RANDOMIZED PHASE III CLINICAL TRIAL OF ADJUVANT RADIATION VERSUS CHEMORADIATION IN INTERMEDIATE RISK, STAGE I/IIA CERVICAL CANCER TREATED WITH INITIAL RADICAL HYSTERECTOMY AND PELVIC LYMPHADENECTOMY
- Conditions
- INTERMEDIATE RISK, STAGE I/IIA CERVICAL CANCER TREATED WITH INITIAL RADICAL HYSTERECTOMY AND PELVIC LYMPHADENECTOMY
- Registration Number
- JPRN-UMIN000004550
- Lead Sponsor
- RG Oncology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 360
Not provided
1) Patients with tumor in the parametria, pelvic lymph nodes or any other extra uterine site or with positive surgical margins. 2) Patients with septicemia or severe infection. 3) Patients with intestinal obstruction or gastrointestinal bleeding. 4) Patients with postoperative fistula. 5) Patients with cervix cancer who have received any previous radiation or chemotherapy. 6) Patients whose circumstances do not permit completion of the study or the required follow-up. 7) Patients with renal abnormalities requiring modification of radiation field (pelvic kidney, renal transplant, etc). 8) Patients with GOG Performance Status of 3 or 4. 9) Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method recurrence-free survival
- Secondary Outcome Measures
Name Time Method overall survival, adverse events