Phase II study of neoadjuvant DCF followed by adjvant S-1 for pN+ forn locally advanced esophageal cancer.
- Conditions
- Esophageal cancer
- Registration Number
- JPRN-jRCTs031180375
- Lead Sponsor
- Seto Yasuyuki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 110
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Recurrence free survival (RFS)
- Secondary Outcome Measures
Name Time Method Overall survival(OS) , Response rate (RR), R0 resction rate,<br>pN positive rate, Adverse events