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)

UMIN ID: C000000335

Registered date:21/02/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: uterine cervical neoplasms
• Date of first enrollment: 2006/02/01
• Target sample size: 250
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

A: chemotherapy:Paclitaxel/Cisplatin
B: chemotherapy:Paclitaxel/Carboplatin

Outcome(s)

• Primary Outcome: overall survival
• Secondary Outcome: progression-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 minimum: 20years-old
• Age maximum: 75years-old
• Gender: Female
• Exclude criteria: 1) 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

• Primary Sponsor: Japan Clinical Oncology Group(JCOG)
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare