JPRN-jRCTs051190058
Recruiting
Phase 2
Chemoradiotherapy with docetaxel, cisplatin, and 5-fluorouracil (DCF-R) in esophageal cancer invading aorta or trachea : A phase 2 trail
Miyata Hiroshi0 sites20 target enrollmentOctober 8, 2019
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Esophageal cancer
- Sponsor
- Miyata Hiroshi
- Enrollment
- 20
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1 The first occurrence of thoracic esophageal cancer for which diagnosis of squamous cell carcinoma (including adenosquamous cell carcinoma and basal cell carcinoma) was obtained by histology
- •Example (including cases that partially affect the cervical esophagus or abdominal esophagus)
- •2 Thoracic esophagus cancer (cT4 esophagus cancer) with clinical involvement of the aorta or trachea without curative organ metastasis.
- •Abdominal lymph node (No. 1, 2, 3, 7, 9\) metastasis\-positive cases are eligible.
- •3 over 20 years old and under 80 years old
- •4 PS (ECOG) 0\-1
- •5 There is no prior treatment for esophageal cancer. However, endoscopic resection (pT1a, ly0, v0\) obtained with curative resection is acceptable.
- •6 No history of radiation exposure to neck and chest
- •7 Main organ function is maintained
- •8 Patients who have obtained consent from the patient
Exclusion Criteria
- •1 Chemoradiotherapy is difficult to perform due to abnormalities in major organs (brain, heart, lung, liver, kidney)
- •2 active double cancer
- •(However, cases that can be cured by treatment are eligible)
- •3 Perforation or penetration case by primary lesions or lymph nodes
- •4 Cases with a history of serious drug hypersensitivity
- •5 pregnant women, lactating women and women with the possibility and intention of pregnancy
- •6 Cases with severe pulmonary emphysema or pulmonary fibrosis or interstitial pneumonia recognized by lung function test, CT
- •7 HBs antigen positive cases
- •8 Cases deemed inappropriate by the investigator
Outcomes
Primary Outcomes
Not specified
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