A phase I/II study of concurrent chemoradiotherapy with irinotecan for advanced or recurrent uterine cancer
- Conditions
- uterine cancer (squamous cell carcinoma, adeno- and/or adenosquamous cell carcinoma, endometrial carcinoma, carcinosarcoma)
- Registration Number
- JPRN-C000000148
- Lead Sponsor
- ational Hospital Organization Kobe Medical Center
- Brief Summary
The status of the recruiting patients and chief adverse events were reported at the meeting of the Japanese Foundation for Multidisciplinary Treatemtn of Cancer and the International Gyneclogical Cancer Society held on last Novenmber. Now the recruiting was finished. At DL4, two patients out of three revealed dose limitting adverse events. MTD was decided as a dose level 4, ie, 60mg/sqm.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 18
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method