Chemotherapy +/− Radiation for Kidney Cancer

Recruiting in Palo Alto (17 mi)

+319 other locations

Overseen byElizabeth A Mullen

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Children's Oncology Group

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Elizabeth A Mullen

Principal Investigator

Children's Oncology Group

Eligibility Criteria

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.

Inclusion Criteria

My tumor has a measurable weight.

My condition fits into one of the required disease categories.

I have not had chemotherapy or radiotherapy for my tumor.

See 38 more

Treatment Details

Interventions

3-dimensional conformal radiation therapy (Radiation)
3-Dimensional Conformal Radiation Therapy (Radiation)
Dactinomycin (Anti-tumor antibiotic)
Doxorubicin Hydrochloride (Anti-tumor antibiotic)
Therapeutic Conventional Surgery (Procedure)
Vincristine Sulfate (Vinca alkaloids)

Trial OverviewThe 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.

Participant Groups

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.

Dactinomycin is already approved in Canada for the following indications: