JCOG1510: A phase III study of tri-modality combination therapy with induction docetaxel plus cisplatin and 5-fluorouracil (DCF) vs definitive chemoradiotherapy for locally advanced unresectable squamous cell carcinoma of the thoracic esophagus
- Conditions
- locally advanced unresectable squamous cell carcinoma of the thoracic esophagus
- Registration Number
- JPRN-jRCTs031180181
- Lead Sponsor
- DAIKO Hiroyuki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 230
1) Histologically proven squamous cell carcinoma, adenosquamous carcinoma or basaloid cell carcinoma by endoscopic biopsy for the primary esophageal tumor.
2) Primary tumor located in thoracic esophagus (the UICC-TNM 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 bleeding and symptom related to airway constriction which are induced by esophageal hiatus, esophagorespiratory fistula, esophagomediastinal fistula, or artery invasion 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, and patients with both unresectabel supraclavicular lymph nodes and celiac artery lymph nodes metastases.
4) No distant metastases except supraclavicular lymph nodes metastases in accordance with cervical to abdominal contrast enhanced CT.
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
12) Agreement with surgical procedure as protocol treatment if R0 esophagectomy is judged as possible.
13) Written informed consent.
1) Synchronous or metachronous (within 5 years) malignancies.
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 antibody.
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 history of allergy to iodine.
10) Diabetes mellitus uncontrollable with continuous use of insulin or hypoglycemic agents.
11) Severe emphysema or pulmonary fibrosis based on chest CT.
12) Uncontrolled arterial hypertension.
13) History of unstable angina pectoris with new onset or exacerbation within three weeks or myocardial infarction within six months before registration.
14) Uncontrolled valvular disease, dilated cardiomyopathy, and hypertrophic cardiomyopathy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method overall survival
- Secondary Outcome Measures
Name Time Method 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