Status:
COMPLETED
Whole-Abdominal Radiation Therapy and Cisplatin in Treating Patients With Stage III or Stage IV Endometrial Cancer That Has Been Removed by Surgery
Lead Sponsor:
University of Miami
Conditions:
Endometrial Cancer
Eligibility:
FEMALE
18-80 years
Phase:
PHASE1
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy use...
Detailed Description
OBJECTIVES: * Determine a recommended phase II dose of adjuvant whole-abdominal radiotherapy when administered with cisplatin in patients with optimally debulked stage III or IV carcinoma of the endo...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of endometrial cancer, including any of the following cellular types:
- Papillary serous carcinoma
- Clear cell carcinoma
- Adenocarcinoma
- Stage III or IV disease
- No evidence of extra-abdominal extension of disease (e.g., groin nodes, lung, or supraclavicular nodes)
- Has undergone total-abdominal hysterectomy, surgical removal of any present fallopian tube and ovary, and resection of any palpable lymph nodes in the pelvis and para-aortic region (or surgical sampling of these nodal regions if no palpable nodes were present) within the past 6 weeks
- Peritoneal washings must have been collected for cytological evaluation
- Must have ≤ 1 cm residual disease after surgery
- PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- Life expectancy ≥ 6 months
- WBC ≥ 3,000/mm\^3
- Granulocyte count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Creatinine \< 2.0 mg/dL
- Bilirubin \< 1.5 times upper limit of normal (ULN)
- Lactate dehydrogenase \< 3 times ULN
- Gamma glutamyl transferase \< 3 times ULN
- SGPT and SGOT \< 3 times ULN
- Alkaline phosphatase \< 3 times ULN
- No other malignant tumor within the past 5 years
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior radiotherapy to the whole abdomen and/or pelvis/vagina
- No systemic chemotherapy within the past 5 years
Exclusion
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00448643
Start Date
May 1 2002
End Date
March 1 2011
Last Update
December 15 2016
Active Locations (1)
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1
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136