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

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001737

Enrollment

Registered

2009-02-27

Start date

2009-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

esophageal neoplasm

Interventions

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 wee

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Lesion mainly located in the cervical or thoracic esophagus 2) Histologically proven squamous cell carcinoma, adenosquamous caricinoma , or adenocarcinoma 3) Unresectable or recurrent esophageal cancer with no indication for surgery, radiotherapy, and chemoradiotherapy 4) Aged 20 to 75 years old 5) ECOG Performance status 0 or 1 6) Measurable lesion 7) Neither previous chemotherapy, chemoradiotherapy, nor radiotherapy against any cancer 8) Adequate organ functions 9) Without symptomatic brain metastasis 10) Without moderate or more ascites/pleural effusion 11) Written informed consent

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Phase I: Incidence of dose limiting toxicity Phase II: Response rate	—

Secondary

Measure	Time frame
Phase I: Adverse events, Response rate. Phase II: Overall survival, Progression-free survival, Adverse events	—

Countries

Japan

Contacts

Public ContactShuichi Hironaka

JCOG0807 Coordinating Office Division of Gastrointestinal Oncology

043-264-5431

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026