NIPH Clinical Trials Search

UMIN ID: UMIN000001737

Registered date:27/02/2009

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedesophageal neoplasm
Date of first enrollment2009/02/01
Target sample size64
Countries of recruitmentJapan
Study typeInterventional
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.


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

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum75years-old
GenderMale and Female
Include criteria
Exclude criteria1) 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


public contact
Name Shuichi Hironaka
Address 666-2, Nitonatyo, Chuo-ku,Chiba city ,Chiba Pref 260-8717, Japan. Japan
Telephone 043-264-5431
Affiliation JCOG0807 Coordinating Office Division of Gastrointestinal Oncology
scientific contact
Name Yasuhiro Tsubosa
Address 1007, Shimonagakubo, Nagaizumi-Chou, Sunto-Gun, Shizuoka 411-8777, Japan. Japan
Affiliation Shizuoka Cancer Center Division of Esophageal Surgery