NIPH Clinical Trials Search

UMIN ID: C000000335

Registered date:21/02/2006

A Randomized Phase III trial of Paclitaxel plus Cisplatin versus Paclitaxel plus Carboplatin in Stage IVB, Persistent, or Recurrent Cervical Cancer (JCOG0505, CC-TPTC-P3)

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studieduterine cervical neoplasms
Date of first enrollment2006/02/01
Target sample size250
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)A: chemotherapy:Paclitaxel/Cisplatin B: chemotherapy:Paclitaxel/Carboplatin


Primary Outcomeoverall survival
Secondary Outcomeprogression-free survival, response rate, adverse events, severe adverse events, proportion of periods of non-hospitalization to those of the planned treatment

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum75years-old
Include criteria
Exclude criteria1) patients who have some neurologically functional disorder 2) symptomatic CNS metastasis 3) hypersensitive to alcohol 4) active infection 5) HBs antigen positive 6) uncontrollable hypertension 7) history of myocardiac infarction within six months 8) unstable angina 9) uncontrollable diabetes 10) Patients with a concomitant or prior invasive malignancy (except intramucosal malignancy which are curable with local therapy) who have had any evidence of the disease within the last 5 years 11) women during pregnancy or breast-feeding 12) patients with psychiatric liiness 13) patients who have been treated with the systemic steroids medication

Related Information


public contact
Name Ryo Kitagawa
Address 5-9-2 Higashi-gotanda, Shinagawa-ku, Tokyo, 141-0022, Japan Japan
Telephone 03-3448-6111
Affiliation JCOG0505 Coordinating Office Kanto Medical Center, NTT EC
scientific contact
Name Toshiharu Kamura
Address 67 Asahi-machi, Kurume 830-0011, Japan Japan
Affiliation Kurume University School of Medicine Department of Obstetrics and Gynecology