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

UMIN ID: C000000239

Registered date:16/09/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Uterine cervical cancer
• Date of first enrollment: 2003/03/01
• Target sample size: 18
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Patients receive radiotherapy and intravenous administration of CPT-11 and CDDP once a week, simultaneously. Traetment repeats weekly for 5 courses in the absence of unacceptable toxicity.

Outcome(s)

• Primary Outcome: Adverse events Feasibility Response rate
• Secondary Outcome: Progression free survival Overall survival

Key inclusion & exclusion criteria

• Age minimum: 16years-old
• Age maximum: 75years-old
• Gender: Female
• Exclude 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.

Related Information

• Primary Sponsor: Kansai Clinical Oncology Group (KCOG)
• Source(s) of Monetary Support: Kansai Clinical Oncology Group (KCOG)