Stage III non-small cell lung cancer
Conditions
Interventions
Concurrent chemotherapy(carboplatin [CBDCA] -AUC 2mg/ml min day 1, paclitaxel [PTX] -40mg/m^2 day 1)is weekly given for 4 cycles. Twice daily radiotherapy (1.5Gy/fr, total dose
66Gy) using 3D-CRT starts on day 1, followed by 2 cycles of consolidation chemotherapy ( CBDCA-AUC 5mg/ml min day 1 plus PTX-200mg/m^2 day 1).
Sponsors
West Japan Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Histologically or cytologically confirmed NSCLC. (2) Expected more than 90 days survival. (3) Stage IIIA, IIIB based on General Rule for Clinical and Pathological Record of Lung Cancer (The 7th Edition) without the treatment history of chemotherapy, radiotherapy and surgery (except explorative thoracotomy). (4)Unexpected complete tumor resection. (5)Expected completion of planed radiotherapy judged by a radiation oncologist, based on 3-dimentional radiotherapy planning V20 of the lung <=35% PRV of the spinal cord Dmax <=52Gy Dmax of the esophagus <=68Gy V50 of the esophagus<=50% (6) ECOG performance status 0-1 (7) Patients are >=20 years and < 75 years of age at the time of signature of the informed consent. (8) 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 Platelet>=100,000/mm3 Hemoglobin>=9.5g/dl AST,ALT<=100IU/L Total bilirubin<=1.5 mg/dL Creatinin<=1.5mg/dL PaO2 (room air) >=70Torr (9) Written informed consent
Exclusion criteria
Exclusion criteria: (1)Chest CT shows active interstitial pneumonia or pulmonary fibrosis or severe pulmonary emphysema. (2)The patient has SVC syndrome. (3)The patient has one or more nodal metastases as listed below; supraclavicular node, anterior scalene node, contralateral hilar node. These nodes are assumed as positive if they are FDG/PET positive and have more than 5mm diameter. Malignant pleural effusion, malignant pericardial effusion and malignant lymphangitis are also ineligible. (4)The patient has a history of previous thoracic radiotherapy. (5)The patient has active previous or concomitant malignancies. (6)The patient has uncontrolled diabetes mellitus. (7) The patients has active local or systemic infection, which should be treated. (8)The patient has a severe complication (ex.gastrointestinal bleeding, heart disease, glaucoma, HIV infection). (9) The patient has a history of allergy against agents containing polyoxyethilene oil or severe drug allergy. (10) The patient has psychiatric disorders that may comprise the patient s ability to comply with the study. (11) Positive serum HBs antigen or HCV antibody. (12) The patient is pregnant, may be pregnant, or is lacting. The patient, if is of child-bearing potential, does not practice contraception. (13) In the view of the investigator, the patient can and will comply with the requirement of the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Three-year survival ratio | — |
Secondary
| Measure | Time frame |
|---|---|
| Annual year survival ratio, Median survival time, Local control rate, The ratio of the patients who completed the course, Adverse events | — |
Countries
Japan
Contacts
Public ContactShinichiro Nakamura
West Japan Oncology Group datacenter
Outcome results
None listed