A Feasibility Study of Trimodality Therapy Including Concurrent Chemoradiation Followed by Surgery for Pathologically-proven Clinical Stage IIIA-N2 Non-small Cell Lung Cancer
- Conditions
- on-small Cell Lung Cancer
- Registration Number
- JPRN-UMIN000006389
- Lead Sponsor
- West Japan Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Not provided
1) CT revealed apparent extra-nodal invasion 2) The patient has active previous or concomitant malignancies (synchronous malignancies or metachronous malignancies with the disease-free interval of 5years or less), other than cured carcinoma in situ or intramucosal cancer 3) The patiet has uncontrolld hyoertension 4) The patient has uncontrolled diabetes mellitus 5) The patient has symptomatic congestive heart failure, uncontrolled arrhythmia or ischemic heart disease. 6) The patient has uncontrolled gastrointestinal bleeding or peptic ulcer. 7) The patients has active local or systemic infection, which should be treated 8) Positive serum HBs antigen (by quantitative or qualitative evaluation) 9) The patient has continual diarrhea, defined as watery stool (three times or more in one day) 10) The patients has intestinal paralysis or obstruction 11) The patient has a history of severe drug allergy 12) The patients has peripheral sensory or motor neuropathy of grade 2 or more at the time of registration 13) The patient has a history of allergy against agents containing polyoxyethilene oil containing (eg. Cyclosporine injection agent) or platinum agents 14) The patients has agents against alcoholism (eg. Disulfiram, cyanamide) 15) Chest roentogenogram shows apparent interstitial pneumonia or pulmonary fibrosis 16) The patient has persistent systemic (oral or intravenous) or intra-articular administration of steroids 17) The patient has psychiatric disorders that may comprise the patient's ability to comply with the study 18) The patient is pregnant, may be pregnant, or is lacting. The patient, if is of child-bearing potential, does not practice contraception. 19) The patient has a history of previous radiation therapy, and the radiation field is overlapped with the current radiation therapy field 20) In the view of the investigator, the patient can and will comply with the requirement of the protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete Resection Rate after Surgary following Preoperative Induction Chemo-radiation Therapy
- Secondary Outcome Measures
Name Time Method Disease-free Survival Rate at 2 Years Progression-free Survival Rate at 2 Years Overall Survival Rate at 2 Years Effect of Preoperative Chemoradiation Therapy (Objective Radiological Response Rate,and Pathological Evaluation) Completion Rate of Entire Protocol Treatment Consisting Preoperative Induction Chemoradiotherapy and Surgery followed by Postoperative Adjuvant Chemotherapy Mortality and Morbidity