GOG 258: A Randomized Phase III Trial of Cisplatin and Tumor Volume Directed Irradiation Followed by Carboplatin and Paclitaxel vs. Carboplatin and Paclitaxel for Optimally Debulked, Advanced Endometrial Carcinoma

Summary

This two-arm, open-label, randomized phase iii trial is studying carboplatin and paclitaxel to see how well they work when given with or without cisplatin and radiation therapy in treating patients with stage iii or stage iVa endometrial cancer.

* Regimen i: Patients receive cisplatin iV on days 1 and 28. Patients also undergo external-beam radiotherapy once daily, 5 days a week, for 5-6 weeks. Some patients may then undergo brachytherapy over 2-3 weeks. Beginning within 8 weeks after completion of chemoradiotherapy, patients receive paclitaxel iV over 3 hours and carboplatin iV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

* Regimen ii: Patients receive paclitaxel iV over 3 hours and carboplatin iV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity

note that carboplatin dose will be recalculated if patient has weight change of greater than or equal to 10% from baseline.

Participant Eligibility

Criteria for inclusion of Subjects:
1.All patients with FIGO Surgical Stage III or IVA endometrial carcinoma, including clear cell and serous papillary and undifferentiated carcinomas.
2.Surgical Stage III disease includes those patients with positive adnexa, tumor invading the serosa, positive pelvic and/or para-aortic nodes, or vaginal involvement. Patients with positive pelvic washings as the only extra-uterine disease are eligible only if the histology is clear cell or serous papillary.
3.Surgical Stage IVA includes patients with bladder or bowel mucosal involvement, but no spread outside the pelvis.
4.Surgery must have included a hysterectomy and bilateral salpingooophorectomy. Pelvic lymph node sampling and para-aortic lymph node sampling are optional.
5.Patients with a GOG Performance Status of 0, 1, or 2.
6.Patients with adequate organ function, reflected by the following parameters:
WBC >= 3000/mcl
Absolute neutrophil count (ANC) >= 1500/mcl
Platelet count >= 100,000/mcl
SGOT, SGPT, and alkaline phosphatase <= 2.5 X normal.
Bilirubin <= 1.5 X normal
Creatinine <= 1.6 mg/dl
7.Patients who have met the pre-entry requirements specified in Section 7.0; testing values/results must meet eligibility criteria specified in Section 3.1.
8.Patients who have signed an approved informed consent and authorization permitting release of personal health information.
9.Patients must be 18 years of age or older.
10.Female patients of all ethnic and racial groups.
11.Spanish speaking patients