A feasibility study of neoadjuvant docetaxel+cisplatin+fluorouracil (DCF) with pegfilgrastim on day3 for patients with esophageal cancer

JRCT ID: jRCTs041190129

Registered date:16/03/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Esophageal cancer
• Date of first enrollment: 16/03/2020
• Target sample size: 35
• Study type: Interventional

Intervention(s)

Docetaxel 70mg/m2 day1
Cisplatin 70mg/m2 day1
Fluorouracil 750mg/m2/day days1-5
Pegfilgrastim 3.6mg day3
3 courses every 3 weeks

Outcome(s)

• Primary Outcome: Rate of febrile neutropenia
• Secondary Outcome: Rate of Grade 3 or higher neutropenia, curative resection rate, response rate of preoperative treatment, histopathological response rate, histopathological complete response rate, rate of adverse events during preoperative therapy, rate of incidence of perioperative complications, late complication rate, serious adverse event rate, 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