Phase II study of neoadjuvant chemoradiation therapy with cisplatin plus fluorouracil for esophageal cancer

JRCT ID: jRCT1041180004

Registered date:11/09/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Esophageal cancer
• Date of first enrollment: 10/09/2018
• Target sample size: 21
• Study type: Interventional

Intervention(s)

Chemoradiation
Cisplatin 75 mg / m2 day 1
Fluorouracil 1000 mg / m2 / day days 1 - 4 (96 hours), 2 courses every 4 weeks
Radiotherapy 1.8 Gy / fr x 23 fr Total 41.4 Gy

Outcome(s)

• Primary Outcome: Response rate
• Secondary Outcome: Rate of adveser events, response rate, rate of complete resection, histopathological response rate, histopathological complete response rate, rate of perioperative complication, rate of late complication, rate of severe adverse events, progression-free survival, and overall survival

Key inclusion & exclusion criteria

• Age minimum: 20age old
• Age maximum: 75age old
• Gender: Both

Include criteria

1.ECOG PS 0-1
2.Endoscopic biopsy of esophageal primary lesion histologically diagnosed as squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma or basal cell carcinoma.
3. Any of the following based on TNM classification (UICC-TNM 7 th edition)
1) cStage IB
2) cStage II
3) cStage III Infiltration into the trachea at the cervical /cervical chest boundary (T4) is eligible. Excluding other T4. So-called borderline-resectable T4 disease, not clearly diagnosed as T4, is eligible.
4) cStage IV with supraclavicular lymph node metastasis and without other distant metastasis.
4. Adequate organ function.

Exclude criteria

1) Clear T4 other than invasion of cervical / cervical gastrointestinal tract esophageal cancer
2) Distant metastasis to other than supraclavicular lymph nodes.
3) Esophagogastric junction lesion of which main lesion is located in the stomach rather than the esophagus.
4) Judged not to be eligible by the researchers

Related Information

• Primary Sponsor: Maeda Osamu