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Anti-tumor antibiotic

Chemotherapy +/− Radiation for Kidney Cancer

Phase 3

Waitlist Available

Led By Conrad V Fernandez

Research Sponsored by Children's Oncology Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No prior tumor-directed chemotherapy or radiotherapy

Denys-Drash syndrome or other associated genito-urinary anomalies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is studying whether giving vincristine, dactinomycin, and doxorubicin with or without radiation therapy or observation only is effective in treating patients with Wilms' tumor.

Who is the study for?

This trial is for young patients who've had surgery for a newly diagnosed Wilms' tumor, which is a type of kidney cancer. It's open to those with stage I-III disease, under 30 years old, and without certain genetic syndromes or bilateral tumors. Patients must not be pregnant, should use contraception if fertile, and have not received prior tumor treatments.

What is being tested?

The study tests the effectiveness of chemotherapy drugs vincristine, dactinomycin, and doxorubicin after surgery. Some patients may also receive radiation therapy or just observation. The goal is to see if these treatments can eliminate any remaining cancer cells post-surgery.

What are the potential side effects?

Chemotherapy drugs like vincristine, dactinomycin, and doxorubicin can cause side effects such as nausea, hair loss, mouth sores, low blood cell counts increasing infection risk; while radiation might lead to skin irritation at the treatment site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have not had chemotherapy or radiotherapy for my tumor.

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I have Denys-Drash syndrome or similar urinary tract issues.

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My cancer is in the early stage (Stage I).

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I am under 2 years old.

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My heart's pumping ability is within a healthy range.

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My lymph nodes do not have cancer, confirmed by a biopsy.

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My cancer is in an early to mid-stage (I-III).

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I have aniridia.

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My tumor weighs less than 550 grams.

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I do not have Wilms tumors in both kidneys at the same time.

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I am between 2 and 29 years old.

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My genetic test shows no loss on chromosomes 1p and 16q.

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My child can do most activities but may need assistance.

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My condition is at stage III.

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I have Beckwith-Wiedemann syndrome.

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My condition does not need radiation treatment.

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I have been diagnosed with Simpson-Golabi-Behmel syndrome.

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My early-stage cancer shows specific genetic changes.

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My condition is at stage II.

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I do not have a high-risk genetic condition for kidney cancer.

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My condition is confirmed as Wilms' tumor.

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I have a unilateral Wilms tumor without risk factors for developing it on both sides.

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My child under 1 year has a specific kidney condition.

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I am younger than 30 years old.

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My condition needs radiation treatment.

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I am over 16 and can do most activities without help.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Event Free Survival Probability

Overall Survival (OS) Probability

Secondary study objectives

Incidence of Contralateral Kidney Lesions

Incidence of Renal Failure

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Stratum III (standard-risk, stage III)Experimental Treatment11 Interventions

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.

Group II: Stratum II (standard-risk, stage I or II)Experimental Treatment11 Interventions

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.

Group III: Stratum I (very low-risk disease)Experimental Treatment11 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Therapeutic Conventional Surgery

2005

Completed Phase 3

~9890

Doxorubicin Hydrochloride

2019

Completed Phase 3

~17860