Comparison of Two Combination Chemotherapy Regimens Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer
Completed · Phase 3
Conditions studied: Endometrial Adenocarcinoma, Endometrial Adenosquamous Carcinoma, Endometrial Clear Cell Adenocarcinoma, Endometrial Endometrioid Adenocarcinoma, Variant With Squamous Differentiation, Endometrial Serous Adenocarcinoma, Stage III Uterine Corpus Cancer
In brief
Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens plus radiation therapy in treating patients who have stage III or stage IV endometrial cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells. It is not yet known which combination chemotherapy regimen plus radiation therapy is more effective for endometrial cancer.
Key facts
- Study ID
- NCT00006011
- Run by
- Gynecologic Oncology Group
- People needed
- 659
- Starts
- 2000-07-01
- Last updated by the study team
- 2015-05-19
Who can join
Age: any. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed advanced endometrial carcinoma with any histology, including:
- Clear cell and serous papillary carcinoma
- Surgical stage III disease, including:
- Positive adnexa
- Tumor invading the serosa
- Positive pelvic and/or paraaortic nodes
- Involvement of bowel mucosa
- Intraabdominal metastases
- Positive pelvic washings
- Vaginal involvement within the radiation port
- Must have had prior surgery, including hysterectomy and bilateral salpingo-oophorectomy
- Tumor maximally debulked to a maximum residual diameter of no greater than 2 cm
- Paraaortic lymph node sampling allowed
- If positive, must have negative chest CT scan
- No recurrent disease
- No parenchymal liver metastases
- No disease outside the abdomen
- Performance status - GOG 0-2
- At least 3 months
- Absolute neutrophil count at least 1,500/mm\^3
- Platelet count at least 100,000/mm\^3
- Bilirubin no greater than 1.5 times normal
- SGOT/SGPT no greater than 3 times normal
- Alkaline phosphatase no greater than 3 times normal
- Creatinine no greater than 1.6 mg/dL
Where it is running
- Gynecologic Oncology Group — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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