A phase I/II study of docetaxel, nedaplatin and 5-fluorouracil with concurrent radiotherapy(DNF-R) in patients with esophageal cancer

A phase I/II study of docetaxel, nedaplatin and 5-fluorouracil with concurrent radiotherapy(DNF-R) in patients with esophageal cancer - A phase I/II study of DNF-R in patients with esophageal cancer

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005446

Enrollment

Registered

2011-04-14

Start date

2011-04-01

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

Chemotherapy of docetaxel, nedaplatin and 5-fluorouracil with concurrent radiotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) histologically proven esophageal cancer; (2) clinical stage I to IV A (UICC-TMN)(phase I) (3) an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. (4) age 20; 78 years; (5) adequate baseline bone marrow function, adequate hepatic function adequate renal function, adequate respiratory and cardiac function. (6) a life expectancy of at least 3 months. (7) Written informed consent was obtained from all patients.

Exclusion criteria

Exclusion criteria: (1) No prior chemotherapy regimen. (2) history of drug hypersensitivity. (3) active concomitant malignancy. (4) serious complications (severe heart disease, active infection) (5) pregnant or lactating females. (6) The investigator considers not suitable for the study.

Design outcomes

Primary

Measure	Time frame
Phase I To determine the recommended dose (RD) Phase II Safety, Tumor responses	—

Countries

Japan

Contacts

Public ContactYasushis Sato

Sapporo Medical University School of Medicine Dept. of Internal Medicine(4)

yasushis@sapmed.ac.jp011-611-2111

Outcome results

None listed

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