Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer
Completed · Phase 1
Conditions studied: Endometrial Adenocarcinoma, Endometrial Clear Cell Adenocarcinoma, Endometrial Serous Adenocarcinoma, Stage III Uterine Corpus Cancer, Stage IV Uterine Corpus Cancer
In brief
Phase I trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating women who have stage III or stage IV endometrial cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.
Key facts
- Study ID
- NCT00005830
- Run by
- Gynecologic Oncology Group
- People needed
- 31
- Starts
- 2000-07-01
- Last updated by the study team
- 2014-12-31
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed endometrial cancer including 1 of the following subtypes:
- Clear cell carcinoma
- Serous papillary carcinoma
- Endometrioid adenocarcinoma
- Stage III or IV disease
- Positive adnexa
- Metastases to serosa, bowel mucosa, abdomen
- Positive pelvic or paraaortic nodes
- Positive pelvic washings or vaginal involvement within the radiation port
- Tumor must be surgically reduced to 2 cm or less within 8 weeks of study entry
- Must have had a hysterectomy and bilateral salpingo oophorectomy
- No recurrent disease
- No distant metastases outside of abdominopelvic area, including:
- Parenchymal liver metastases
- Lung metastases
- Positive inguinal lymph nodes
- Positive supraclavicular nodes
- Pleural effusion with malignant cytology
- Performance status - GOG 0-2
- Absolute neutrophil count at least 1,500/mm\^3
- Platelet count at least 100,000/mm\^3
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- SGOT and alkaline phosphatase no greater than 3 times ULN
- Creatinine no greater than ULN
- Cardiac ejection fraction greater than 50%
Where it is running
- Gynecologic Oncology Group — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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