A prospective open-randomized controlled trial comparing postoperative chemoradiotherapy versus chemotherapy for cervical cancer patients with lymph node metastases.

UMIN ID: C000000076

Registered date:01/04/2010

Basic Information

• Health condition(s) or Problem(s) studied: Patients who had radical hysterectomy for stage IB-IIB cervical cancer, and were certified to have lymph node mestastases histologocally after radical surgery. Patients with only squamous cell carcinoma were eligible.
• Date of first enrollment: 2005/02/01
• Target sample size: 170
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Concurrent chemoradiotherapy (Group A) Whole pelvic irradiation (50 Gy) and CDDP 70mg/m2, each 4 week, 3 times.
Chemotherapy (Group B) CDDP 70mg/m2, each 4 week, 3 times.

Outcome(s)

• Primary Outcome: Recurrent rata including distant metastases.
• Secondary Outcome: Late adverse effect Survival

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1. Past history of pelvic surgery (except appendectomy). 2. past history of pelvic irradiation. 3. Positive surgical margin, or positive paraaortic lymph nodes. 4. Estimaated survival is less than 6 months. 5. Renal dysfunction. 6. Acitve infection (Tuberculosis or mycosis) in the pelvis. 7. Active double cancer. 8. Otehr reasons that is not eligible to this trial.

Related Information

• Primary Sponsor: Study Group of Postoperative radiotherapy for cervical cancer.
• Secondary Sponsor: none
• Source(s) of Monetary Support: Grant of Ministry of Health, Labour and Welfare,none