A phase II study of definitive chemoradiation therapy using docetaxel, nedaplatin, and 5-fluorouracil with modified dose radiation (mDNF-R) followed by S-1 maintenance therapy and salvage therapy for patients with clinical stage IB-IIIC (non-T4) esophageal carcinoma

A phase II study of definitive chemoradiation therapy using docetaxel, nedaplatin, and 5-fluorouracil with modified dose radiation (mDNF-R) followed by S-1 maintenance therapy and salvage therapy for patients with clinical stage IB-IIIC (non-T4) esophageal carcinoma - A phase II study of mDNF-R followed by S-1 maintenance therapy and salvage therapy for patients with esophageal carcinoma

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000025109

Enrollment

Registered

2016-12-01

Start date

2016-08-01

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 carcinoma

Interventions

Definitive chemoradiation therapy using docetaxel, nedaplatin and 5-fluorouracil (DNF) with concurrent radiotherapy (50.4 Gy) followed by 2-course of additional DNF therapy and 1-year S-1 maintenance

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) histologically proven thoracic esophageal cancer (UICC-TMN, 7th) (2) clinical stage IB-III (nonT4) (UICC-TMN, 7th) (3) no prior chemotherapy and radiotherapy (4) age 20-75 years (5) an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (6) adequate baseline bone marrow function, adequate hepatic function, adequate renal function, adequate respiratory and cardiac function (7) no prior endoscopic or surgical resection for esophageal cancer (8) patients who are deemed to be tolerable for surgery, but refuse surgery as initial treatment modality (9) able to intake orally (10) a life expectancy of at least 3 months (11) written informed consent was obtained from all patients

Exclusion criteria

Exclusion criteria: (1) prior chemotherapy and radiotherapy (2) history of drug hypersensitivity (3) contraindication for docetaxel, nedaplatin , 5-FU, or G-CSF (4) active concomitant malignancy. (5) severe heart disease (6) severe diabetes mellitus, severe hypertension, active infection (7) interstitial pneumonia or pulmonary fibrosis (8) pregnant or lactating females (9) high fever (10) the investigator considers not suitable for the study

Design outcomes

Primary

Measure	Time frame
1-year progression free survival	—

Secondary

Measure	Time frame
Overall survival Safety Radiation related adverse events Salvage therapy related adverse events Response rate Completion rate for S-1 maintenance therapy	—

Countries

Japan

Contacts

Public ContactHiroyuki Ohnuma

Sapporo Medical University School of Medicine Department of Medical Oncology

ohnuma@sapmed.ac.jp011-611-2111

Outcome results

None listed

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