NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: C000000239

Registered date:16/09/2005

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedUterine cervical cancer
Date of first enrollment2003/03/01
Target sample size18
Countries of recruitmentJapan
Study typeInterventional
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 OutcomeAdverse events Feasibility Response rate
Secondary OutcomeProgression free survival Overall survival

Key inclusion & exclusion criteria

Age minimum16years-old
Age maximum75years-old
GenderFemale
Include criteria
Exclude criteria1) 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

Contact

public contact
Name Kimihiko Ito
Address 3-1-69 Inabaso, Amagasaki, Hyogo, Japan Japan
Telephone 06-6416-1221
E-mail kimihiko-ito@kanrou.net
Affiliation Kansai Rosai Hospital Obstetrics and Gynecology
scientific contact
Name Kimihiko Ito
Address 3-1-69 Inabaso, Amagasaki, Hyogo, Japan Japan
Telephone 06-6416-1221
E-mail
Affiliation Kansai Rosai Hospital Obstetrics and Gynecology