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PhaseI/II trial of neoadjvant chemoradiotherapy with docetaxel,CDDP and 5-Fluorouracil followed by surgery in patients with advanced esophageal cancer.

PhaseI/II trial of neoadjvant chemoradiotherapy with docetaxel,CDDP and 5-Fluorouracil followed by surgery in patients with advanced esophageal cancer. - PhaseI/II trial of neoadjvant chemoradiotherapy with DCF in patients with advanced esophageal cancer.

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000002137
Enrollment
40
Registered
2009-08-01
Start date
2009-08-01
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 Cancer

Interventions

Radiotherapy(2Gy/5day/week) is begun within 24 hours of the administration of chemotherapy, and continue for 4 weeks(40Gy). Combination chemotherapy consists of docetaxel (25,30,35,40 mg/m2/day, day

Sponsors

Department of Surgical Oncology, Division of Clinical and Experimental Oncology, Research Institute for Radiation Biology and Medicine, Hiroshima University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Histologically proven esophageal carcinoma. 2.Lesion located within the radiation field. 3.Primary lesion with penetration of muscularis propiria, excluding T4 lesion and distant metastasis. 4.Measurable lesion 5.No previous therapy against esophageal cancer. 6.No previous radiotherapy within the radiation field. 7.ECOG Performance status 0 or 1 8.Aged 20 to 75 years old 9.Expected to survive more than 3 months 10.Written informed consent

Exclusion criteria

Exclusion criteria: 1.History of hypersensitivity to DOC, CDDP, 5-FU, or polysorbate 80 2.With severe complication 3.Infection with fever elevation 4.Motor paralysis, peripheral neuropathy or edema 5.Pleural or pericardial effusion that requires treatment 6.Simultaneous or metachronous (within 5 years) double cancers. 7.Pregnant or lactating women 8.Interstitial pneumonia or fibroid lung 9.Psychosis

Design outcomes

Primary

MeasureTime frame
PhaseI:Incidence of dose limiting toxicity PhaseII:Histopathological response rate

Secondary

MeasureTime frame
PhaseI:Adverse events,Histopathological response rate PhaseII:Adverse events, Disease-free survival, Overall survival

Countries

Japan

Contacts

Public ContactManabu Emi

Research Institute for Radiation Biology and Medicine Hirosima University Surgical Oncology

moaista@hotmail.com082-257-5869

Outcome results

None listed

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