Phase II study of neoadjuvant DCF therapy followed by adjvant S-1 monotherapy for pathological lymph node metastacis cases for locally advanced esophageal cancer.

Phase II study of neoadjuvant DCF therapy followed by adjvant S-1 monotherapy for pathological lymph node metastacis cases for locally advanced esophageal cancer. - Phase II study of neoadjuvant DCF followed by adjvant S-1 for pN+ forn locally advanced esophageal cancer.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000027589

Enrollment

Registered

2017-07-01

Start date

2017-07-01

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

neoadjuvant DCF therapy followed by adjvant S-1 monotherapy for pathological lymph node metastacis cases for locally advanced esophageal cancer

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Histologically confirmed esophageal squamous cell carcinoma, adenosquamous carcinoma, or basal cell carcinoma 2.Clinical stage II or III (excluding T4) according to the 7th UICC-TNM classification 3.Age over 20 years old. 4.Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. 5.With or without evaluable lesions according to RECIST ver 1.1. 6.No prior treatment for esophageal cancer, except for (i)-(ii): (i)The depths of invasion are diagnosed as tumor invades lamina propria mucosa(pT1a-LPM) after a curative endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) for esophageal cancer. (ii)The depths of invasion are diagnosed as tumor invades muscularis mucosa(pT1a-MM) and vascular invasion negative after a previous curative EMR or ESD for esophageal cancer. 7.No prior treatment of chemotherapy, radiotherapy or endocrine therapy against any other malignant tumors, except for hormone therapy for prostate cancer, which has improved before 5 years. 8.Adequate organ functions 9.R0 esophagectomy is expected 10.Written informed consent

Exclusion criteria

Exclusion criteria: 1.Synchronous or metachronous (within 5 years) double cancers, except for intoramucosal tumor curatively resected by local therapy 2.With active systemic infection disease 3.With active hepatitis B or C 4.With HIV infection 5.With a history of interstitial pneumonia, pulmonary fibrosis or irradiation pneumonitis 6.Severe psychological illness. 7.With continuous systemic steroid or immune-suppressive drug therapy. 8.Poorly controlled diabetes mellitus or thyroid diseases. 9.Unstable angina within 3 weeks or with a history of acute myocardial infarction within 3months 10.With a history of hypersensitivity to docetaxel, cisplatin or polysorbate 80-containing formulations 11.Pregnant and/or nursing women or men who wish to have children in future 12.Judged to be unfit to participate in this study by investigator

Design outcomes

Primary

Measure	Time frame
Recurrence free survival(RFS)	—

Secondary

Measure	Time frame
Overall survival(OS) Response rate(RR) R0 resction rate pN positive rate Adverse events	—

Countries

Japan

Contacts

Public ContactYasuyoshi Sato

The University of Tokyo Department of Gastrointestinal Surgery

yasuyoshi_s@hotmail.com03-3815-5411

Outcome results

None listed

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