DCF-RT for T4b EC

JRCT ID: jRCTs051190058

Registered date:08/10/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Esophageal cancer
• Date of first enrollment: 01/09/2019
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Chemoradiotherapy with docetaxel, cisplatin, and 5-fluorouracil (DCF-R)

Outcome(s)

• Primary Outcome: Adverse effect
• Secondary Outcome: Treatment completion rate, complete response rate, treatment response rate, overall survival, salvage surgery rate

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Miyata Hiroshi