A phase I/II study of concurrent chemoradiotherapy with irinotecan for advanced or recurrent uterine cancer

UMIN ID: C000000148

Registered date:09/09/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: uterine cancer (squamous cell carcinoma, adeno- and/or adenosquamous cell carcinoma, endometrial carcinoma, carcinosarcoma)
• Date of first enrollment: 2002/08/01
• Target sample size: 18
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): In chemoradiotherapy with Irinotecan (CPT-11), the determination of its maximum torelated dose and/or recommended dose and the estimation of its effecacy for advanced/recurrent uterine cancer.

Outcome(s)

• Primary Outcome: adverse events feasibility response
• Secondary Outcome: progression free survival overall survival

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Female
• Exclude criteria: Exclusion criteria (1)the patients with prior radiotherapy whose treatment area of irradiation will be overlaid to ex-treatment area (2)co-existence of active other malignancies (3)severe complications, such as a)infections, diarrhea (watery), ileus, interstistial pneumonitis, lung fibrosis b)too much pleural effusion, ascitic or abdominal ascites c)uncontrollable diabetis mellitus d)other complications which suffer from progressing study (4) pregnant or expected to be pregnant and breast feeding mother (5)known severe hypersensitivity to agent (6)whom the investigator think unappropriate as a candidate

Related Information

• Primary Sponsor: National Hospital Organization Kobe Medical Center
• Secondary Sponsor: Kansai Rosai Hospital, Nara prefectural Nara Hospital, Kyoto Medical College, Mie University,Nara prefectural Nara Medical college
• Source(s) of Monetary Support: Kansai Clinical Oncology Group (KCOG),Japanese Foundation for Multidisciplinary Treatment of Cancer