locally advanced unresectable squamous cell carcinoma of the thoracic esophagus
Conditions
Interventions
A: two courses of chemotherapy with cisplatin (70 mg/m2, 2-h intravenous infusion on day 1) and 5-FU (700 mg/m2, 24-h continuous intravenous infusion on days 1-4) repeated every 4 weeks in combination
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven squamous cell carcinoma, adenosquamous carcinoma or basaloid cell carcinoma. Biopsy of accessory lesions is not mandatory. 2) Primary tumor located in thoracic esophagus (the UICC 7th edition). Tumor invading cervical or abdominal esophagus with indication of definitive radiation therapy and accessory lesions with indication of EMR are eligible. 3) Unresectable esophageal cancer based on cervical to abdominal contrast enhanced CT to fulfill either following A) or B), and patients with both unresectable supraclavicular lymph nodes and celiac artery lymph nodes metastases are ineligible. A) cT4b or cT3 that may invade adjacent organs in accordance with UICC-TNM 7th edition and Japanese Classification of Esophageal Cancer 11th edition. B) Other adjacent organs except esophagus are or may be invaded by regional lymph nodes or supraclavicular lymph nodes metastases. 4) No distant metastases except supraclavicular lymph nodes metastases in accordance with cervical to abdominal contrast enhanced CT. Pelvic CT is not mandatory. 5) Diagnosed by radio oncologists before register as a candidate of definitive radiotherapy in 60 Gy within the dose constraints of other organs. CT for treatment planning before register is not mandatory. 6) Aged 20 to 75 years old. 7) ECOG Performance status 0 or 1. 8) Measurable lesions not required. 9) No prior treatment for esophageal cancer except endoscopic resection. 10) No prior chemotherapy and radiotherapy for any cancer. 11) Sufficient organ functions; fulfilling all of the following conditions within 14 days; i. Neutrophil >= 2,000/mm3 ii. Platelet >= 100,000/mm3 iii. Hb >= 9.0 g/dL iv. T.Bil <= 1.5 mg/dL v. AST <= 100 IU/L vi. ALT <= 100 IU/L vii. CCr >= 60mL/min (Cockcroft-Gault) viii. SpO2 (room air) >=95% 12) Agreement with surgical procedure as protocol tratment if R0 esophagectomy is judged as possible. 13) Written informed consent.
Exclusion criteria
Exclusion criteria: 1) Synchronous or metachronous (within 5 years) malignancy except cancer with 5-year relative survival rate of 95% or more such as carcinoma in situ, intramucosal tumor, or early stage cancers. 2) Prior surgery for head and neck superficial carcinoma within 5 years. 3) Diagnosed with active infectious disease requiring systemic treatment by imaging or bacteriological inspections, and body temperature >= 38 degrees Celsius. 4) Positive for HBs antigen or HIV antigen. 5) Pregnancy, possible pregnancy, within 28 days after delivery or breast-feeding. Male subjects who want pregnancy of their partner. 6) Psychological disorder difficult to participate in this clinical study. 7) Receiving continuous systemic corticosteroid or immunosuppressant treatment. 8) Under treatment by flucytosine, phenytoin, or warfarin potassium . 9) Previous histry of allergy to iodine. 10) Diabetes mellitus uncontrollable with continuous use of insuline or hypoglycemic agents. 11) Severe emphysema or pulmonary fibrosis based on chest CT. 12) Uncontrolled arterial hypertension. 13) History of unstable angina pectoris within three weeks or myocardial infarction within six months before registration. 14) Uncontrolled valvular disease, dilated cardiomyopathy, and hypertrophic cardiomyopathy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival, complete response proportion of chemoradiotherapy, response proportion of DCF (in case of Arm B), adverse events of DCF and chemoradiotherapy, late onset adverse events, perioperative complications (both Arm A and Arm B) | — |
Countries
Japan
Contacts
Public ContactHiroki Hara
JCOG1510 Coordinating Office Saitama Cancer Center Department of Gastroenterology
Outcome results
None listed