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NCT00352534 · CITED IN SOURCE DOCUMENTS

Vincristine, Dactinomycin, and Doxorubicin With or Without Radiation Therapy or Observation Only in Treating Younger Patients Who Are Undergoing Surgery for Newly Diagnosed Stage I, Stage II, or Stage III Wilms' Tumor

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
COMPLETED
Registry last update
2026-06-03

This phase III trial is studying vincristine, dactinomycin, and doxorubicin with or without radiation therapy or observation only to see how well they work in treating patients undergoing surgery for newly diagnosed stage I, stage II, or stage III Wilms' tumor. Drugs used in chemotherapy, such as vincristine, dactinomycin, and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors.Giving these treatments after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient.

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.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Event Free Survival Probability

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outcome · POSTED

Overall Survival (OS) Probability

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outcome · POSTED

Incidence of Contralateral Kidney Lesions

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outcome · POSTED

Incidence of Renal Failure

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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: * Histologically confirmed Wilms' tumor * Newly diagnosed stage I-III disease * Favorable histology * No moderate- or high-risk Wilms' predisposition syndromes * Must meet 1 of the following disease stratification categories: * Very low-risk disease * Stage I disease * Age \< 2 years * Tumor weight \< 550 g * Regional lymph nodes histologically negative (must have been sampled) * No pulmonary metastases on CT scan of chest * No synchronous bilateral Wilms tumors (Stage V) * Not predisposed to develop bilateral Wilms tumors, defined as unilateral Wilms tumor and any of the following: * Aniridia * Beckwith-Wiedemann syndrome * Simpson-Golabi-Behmel syndrome * Denys-Drash syndrome or other associated genito-urinary anomalies * Multicentric WT or unilateral WT with contralateral nephrogenic rest(s) in a child \< 1 year of age * Diffuse hyperplastic perilobar nephroblastomatosis * Standard-risk disease meeting 1 of the following criteria: * Disease does not require radiotherapy * LOH at chromosomes 1p and 16q for stage I or II * Stage I disease meeting 1 of the following criteria: * Age ≥ 2 years to age \< 30 years * Tumor weight ≥ 500 g * Stage II disease * Age \< 30 years * Any tumor weight * Disease requires radiotherapy * No LOH at chromosomes 1p and 16q\* * Stage III disease * Must be enrolled on protocol COG-AREN03B2 * Karnofsky performance status (PS) 50-100% for patients \> 16 years old * Lansky PS 50-100% for patients ≤ 16 years old * Bilirubin (direct) ≤ 1.5 times upper limit of normal (ULN) * AST or ALT \< 2.5 times ULN * Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 50% by radionuclide angiogram (standard-risk disease) * Not pregnant or nursing * Negative pregnancy test * Fertile patient must use effective contraception * No prior tumor-directed chemotherapy or radiotherapy * Patients transferring from AREN03B2 with LOH 1p and 16q allowed
healthy Volunteers
false
maximum Age
29 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients undergo nephrectomy only. If they meet criteria, they are then observed periodically for 5 years. Patients with recurrent disease undergo surgery (immediate or delayed) and receive chemotherapy as in stratum III. Patients with no metachronous renal disease receive radiotherapy. Patients with metachronous disease undergo renal-sparing surgery and chemotherapy as in stratum III, but no radiotherapy. Treatment continues for up to 25 weeks. Additionally, patients undergo chest X-ray, CT or MRI, ultrasound, echocardiography, and blood sample collection throughout the study.
    intervention Names
    1. Radiation: 3-Dimensional Conformal Radiation Therapy
    2. Procedure: Biospecimen Collection
    3. Procedure: Chest Radiography
    4. Procedure: Computed Tomography
    5. Biological: Dactinomycin
    6. Drug: Doxorubicin Hydrochloride
    7. Procedure: Echocardiography Test
    8. Procedure: Magnetic Resonance Imaging
    9. Procedure: Therapeutic Conventional Surgery
    10. Procedure: Ultrasound Imaging
    11. Drug: Vincristine Sulfate
    label
    Stratum I (very low-risk disease)
    type
    EXPERIMENTAL
  2. description
    Patients undergo nephrectomy. Between 9 and 14 days post-nephrectomy, patients receive vincristine IV beginning on day 1, every week for 10 weeks then every 3 weeks for a total of 15 doses. Patients receive dactinomycin IV beginning day 1, alternating every 3 weeks with doxorubicin hydrochloride IV for a total of 5 doses of dactinomycin and 4 doses of doxorubicin. Treatment continues for up to 25 weeks. Additionally, patients undergo chest X-ray, CT or MRI, ultrasound, echocardiography, and blood sample collection throughout the study.
    intervention Names
    1. Radiation: 3-Dimensional Conformal Radiation Therapy
    2. Procedure: Biospecimen Collection
    3. Procedure: Chest Radiography
    4. Procedure: Computed Tomography
    5. Biological: Dactinomycin
    6. Drug: Doxorubicin Hydrochloride
    7. Procedure: Echocardiography Test
    8. Procedure: Magnetic Resonance Imaging
    9. Procedure: Therapeutic Conventional Surgery
    10. Procedure: Ultrasound Imaging
    11. Drug: Vincristine Sulfate
    label
    Stratum II (standard-risk, stage I or II)
    type
    EXPERIMENTAL
  3. description
    Patients undergo nephrectomy, if feasible, or biopsy. For patients who undergo biopsy only, definitive surgery is undertaken at week 7 or 13. Between 9 and 14 days post-nephrectomy, patients receive vincristine IV beginning on day 1 every week for 10 weeks then every 3 weeks for a total of 15 doses. Patients receive dactinomycin IV beginning day 1, alternating every 3 weeks with doxorubicin hydrochloride IV for a total of 5 doses of dactinomycin and 4 dose of doxorubicin hydrochloride. Patients undergo radiotherapy over 5-7 days after nephrectomy. Treatment continues for up to 25 weeks. Additionally, patients undergo chest X-ray, CT or MRI, ultrasound, echocardiography, and blood sample collection throughout the study.
    intervention Names
    1. Radiation: 3-Dimensional Conformal Radiation Therapy
    2. Procedure: Biospecimen Collection
    3. Procedure: Chest Radiography
    4. Procedure: Computed Tomography
    5. Biological: Dactinomycin
    6. Drug: Doxorubicin Hydrochloride
    7. Procedure: Echocardiography Test
    8. Procedure: Magnetic Resonance Imaging
    9. Procedure: Therapeutic Conventional Surgery
    10. Procedure: Ultrasound Imaging
    11. Drug: Vincristine Sulfate
    label
    Stratum III (standard-risk, stage III)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Stratum I (very low-risk disease)
    2. Stratum II (standard-risk, stage I or II)
    3. Stratum III (standard-risk, stage III)
    description
    Patients undergo radiotherapy
    name
    3-Dimensional Conformal Radiation Therapy
    other Names
    1. 3-dimensional radiation therapy
    2. 3D Conformal
    3. 3D CONFORMAL RADIATION THERAPY
    4. 3D CRT
    5. 3D radiotherapy
    6. 3D-CRT
    7. Conformal Therapy
    8. Radiation Conformal Therapy
    9. Radiation, 3D Conformal
    10. Three dimensional external beam radiation therapy (procedure)
    type
    RADIATION
  2. arm Group Labels
    1. Stratum I (very low-risk disease)
    2. Stratum II (standard-risk, stage I or II)
    3. Stratum III (standard-risk, stage III)
    description
    Undergo blood sample collection
    name
    Biospecimen Collection
    other Names
    1. Biological Sample Collection
    2. Biospecimen Collected
    3. Sample Collection
    4. Specimen Collection
    type
    PROCEDURE
  3. arm Group Labels
    1. Stratum I (very low-risk disease)
    2. Stratum II (standard-risk, stage I or II)
    3. Stratum III (standard-risk, stage III)
    description
    Undergo chest X-ray
    name
    Chest Radiography
    other Names
    1. Chest X-ray
    type
    PROCEDURE
  4. arm Group Labels
    1. Stratum I (very low-risk disease)
    2. Stratum II (standard-risk, stage I or II)
    3. Stratum III (standard-risk, stage III)
    description
    Undergo CT
    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
  5. arm Group Labels
    1. Stratum I (very low-risk disease)
    2. Stratum II (standard-risk, stage I or II)
    3. Stratum III (standard-risk, stage III)
    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
  6. arm Group Labels
    1. Stratum I (very low-risk disease)
    2. Stratum II (standard-risk, stage I or II)
    3. Stratum III (standard-risk, stage III)
    description
    Given IV
    name
    Doxorubicin Hydrochloride
    other Names
    1. 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
    2. ADM
    3. Adriacin
    4. Adriamycin
    5. Adriamycin Hydrochloride
    6. Adriamycin PFS
    7. Adriamycin RDF
    8. ADRIAMYCIN, HYDROCHLORIDE
    9. Adriamycine
    10. Adriblastina
    11. Adriblastine
    12. Adrimedac
    type
    DRUG
  7. arm Group Labels
    1. Stratum I (very low-risk disease)
    2. Stratum II (standard-risk, stage I or II)
    3. Stratum III (standard-risk, stage III)
    description
    Undergo echocardiography
    name
    Echocardiography Test
    other Names
    1. EC
    2. Echocardiography
    type
    PROCEDURE
  8. arm Group Labels
    1. Stratum I (very low-risk disease)
    2. Stratum II (standard-risk, stage I or II)
    3. Stratum III (standard-risk, stage III)
    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
  9. arm Group Labels
    1. Stratum I (very low-risk disease)
    2. Stratum II (standard-risk, stage I or II)
    3. Stratum III (standard-risk, stage III)
    description
    Undergo surgery
    name
    Therapeutic Conventional Surgery
    type
    PROCEDURE
  10. arm Group Labels
    1. Stratum I (very low-risk disease)
    2. Stratum II (standard-risk, stage I or II)
    3. Stratum III (standard-risk, stage III)
    description
    Undergo ultrasound
    name
    Ultrasound Imaging
    other Names
    1. 2-Dimensional Grayscale Ultrasound Imaging
    2. 2-Dimensional Ultrasound Imaging
    3. 2D-US
    4. Ultrasonography
    5. Ultrasound
    6. Ultrasound Test
    7. Ultrasound, Medical
    8. US
    type
    PROCEDURE
  11. arm Group Labels
    1. Stratum I (very low-risk disease)
    2. Stratum II (standard-risk, stage I or II)
    3. Stratum III (standard-risk, stage III)
    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
Study design
allocation
NON_RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
808
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Probability of no relapse, secondary malignancy, or death after 4 year in the study.
    measure
    Event Free Survival Probability
    time Frame
    4 years
  2. description
    Probability of being alive after 4 years in the study.
    measure
    Overall Survival (OS) Probability
    time Frame
    4 years
secondary Outcomes
  1. description
    Number of contralateral kidney lesions during follow-up.
    measure
    Incidence of Contralateral Kidney Lesions
    time Frame
    During follow-up
  2. description
    Number of renal failures defined as requiring dialysis or renal transplant as determined by low GFR during follow-up
    measure
    Incidence of Renal Failure
    time Frame
    During follow-up
Full study description
brief Summary
This phase III trial is studying vincristine, dactinomycin, and doxorubicin with or without radiation therapy or observation only to see how well they work in treating patients undergoing surgery for newly diagnosed stage I, stage II, or stage III Wilms' tumor. Drugs used in chemotherapy, such as vincristine, dactinomycin, and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors.Giving these treatments after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient.
detailed Description
PRIMARY OBJECTIVES: I. Evaluate the overall and event-free survival of younger patients with newly diagnosed stage I favorable histology Wilms' tumor (\< 2 years of age and \< 550gms) treated with nephrectomy only (very low risk), or with newly diagnosed stage III favorable histology Wilms tumor with possible nephrectomy followed by vincristine, dactinomycin, doxorubicin hydrochloride, and radiotherapy (standard risk). SECONDARY OBJECTIVES: I. Determine the effects of adding doxorubicin hydrochloride to the regimen for patients with stage I or II favorable histology found to have a high-risk biological marker. II. Determine whether the omission of adjuvant therapy increases the incidence of contralateral kidney lesions in patients with very low-risk disease treated by nephrectomy and observation only. III. Determine whether the omission of adjuvant therapy increases the incidence of renal failure in patients with very low-risk disease who have metachronous relapse. IV. Correlate study outcomes in patients with standard-risk disease with biological data from tissue collections on protocol study COG-AREN03B2. OUTLINE: This is a multicenter study. Patients are stratified according to clinical and biological risk factors (very low risk vs standard risk). STRATUM I: (very low-risk disease) Patients undergo nephrectomy only. If they meet criteria, they are then observed periodically for 5 years. Patients with recurrent disease undergo surgery (immediate or delayed) and receive chemotherapy as in stratum III. Patients with no metachronous renal disease receive radiotherapy. Patients with metachronous disease undergo renal-sparing surgery and chemotherapy as in stratum III, but no radiotherapy. Treatment continues for up to 25 weeks. STRATUM II: (standard-risk, stage I or II disease with adverse biological marker) Patients undergo nephrectomy. Between 9 and 14 days post-nephrectomy, patients receive vincristine IV beginning on day 1, every week for 10 weeks then every 3 weeks for a total of 15 doses. Patients receive dactinomycin IV beginning day 1, alternating every 3 weeks with doxorubicin hydrochloride IV for a total of 5 doses of dactinomycin and 4 doses of doxorubicin. Treatment continues for up to 25 weeks. STRATUM III: (standard-risk, stage III disease) Patients undergo nephrectomy, if feasible, or biopsy. For patients who undergo biopsy only, definitive surgery is undertaken at week 7 or 13. Between 9 and 14 days post-nephrectomy, patients receive vincristine IV beginning on day 1 every week for 10 weeks then every 3 weeks for a total of 15 doses. Patients receive dactinomycin IV beginning day 1, alternating every 3 weeks with doxorubicin hydrochloride IV for a total of 5 doses of dactinomycin and 4 dose of doxorubicin hydrochloride. Patients undergo radiotherapy over 5-7 days after nephrectomy. Treatment continues for up to 25 weeks. Additionally, patients undergo chest X-ray, computed tomography (CT) or magnetic resonance imaging (MRI), ultrasound, echocardiography, and blood sample collection throughout the study. After completion of study treatment, patients are followed periodically for up to 8 years.
Source references
references
  1. citation
    Dix DB, Fernandez CV, Chi YY, Mullen EA, Geller JI, Gratias EJ, Khanna G, Kalapurakal JA, Perlman EJ, Seibel NL, Ehrlich PF, Malogolowkin M, Anderson J, Gastier-Foster J, Shamberger RC, Kim Y, Grundy PE, Dome JS; AREN0532 and AREN0533 study committees. Augmentation of Therapy for Combined Loss of Heterozygosity 1p and 16q in Favorable Histology Wilms Tumor: A Children's Oncology Group AREN0532 and AREN0533 Study Report. J Clin Oncol. 2019 Oct 20;37(30):2769-2777. doi: 10.1200/JCO.18.01972. Epub 2019 Aug 26.
    pmid
    31449468
    type
    DERIVED
  2. citation
    Fernandez CV, Mullen EA, Chi YY, Ehrlich PF, Perlman EJ, Kalapurakal JA, Khanna G, Paulino AC, Hamilton TE, Gow KW, Tochner Z, Hoffer FA, Withycombe JS, Shamberger RC, Kim Y, Geller JI, Anderson JR, Grundy PE, Dome JS. Outcome and Prognostic Factors in Stage III Favorable-Histology Wilms Tumor: A Report From the Children's Oncology Group Study AREN0532. J Clin Oncol. 2018 Jan 20;36(3):254-261. doi: 10.1200/JCO.2017.73.7999. Epub 2017 Dec 6.
    pmid
    29211618
    type
    DERIVED
  3. citation
    Fernandez CV, Perlman EJ, Mullen EA, Chi YY, Hamilton TE, Gow KW, Ferrer FA, Barnhart DC, Ehrlich PF, Khanna G, Kalapurakal JA, Bocking T, Huff V, Tian J, Geller JI, Grundy PE, Anderson JR, Dome JS, Shamberger RC. Clinical Outcome and Biological Predictors of Relapse After Nephrectomy Only for Very Low-risk Wilms Tumor: A Report From Children's Oncology Group AREN0532. Ann Surg. 2017 Apr;265(4):835-840. doi: 10.1097/SLA.0000000000001716.
    pmid
    27811504
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        tabindex="-1">Augmentation of therapy improves EFS for patients with FH Wilms tumor and loss of heterozygosity of 1p and 16q. In the <a href="/clinicaltrials/NCT00352534">AREN0532 (NCT00352534)</a> and <a href="/clinicaltrials/NCT00379340">AREN0533 (NCT00379340)</a> trials, patients with stage I and stage II FH Wilms tumor who
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      2. context exact
        tion of therapy improves EFS for patients with FH Wilms tumor and loss of heterozygosity of 1p and 16q. In the <a href="/clinicaltrials/NCT00352534">AREN0532 (NCT00352534)</a> and <a href="/clinicaltrials/NCT00379340">AREN0533 (NCT00379340)</a> trials, patients with stage I and stage II FH Wilms tumor who were treated with the D
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      3. context exact
        hildren younger than 2 years at diagnosis with stage I FH tumor that weighed &lt;550 g):</p> <p id="_975" tabindex="-1">In the <a href="/clinicaltrials/NCT00352534">AREN0532 (NCT00352534)</a> trial, the COG validated the findings from the <a href="/clinicaltrials/NCT00002611">NWTS-5</a> trial that nephrectomy only is app
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        years at diagnosis with stage I FH tumor that weighed &lt;550 g):</p> <p id="_975" tabindex="-1">In the <a href="/clinicaltrials/NCT00352534">AREN0532 (NCT00352534)</a> trial, the COG validated the findings from the <a href="/clinicaltrials/NCT00002611">NWTS-5</a> trial that nephrectomy only is appropriate therapy for pa
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        at diagnosis with stage I FH Wilms tumor that weighed less than 550 g.</p> <div class="pdq-content-list"><ol id="_977"><li>The <a href="/clinicaltrials/NCT00352534">AREN0532 (NCT00352534)</a> trial was designed to confirm the findings from NWTS-5 that adjuvant chemotherapy could be omitted for children younger than 2 year
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        I FH Wilms tumor that weighed less than 550 g.</p> <div class="pdq-content-list"><ol id="_977"><li>The <a href="/clinicaltrials/NCT00352534">AREN0532 (NCT00352534)</a> trial was designed to confirm the findings from NWTS-5 that adjuvant chemotherapy could be omitted for children younger than 2 years at diagnosis with st
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      Wilms Tumor and Other Childhood Kidney Tumors Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: April 15, 2025
        datetime
        2025-04-15T12:00:00Z
        display
        April 15, 2025

    Preserved source evidence · Not medical advice