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

PhaseI/II trial of chemotherapy with docetaxel, CDDP and 5-Fluorouracil followed by chemoradiotherapy with CDDP and 5-Fluorouracil in patients with locally advanced esophageal cancer. - PhaseI/II trial of induction chemotherapy with DCF and definite chemoradiotherapy with FP in patients with locally advanced esophageal cancer.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003546

Enrollment

Registered

2010-05-01

Start date

2010-05-01

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

Induction chemotherapy Combination chemotherapy consists of docetaxel (25,30,35,40 mg/m2/day, day 1,15,29 and day 43), cisplatin (70 mg/m2/day, day 1,29), and 5-FU (700mg/m2/day, days 1 through 4 and

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Histologically proven esophageal carcinoma. 2.Lesion located within the radiation field. 3. Locally advanced inoperable esophageal cancer excluding distant metastasis. (StageIII-IVa(UICC)) 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

Measure	Time frame
PhaseI: Incidence of dose limiting toxicity PhaseII: Clinical response rate	—

Secondary

Measure	Time frame
PhaseI: Adverse events, Clinical response rate PhaseII: Adverse events, Progression-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