamida
    9. Ciclofosfamide
    10. Cicloxal
    11. Clafen
    12. Claphene
    type
    DRUG
  2. arm Group Labels
    1. Regimen A (VAC/VI)
    2. Regimen B (VAC/VI/temsirolimus)
    3. Regimen C (FOXO1 fusion negative, VAC/VA)
    description
    Given IV
    name
    Dactinomycin
    other Names
    1. Actinomycin A IV
    2. Actinomycin C1
    3. Actinomycin D
    4. Actinomycin I1
    5. Actinomycin IV
    6. Actinomycin X 1
    7. Actinomycin-[thr-val-pro-sar-meval]
    8. Cosmegen
    9. DACT
    10. Dactinomycine
    11. Lyovac Cosmegen
    12. Meractinomycin
    type
    BIOLOGICAL
  3. arm Group Labels
    1. Regimen A (VAC/VI)
    2. Regimen B (VAC/VI/temsirolimus)
    description
    Given IV
    name
    Irinotecan Hydrochloride
    other Names
    1. Campto
    2. Camptosar
    3. Camptothecin 11
    4. Camptothecin-11
    5. CPT 11
    6. CPT-11
    7. CPT11
    8. Irinomedac
    9. Irinotecan Hydrochloride Trihydrate
    10. Irinotecan Monohydrochloride Trihydrate
    11. U 101440E
    12. U-101440E
    type
    DRUG
  4. arm Group Labels
    1. Regimen A (VAC/VI)
    2. Regimen B (VAC/VI/temsirolimus)
    3. Regimen C (FOXO1 fusion negative, VAC/VA)
    description
    Correlative studies
    name
    Laboratory Biomarker Analysis
    type
    OTHER
  5. arm Group Labels
    1. Regimen A (VAC/VI)
    2. Regimen B (VAC/VI/temsirolimus)
    3. Regimen C (FOXO1 fusion negative, VAC/VA)
    description
    Ancillary studies
    name
    Questionnaire Administration
    type
    OTHER
  6. arm Group Labels
    1. Regimen A (VAC/VI)
    2. Regimen B (VAC/VI/temsirolimus)
    3. Regimen C (FOXO1 fusion negative, VAC/VA)
    description
    Undergo RT
    name
    Radiation Therapy
    other Names
    1. Cancer Radiotherapy
    2. Energy Type
    3. ENERGY_TYPE
    4. Irradiate
    5. Irradiated
    6. Irradiation
    7. Radiation
    8. Radiation Therapy, NOS
    9. Radiotherapeutics
    10. Radiotherapy
    11. RT
    12. Therapy, Radiation
    type
    RADIATION
  7. arm Group Labels
    1. Regimen B (VAC/VI/temsirolimus)
    description
    Given IV
    name
    Temsirolimus
    other Names
    1. CCI 779
    2. CCI-779
    3. CCI-779 Rapamycin Analog
    4. CCI779
    5. Cell Cycle Inhibitor 779
    6. Rapamycin Analog
    7. Rapamycin Analog CCI-779
    8. Torisel
    type
    DRUG
  8. arm Group Labels
    1. Regimen A (VAC/VI)
    2. Regimen B (VAC/VI/temsirolimus)
    3. Regimen C (FOXO1 fusion negative, VAC/VA)
    description
    Given IV
    name
    Vincristine Sulfate
    other Names
    1. Kyocristine
    2. Leurocristine Sulfate
    3. Leurocristine, sulfate
    4. Oncovin
    5. Vincasar
    6. Vincosid
    7. Vincrex
    8. Vincristine, sulfate
    type
    DRUG
  9. arm Group Labels
    1. Regimen B (VAC/VI/temsirolimus)
    description
    Given IV
    name
    Vinorelbine
    other Names
    1. Dihydroxydeoxynorvinkaleukoblastine
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
325
type
ACTUAL
Registered outcome plans (not posted results)
other Outcomes
  1. description
    Will determine the frequency with which of ctDNA is detected in patients with intermediate-risk (IR) rhabdomyosarcoma (RMS) at diagnosis and how these levels change over time with. In addition, the level of ctDNA as a percent of total cell-free DNA will be summarized by reporting the median and range. Since no prior data are available on the rate of positivity nor the change over time, the analysis will be purely descriptive. Changes over time will be plotted to visually determine and compare the trajectories of ctDNA during the early and late stages of therapy.
    measure
    Frequency of Circulating Tumor DNA (ctDNA) at Diagnosis and Subsequent Time-points
    time Frame
    Up to 10 years
  2. measure
    Patient Outcome Based on Their Forkhead Box O1 Protein (FOXO1) Partner, by Evaluating PAX3 vs. PAX7 in All Patients Found to be FOXO1 Fusion Positive
    time Frame
    Up to 10 years
  3. description
    Assessed by Deauville Criteria (5-point).
    measure
    Patient Outcome Based on Their [F18]-Fluorodeoxy-D-glucose-positron Emission Tomography (FDG-positron Emission Tomography [PET]) Response
    time Frame
    At week 9
  4. description
    The two-sample log-rank test will be performed.
    measure
    Patient Outcomes Based on (Vincristine, Dactinomycin, and Cyclophosphamide [VAC]/Vincristine and Irinotecan [VI] With or Without Temsirolimus) Who Have Received Maintenance Therapy on ARST1431 to Those Who Received VAC/VI on ARST0531
    time Frame
    Up to 10 years
primary Outcomes
  1. description
    The Kaplan-Meier method will used to estimate 3-year EFS between the randomized treatment groups (Regimen A (VAC/VI) vs. Regimen B (VAC/VI/Temsirolimus)) using the log-rank test. EFS event is defined as the time from study entry until first occurrence of progression, relapse, second malignancy, or death.
    measure
    Event-free Survival (EFS)
    time Frame
    Up to 3 years from study entry
secondary Outcomes
  1. description
    The Kaplan-Meier method will used to estimate 3-year OS between the randomized treatment groups (Regimen A (VAC/VI) vs. Regimen B (VAC/VI/Temsirolimus)) using the log-rank test. OS event is defined as the time from study entry until death.
    measure
    Overall Survival (OS)
    time Frame
    Up to 3 years from study entry
Full study description
brief Summary
This randomized phase III trial studies how well combination chemotherapy (vincristine sulfate, dactinomycin, cyclophosphamide alternated with vincristine sulfate and irinotecan hydrochloride or vinorelbine) works compared to combination chemotherapy plus temsirolimus in treating patients with rhabdomyosarcoma (cancer that forms in the soft tissues, such as muscle), and has an intermediate chance of coming back after treatment (intermediate risk). Drugs used 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. Combination chemotherapy and temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether chemotherapy plus temsirolimus is more effective than chemotherapy alone in treating patients with intermediate-risk rhabdomyosarcoma.
detailed Description
PRIMARY OBJECTIVE: I. To compare the event-free survival (EFS) of patients with intermediate-risk (IR) rhabdomyosarcoma (RMS) treated with surgery, radiotherapy, and vincristine (vincristine sulfate), dactinomycin, and cyclophosphamide (VAC) alternating with vincristine and irinotecan (irinotecan hydrochloride) (VI) (VAC/VI) with maintenance to that of patients treated with surgery, radiotherapy and VAC/VI plus temsirolimus with maintenance. SECONDARY OBJECTIVE: I. To compare the overall survival (OS) of patients with IR RMS treated with surgery, radiotherapy, and VAC alternating with VI with maintenance to that of patients treated with surgery, radiotherapy and VAC/VI plus temsirolimus with maintenance. EXPLORATORY OBJECTIVES: I. To compare the outcome of patients based on their FOXO1 fusion gene partner, by evaluating PAX3 versus (vs) PAX7 in all patients found to be FOXO1 fusion positive. II. To compare the outcome of patients based on their \[F18\]-fluorodeoxy-D-glucose-positron emission tomography (FDG-PET) response at week 9 (positive or negative), as assessed by Deauville criteria (5-point). III. To estimate the frequency of patients with circulating tumor deoxyribonucleic acid (DNA) (ctDNA) at diagnosis and subsequent time-points, and explore whether tumor-specific somatic variants are detectable in the ctDNA. IV. To compare the outcome of patients (VAC/VI with or without temsirolimus) who have received maintenance therapy on ARST1431 to those who received VAC/VI on ARST0531. OUTLINE: FEASIBILITY PHASE (THE FEASIBILITY PHASE IS COMPLETE, EFFECTIVE WITH AMENDMENT #1A): (\< 21 years old): This is a dose-escalation study of temsirolimus. Patients receive vincristine sulfate intravenously (IV) over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37, and temsirolimus IV over 30-60 minutes on days 1, 8, and 15. Patients also undergo radiation therapy (RT) beginning week 13 for up to 6.5 weeks. Courses with temsirolimus repeat every 21 days for 12 weeks in the absence of disease progression or unacceptable toxicity. EFFICACY PHASE: Patients are randomized to Regimen A or B. Patients with disease that is ARMS FOXO1 fusion negative (stage I, group I/II, stage 1, group III \[orbit\] or stage II, group I/II) are assigned to Regimen C. REGIMEN A (VAC/VI): Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37. Patients also undergo primary site RT beginning at week 13 or metastatic site RT beginning at week 43 for up to 6.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide orally (PO) once daily (QD) on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity. REGIMEN B (VAC/VI TEMSIROLIMUS): Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37 and temsirolimus IV over 30-60 minutes on day 1 of weeks 1-12 and 21-42. Patients also undergo RT as in Regimen A. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide PO QD on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE (Patients in Regimen A or Regimen B): Patients receive vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide orally (PO) once daily (QD) on days 1-28. Treatment repeats every 28 days for up to 6 cycles. REGIMEN C (FOXO1 FUSION NEGATIVE): Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-10 and 13-22, dactinomycin IV over 1-5 or 10-15 minutes on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, and 22, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 4, 7, and 10. Patients undergo RT beginning at week 13 for up to 6.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 1 year, every 4 months for 2 years, every 6 months for 1 year, and then annually for up to 10 years.
Source references
references
  1. citation
    Winsnes K, Bradley JA, Gao Z, Gupta AA, Rothstein DH, Shenoy A, Venkatramani R, Xue W, Arndt C. Intermediate Risk Rhabdomyosarcoma in Very Young Children (Less Than or Equal to 24 Months) Treated on the Prior Children's Oncology Group Protocol ARST1431. Pediatr Blood Cancer. 2026 Jun;73(6):e70293. doi: 10.1002/1545-5017.70293. Epub 2026 Mar 31.
    pmid
    41914453
    type
    DERIVED
  2. citation
    Gupta AA, Xue W, Harrison DJ, Hawkins DS, Dasgupta R, Wolden S, Shulkin B, Qumseya A, Routh JC, MacDonald T, Feinberg S, Crompton B, Rudzinski ER, Arnold M, Venkatramani R. Addition of temsirolimus to chemotherapy in children, adolescents, and young adults with intermediate-risk rhabdomyosarcoma (ARST1431): a randomised, open-label, phase 3 trial from the Children's Oncology Group. Lancet Oncol. 2024 Jul;25(7):912-921. doi: 10.1016/S1470-2045(24)00255-9.
    pmid
    38936378
    type
    DERIVED
  3. citation
    de Traux de Wardin H, Dermawan JK, Vanoli F, Jiang SC, Singer S, Chi P, Tap W, Wexler LH, Antonescu CR. NF1-Driven Rhabdomyosarcoma Phenotypes: A Comparative Clinical and Molecular Study of NF1-Mutant Rhabdomyosarcoma and NF1-Associated Malignant Triton Tumor. JCO Precis Oncol. 2024 Apr;8:e2300597. doi: 10.1200/PO.23.00597.
    pmid
    38603649
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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      occurrences
      1. context exact
        tive trials in the United Kingdom. Fusion status has now been incorporated into the risk stratification of patients in the current COG <a href="/clinicaltrials/NCT02567435">ARST1431 (NCT02567435)</a> study for patients with intermediate-risk rhabdomyosarcoma, in subsequent COG trials, and in the new international EpSSG trial.[<a
        end
        57051
        exact text
        NCT02567435
        start
        57040
      2. context exact
        ed Kingdom. Fusion status has now been incorporated into the risk stratification of patients in the current COG <a href="/clinicaltrials/NCT02567435">ARST1431 (NCT02567435)</a> study for patients with intermediate-risk rhabdomyosarcoma, in subsequent COG trials, and in the new international EpSSG trial.[<a href="#cit/section_1.74
        end
        57074
        exact text
        NCT02567435
        start
        57063
      3. context exact
        <p id="_469" tabindex="-1">The current trial for intermediate-risk patients from the Soft Tissue Sarcoma Committee of the COG (<a href="/clinicaltrials/NCT02567435">ARST1431 [NCT02567435]</a>) and all future trials will use fusion status rather than histology to determine eligibility. Fusion-negative patients with alveola
        end
        136338
        exact text
        NCT02567435
        start
        136327
      4. context exact
        bindex="-1">The current trial for intermediate-risk patients from the Soft Tissue Sarcoma Committee of the COG (<a href="/clinicaltrials/NCT02567435">ARST1431 [NCT02567435]</a>) and all future trials will use fusion status rather than histology to determine eligibility. Fusion-negative patients with alveolar histology will underg
        end
        136361
        exact text
        NCT02567435
        start
        136350
      5. context exact
        the visible disease at the time of RT.</li><li>Eight patients with local recurrences had tumors larger than 5 cm at diagnosis. The COG <a href="/clinicaltrials/NCT02567435">ARST1431 (NCT02567435)</a> protocol is testing escalated doses to 59.4 Gy for these patients.</li><li>This study did not delineate whether the recurrence was
        end
        261951
        exact text
        NCT02567435
        start
        261940
      6. context exact
        the time of RT.</li><li>Eight patients with local recurrences had tumors larger than 5 cm at diagnosis. The COG <a href="/clinicaltrials/NCT02567435">ARST1431 (NCT02567435)</a> protocol is testing escalated doses to 59.4 Gy for these patients.</li><li>This study did not delineate whether the recurrence was in the 41.4 Gy or 50.4
        end
        261974
        exact text
        NCT02567435
        start
        261963
      7. context exact
        e reduction for invasive tumors. 59.4 Gy boost to residual disease at 9 weeks for tumors &gt;5 cm at diagnosis (if enrolled on the COG <a href="/clinicaltrials/NCT02567435">ARST1431 [NCT02567435]</a>) protocol.</td> </tr> <tr> <td>N1 with gross residual disease after surgery/chemotherap
        end
        265042
        exact text
        NCT02567435
        start
        265031
      8. context exact
        e tumors. 59.4 Gy boost to residual disease at 9 weeks for tumors &gt;5 cm at diagnosis (if enrolled on the COG <a href="/clinicaltrials/NCT02567435">ARST1431 [NCT02567435]</a>) protocol.</td> </tr> <tr> <td>N1 with gross residual disease after surgery/chemotherapy</td>
        end
        265065
        exact text
        NCT02567435
        start
        265054
      9. context exact
        15 Gy depending on age.</td> </tr> </tbody> </table> <p id="_819" tabindex="-1">In the COG <a href="/clinicaltrials/NCT02567435">ARST1431 (NCT02567435)</a> study, risk group is in part determined by fusion status. The recommended dose of RT depends on the amount of residual disease, if
        end
        265811
        exact text
        NCT02567435
        start
        265800
      10. context exact
        </td> </tr> </tbody> </table> <p id="_819" tabindex="-1">In the COG <a href="/clinicaltrials/NCT02567435">ARST1431 (NCT02567435)</a> study, risk group is in part determined by fusion status. The recommended dose of RT depends on the amount of residual disease, if any, after the initial
        end
        265834
        exact text
        NCT02567435
        start
        265823
      11. context exact
        cyclophosphamide. These patients (Stage I, Group III nonorbit and Stage 3, Group I/II) are now being treated in the intermediate-risk <a href="/clinicaltrials/NCT02567435">ARST1431 (NCT02567435)</a> trial.</li></ul></div></li><li>For patients with an orbital primary tumor who achieved only a partial response or stability after 1
        end
        364770
        exact text
        NCT02567435
        start
        364759
      12. context exact
        e patients (Stage I, Group III nonorbit and Stage 3, Group I/II) are now being treated in the intermediate-risk <a href="/clinicaltrials/NCT02567435">ARST1431 (NCT02567435)</a> trial.</li></ul></div></li><li>For patients with an orbital primary tumor who achieved only a partial response or stability after 12 weeks of induction ch
        end
        364793
        exact text
        NCT02567435
        start
        364782
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      1. context
        Updated: April 11, 2025
        datetime
        2025-04-11T12:00:00Z
        display
        April 11, 2025

    Preserved source evidence · Not medical advice