Non-small Cell Lung Cancer
Conditions
Interventions
Induction chemo-radiotherapy (weekly carboplatin [CBDCA] plus paclitaxel [PTX] with concurrent radiation [50Gy]) followed by surgery and postoperative consolidation chemotherapy (2 cycles of bolus CBD
Sponsors
West Japan Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologicall or cytologically confirmed non-small cell lung cancer 2) Radiologicall suspected and pathologicall confirmed mediastinal nodal metastasis (N2) Radiological suspicion of N2 isdefined as follows: * Enlarged mediastinal node (1cm or more in the short-axis diameter) on CT, or * Diagnosis of mediastinal nodal metastasis by a radiologist on FDG-PET scan 3) Expected complete tumor resection achieved with (bi-)lobectomy (or pneumonectomy) plus nodal dissection Ineligible, if a mediastinal involved node showed extra-nodal invasion 4) V20 equal or less than 35% and Expected completion of planned radiation therapy judged by a radiation oncologist, based on 3-dimensional radiation therapy planning 5) No prior therapy for the current lung cancer 6) Patients is >=20 years and <75 years of age at the time of signature of the informed consent 7) ECOG performance status of 0 or 1 8) Expected residual forced expiratory volume in 1 second (FEV1.0) after surgery >=40% of estimated normal (FEV1.0), which was calculated based on each patient's height and weight 9) Adequate major organ function (including bone-marrow, heart, liver, renal function) as assessed by standard laboratory criteria as follows: White blood cell >=4,000/mm3 Neutrophil >=2,000/mm3 Hemoglobin >=10.0g/dl Platelet >=100,000/mm3 Serum albumin >=3.0g/dl Total bilirubin <=1.5 mg/dL AST, ALT <=100IU/L Creatinin <=1.2mg/dL Creatinin clearance >=60mL/min (calculated by the Cockcroft-Gault method, or measured by the 24-hour clearance method) Arterial oxgen pressure measured by room air respiration (PaO2) >=70mmHg (not substitute for percutaneous oxygen [SpO2]) 10) Written informed consent from the patient after adequate explanation of the study prior to the registration
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Resection Rate after Surgary following Preoperative Induction Chemo-radiation Therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactShinichiro Nakamura
West Japan Oncology Group datacenter
Outcome results
None listed