Clinical Trials

Carboplatin and Paclitaxel With or Without Cisplatin and Radiation Therapy in Treating Patients With Stage I, Stage II, Stage III, or Stage IVA Endometrial Cancer

Location:

Trial status:

Open for Enrollment

Why is this study being done?

OBJECTIVES:

Primary

- Compare the recurrence-free survival of patients with stage I-IVA endometrial carcinoma treated with adjuvant chemoradiotherapy comprising cisplatin and tumor volume-directed radiotherapy followed by carboplatin and paclitaxel vs carboplatin and paclitaxel alone.

Secondary

- Compare the overall survival of patients treated with these regimens.

- Compare the acute and late adverse effects of these regimens in these patients.

- Determine the impact of these regimens on patient-reported quality of life during and for up to 1 year after completion of study treatment.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive cisplatin IV on days 1 and 29. 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.

- Arm 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.

Patients complete quality-of-life questionnaires at baseline and periodically during study using the FACT-G Physical and Functional Well-Being, FACT-Endometrial, FACT/GOG Neuropathy, and FACT-C (items C3 and C5).

After completion of study therapy, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Who is eligible to participate?

DISEASE CHARACTERISTICS:

- Histologically confirmed endometrial carcinoma, including the following cell types:

- Clear cell carcinoma

- Serous papillary carcinoma

- Undifferentiated carcinoma

- Surgical stage III or IVA disease per FIGO 2009 staging criteria

- Surgical stage III disease includes positive adnexa, tumor invading the serosa, positive pelvic and/or para-aortic nodes, or vaginal involvement

- Surgical stage IVA disease includes bladder or bowel mucosal involvement, but no spread outside the pelvis

- Surgical stage I or II endometrial clear cell or serous papillary carcinoma with positive peritoneal cytology per FIGO 2009 staging criteria

- Has undergone optimal surgical debulking that included a hysterectomy and bilateral salpingo-oophorectomy within the past 8 weeks

- Residual tumor after surgery (any single site) ≤ 2 cm in maximum dimension

- No carcinosarcoma

- No parenchymal liver metastases

- No recurrent endometrial cancer or endometrioid stage I or II with positive peritoneal cytology

PATIENT CHARACTERISTICS:

- GOG performance status 0-2

- Life expectancy ≥ 3 months

- WBC ≥ 3,000/mm^3

- ANC ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN)

- Alkaline phosphatase ≤ 2.5 times ULN

- Bilirubin ≤ 1.5 times ULN

- Creatinine ≤ ULN

- No myocardial infarction, unstable angina, or uncontrolled arrhythmia within the past 3 months

- No other active invasive malignancy within the past 5 years except for non-melanoma skin cancer

- No history of serious co-morbid or uncontrolled illness that would preclude study therapy

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior pelvic or abdominal radiotherapy

- No prior chemotherapy for endometrial cancer

- No prior cancer treatment that would preclude study therapy

Last updated: 03/26/2012

NCT ID: NCT00942357

IRB Number:09-004924