Phase I trial of definitive chemoradiotherapy with paclitaxel, cisplatin, and 5-FU (PCF-RT) for esophageal cancer
Phase 1
- Conditions
- esophageal cancer
- Registration Number
- JPRN-UMIN000014927
- Lead Sponsor
- Aichi Cancer Center Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
Not provided
Exclusion Criteria
1) Histologically proven squamous cell carcinoma or adenocarcinoma or adenosquamous cell carcinoma or basal cell carcinoma of the esophagus 2) Primary lesion are located within the thoracic esophagus (Te) 3) Clinical stage I or II or III or IV (with supraclavicular LN) 4) Total radiation dose is 50.4Gy 5) Aged 20 to 75 years old 6) ECOG PS of 0 or1 7) no need for measurable lesion 8) no previous treatment of esophageal cancer except EMR or ESD 9) no previous chemotherapy or radiotherapy against any other malignancies 10) adequate organ functions 11) refused esophagectomy 12) written informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of dose limiting toxicity
- Secondary Outcome Measures
Name Time Method Adverse events, overall survival, progression free survival, response rate, complete response rate