Phase I/II study of docetaxel, CDDP and 5-FU therapy in patients with unresectable or recurrent esophageal cancer (JCOG 0807)

UMIN ID: UMIN000001737

Registered date:27/02/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: esophageal neoplasm
• Date of first enrollment: 2009/02/01
• Target sample size: 64
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Combination chemotherapy consists of docetaxel (30 or 40 mg/m2/day, day 1 and day 15), cisplatin (80 mg/m2/day, day 1), and 5-FU (800mg/m2/day, days 1 through 5). The treatment is repeated every 4 weeks until obvious evidence of disease progression, patient refusal, or unacceptable toxicity.

Outcome(s)

• Primary Outcome: Phase I: Incidence of dose limiting toxicity Phase II: Response rate
• Secondary Outcome: Phase I: Adverse events, Response rate. Phase II: Overall survival, Progression-free survival, Adverse events

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1) Uncontrollable diabetes mellitus or administration of insulin. 2) Simultaneous or metachronous (within 5 years) double cancers. 3) History of hypersensitivity to DOC, CDDP, 5-FU, or polysorbate 80 4) Active bacterial or fungous infection. 5) Systemic steroids medication 6) Motor paralysis or peripheral neuropathy by any reason 7) Edema by any reason 8) Interstitial pneumonia or fibroid lung 9) Psychosis 10) Pregnant or lactating women

Related Information

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