A phase I/II study of concurrent chemoradiation with irinotecan hydrochloride(CPT-11) and cisplatin(CDDP) for uterine cervical cancer. (KCOG 0328)

Phase 1

• Conditions: terine cervical cancer

• Registration Number: JPRN-C000000239
• Lead Sponsor: Kansai Clinical Oncology Group (KCOG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-16
• Study Completion: 2006-12-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Female
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

1) Severe complications: a) infections, diarrhea (watery), ileus, interstistial pneumonitis, lung fibrosis, b) massive pleural effusion or ascites, c) uncontrollable diabetes mellitus, d) other complications which suffer from progressing study. 2) Co-existence of active other malignancies. 3) The patients with prior radiotherapy whose treatment area of irradiation will be overlaid to ex-treatment area. 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
Adverse events Feasibility Response rate

Secondary Outcome Measures

Name	Time	Method
Progression free survival Overall survival