NCT00352534|Active Not RecruitingPhase 3ResultsDMC

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

Treatment for Very Low and Standard Risk Favorable Histology Wilms Tumor

Children's Oncology Group ClinicalTrials.gov

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6 other identifiers

AREN0532NCI-2009-0106706-936CDR0000487540U10CA098543U10CA180886

Study Type

interventional

Target

808

Locations

7 countries

Sites

240

Timeline

RegisteredJul 2006

StartedNov 2006

CompletionMar 2026

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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

808

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Nov 2006

Longer than P75 for phase_3

Geographic Reach

7 countries

240 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

19.4 years study duration

First Submitted

Initial submission to the registry

July 13, 2006

Completed

1 day until next milestone

First Posted

Study publicly available on registry

July 14, 2006

Completed

4 months until next milestone

Study Start

First participant enrolled

November 6, 2006

Completed

8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2014

Completed

2.4 years until next milestone

Results Posted

Study results publicly available

May 15, 2017

Completed

8.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed

Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

8.2 years

First QC Date

July 13, 2006

Results QC Date

October 26, 2016

Last Update Submit

February 4, 2026

Conditions

Stage I Kidney Wilms Tumor Stage II Kidney Wilms Tumor Stage III Kidney Wilms Tumor

Outcome Measures

Primary Outcomes (2)

Event Free Survival Probability
Probability of no relapse, secondary malignancy, or death after 4 year in the study.
4 years
Overall Survival (OS) Probability
Probability of being alive after 4 years in the study.
4 years

Secondary Outcomes (2)

Incidence of Contralateral Kidney Lesions
During follow-up
Incidence of Renal Failure
During follow-up

Study Arms (3)

Stratum I (very low-risk disease)

EXPERIMENTAL

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.

Radiation: 3-Dimensional Conformal Radiation TherapyProcedure: Biospecimen CollectionProcedure: Chest RadiographyProcedure: Computed TomographyBiological: DactinomycinDrug: Doxorubicin HydrochlorideProcedure: Echocardiography TestProcedure: Magnetic Resonance ImagingProcedure: Therapeutic Conventional SurgeryProcedure: Ultrasound ImagingDrug: Vincristine Sulfate

Stratum II (standard-risk, stage I or II)

EXPERIMENTAL

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.

Stratum III (standard-risk, stage III)

EXPERIMENTAL

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.