Neoadjuvant DOS treatment for advanced esophageal cancer

JRCT ID: jRCTs041210023

Registered date:21/05/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Esophageal cancer
• Date of first enrollment: 19/08/2021
• Target sample size: 45
• Study type: Interventional
• Intervention(s): Neoadjuvant docetaxel, oxaliplatin plus S-1 treatment and surgery

Outcome(s)

• Primary Outcome: Pathological response rate
• Secondary Outcome: Overall survival time, disease-free survival time, R0 resection rate, response rate (RECIST v1.0), treatment completion rate, complication rate

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 79age old
• Gender: Both

Include criteria

1) Clinical stage II/III/IVa thoracic esophageal cancer
2) Histologically confirmed squamous cell carcinoma, adenosquamous cell carcinoma or basaloid-squamous cell carcinoma
3) Clinical T1-3
4) Ages between 20 years and 79 years
5) Performance status (PS) 0-1
6) Adequate function of vital organs, including bone marrow, liver, and kidney
7) Written informed consent

Exclude criteria

1) History (within 3 years) of malignancies
2) Active infectious disease
3) Psychiatric disease
4) Continuous systemic steroid therapy
5) Allergy of docetaxel, oxaliplatin or S-1
6) Persistent intestinal bleeding
7) Ineligible for the study at the physician's assessment

Related Information

• Primary Sponsor: Kanda Mitsuro
• Source(s) of Monetary Support: Nagoya University Hospital Funding for Clinical Development