JCOG1109: A randomized controlled phase III comparing CF versus DCF versus CF-RT as neoadjuvant treatment for locally advanced esophageal cancer

JRCT ID: jRCTs031180202

Registered date:07/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: clinical stage IB/II/III thoracic esophageal cancer
• Date of first enrollment: 07/03/2019
• Target sample size: 600
• Study type: Interventional

Intervention(s)

A) Two courses of preopeartive chemotherapy with cisplatin (80 mg/m2/day, day 1) and 5-FU (800 mg/m2/day, day 1-5) repeated every 3 weeks followed by surgery
B) Three courses of preoperative chemotherapy with docetaxel (70 mg/m2/day, day 1), cisplatin (70 mg/m2/day, day1) and 5-FU (750 mg/m2/day, day 1-5) repeated every 3 weeks followed by surgery
C) Two courses of preoperative chemoradiotherapy (41.4Gy/23fr) with cisplatin (75 mg/m2/day, day 1) and 5-FU (1000 mg/m2/day, day 1-4) repeated every 4 weeks followed by surgery

Outcome(s)

• Primary Outcome: Overall Survival
• Secondary Outcome: Progression-free survival, R0 resection rate, response proportion, complete response proportion, adverse events during preoperative therapy, surgical morbidity, late toxicity, serious adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

1) Histologically proven squamous cell carcinoma, adenosquamous carcinoma, or basaloid cell carcinoma by endoscopic biopsy from esophageal primary tumor
2) All lesion located in the thoracic esophagus (the 7th edition of the UICC TNM classification)
3) Clinical stage IB, II, III (excluding T4) based on the 7th edition of the UICC TNM classification
4) Aged 20 to 75 years old
5) ECOG performance status of 0 or 1
6) Measurable lesions not required
7) No prior therapy against esophageal cancer except for the following cases
a) Complete resection by EMR/ESD (diagnosed as pT1a-EP (M1) or pT1a-LPM (M2) tumors)
b) Complete resection by EMR/ESD (diagnosed as pT1a-MM (M3) tumor without lymphovascular invasion)
8) No prior chemotherapy, radiotherapy or hormonal therapy against any cancers except for hormonal therapy for prostate cancer with more than 5 years of disease-free interval
9) Adequate organ functions
10) R0 esophagectomy is judged as possible by open (or laparoscopic) thoracotomy and laparotomy
11) Written informed consent

Exclude criteria

1) Simultaneous or metachronous (within 5 years) double cancers, except for intramucosal tumor curatively resected by local therapy
2) Active infection requiring systemic therapy
3) Positive HBs antigen, HCV antibody or HIV antibody
4) Pregnant or lactating women or women of childbearing potential
5) Psychiatric disease or symptom
6) Patients requiring systemic steroids medication (internal or intravenous use)
7) Requiring continuous administration of flucytosine, phenytoin or warfarin potassium
8) Iodine hypersensitivity
9) Hypersensitivity for docetaxel, cisplatin or polysorbate 80 containing drug
10) Diabetes mellitus with HbA1c of 6.5% (value of Japan Diabetes Society (JDS)), 6.9% (value of National Glycohemoglobin Standardization Program (NGSP))or higher
11) Severe emphysema or pulmonary fibrosis detected by lung function test or CT
12) Poorly controlled hypertension
13) Unstable angina (onset or worse heart attack of angina within 3 weeks), or with a history of myocardial infarction within 6 months.

Related Information

• Primary Sponsor: Kato Ken
• Source(s) of Monetary Support: National Cancer Center Japan,Ministry of Health, Labour and Welfare,Japan Agency for Medical Research and Development
• Secondary ID(s): UMIN000009482