Comparison of Radiation Therapy With or Without Combination Chemotherapy Following Surgery in Tre… (NCT00006027) | Clinical Trial Compass
CompletedPhase 3
Comparison of Radiation Therapy With or Without Combination Chemotherapy Following Surgery in Treating Patients With Stage I or Stage II Endometrial Cancer
United StatesStarted 2000-08
Plain-language summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor tissue. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if radiation therapy is more effective with or without combination chemotherapy for endometrial cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without combination chemotherapy following surgery in treating patients who have stage I or stage II endometrial cancer.
Who can participate
Age range18 Years – 120 Years
SexFEMALE
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DISEASE CHARACTERISTICS:
* Histologically confirmed uterine confined endometrioid endometrial adenocarcinoma with one of the following:
* Grade 2 or 3 carcinoma with more than 50% myometrial invasion (stage IC and IIA)
* Grade 2 or 3 carcinoma with stromal invasion of the cervix (stage IIB)
* No grade I adenocarcinoma
* Less than 50% papillary serous or clear cell histology on pathologic specimen
* Prior hysterectomy (total abdominal, vaginal hysterectomy, or laparoscopic-assisted vaginal hysterectomy) and bilateral salpingo-oophorectomy with or without additional surgical staging for endometrial cancer no more than 8 weeks prior to study
* No known metastatic extrauterine metastases, known gross residual disease, positive peritoneal cytology, or distant metastases
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Zubrod 0-1
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count at least 1,800/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 10 g/dL
Hepatic:
* Bilirubin no greater than 1.5 times normal
* SGOT no greater than 3 times normal
Renal:
* Creatinine no greater than 1.5 mg/dL
Cardiovascular:
* No cardiac dysrhythmias
Other:
* No other malignancy within the past 5 years except nonmelanomatous skin cancer
* No medical contraindications to study therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy
Endocrine therapy:
* Not specified
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