|
| Overall Recruitment Status: Enrollment complete |
| |
| Official Title |
| 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 |
| |
| Region |
Sponsors |
| California - Northern |
|
| |
| Acronym |
NCT No. |
|
NCT00352534 |
| |
| Study Type |
Phase |
| INTERVENTIONAL |
|
| |
| Purpose |
| 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. Radiation therapy uses high-energy x-rays to kill tumor cells. 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 |
| This is a multicenter study. Patients are stratified into three groups 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. After completion of study treatment, patients are followed periodically for up to 8 years. |
| |
| |
| |
- Karnofsky performance status (PS) 50-100% for patients > 16 years old
|
-
AST or ALT < 2.5 times ULN,
Shortening fraction greater than or equal to 27% by echocardiogram OR ejection fraction greater than or equal to 50% by radionuclide angiogram (standard-risk disease),
Negative pregnancy test,
Fertile patient must use effective contraception,
Patients transferring from study AREN03B2 with LOH 1p and 16q allowed,
Please contact study team for additional inclusion criteria,
|
|
| |
- Moderate- or high-risk Wilms' predisposition syndromes,
Bilirubin (direct) > or = 1.5 times upper limit of normal (ULN),
Pregnant or nursing,
Prior tumor-directed chemotherapy or radiotherapy,
Please contact study team for additional exclusion criteria,
|
|
| |
- National Cancer Institute
|
|
|
|
|
|
|
|
|
|
-
therapeutic conventional surgery
|
-
doxorubicin hydrochloride
|
|
-
external beam radiation therapy
|
|
|
| |
|