Radiation Therapy in Treating Patients With Non Small Cell Lung Cancer That Has Been Completely Removed by Surgery
Basic Trial Information
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving radiation therapy after surgery is more effective than no radiation therapy in treating patients with non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to no radiation therapy in treating patients with non-small cell lung cancer that has been completely removed by surgery.
Further Study Information
OUTLINE: This is a multicenter, randomized study.
Patients are stratified according to participating center, prior chemotherapy (neoadjuvant alone vs adjuvant vs none), number of lymph stations involved (0 vs 1 vs ≥ 2), histology (squamous cell vs other), and use of pretreatment positron emission tomography scans (yes vs no). Patients are randomized to 1 of 2 treatment arms.
PROJECTED ACCRUAL: A total of 700 patients will be accrued for this study.
INCLUSION CRITERIA :
1. Histological evidence of non-small cell lung cancer (NSCLC)
2. Complete resection by lobectomy, bilobectomy or pneumonectomy (i.e patients with positive margins) or extra-capsular mediastinal nodal extension breaching the surface of the pathological specimen should not to be included
3. Mediastinal lymph node exploration (lymph node sampling or systematic dissection of lymph nodes at stations 2, 4 and 7 in case of upper/middle right-sided lung cancer; 4, 7, 8 and 9 in case of lower right-sided lung cancer; 5, 6 and 7 in case of upper left -sided lung cancer; 7, 8 and 9 in case of lower left-sided lung cancer is recommended)
4. Pathologically or cytologically documented N2 mediastinal nodal involvement, at the time of surgery if no preoperative chemotherapy or before preoperative chemotherapy, according to the criteria of the joint AJCC and UICC classification, clinical N2 patients without cytological or histological documentation of mediastinal node involvement before preoperative chemotherapy can be included in the study if and only if, they have histologically confirmed N2 disease at the time of surgery
5. Prior chemotherapy is allowed (pre-operative or post-operative adjuvant chemotherapy, or both)
6. Patient aged ≥ 18 years
7. Good Performance status (WHO ≤ 2)
8. Fit enough to receive curative radiotherapy
9. Adequate pulmonary function with post-operative FEV1 after surgery > 1 l or over 35% theoretical value
10. Signed informed consent form
1. Documented metastases, (except for ipsilateral nodule(s) in a different lobe after pneumonectomy or bi-lobectomy)
2. Major pleural or pericardial effusion
3. Synchronous contra-lateral lung cancer
4. Clinical progression during post-operative chemotherapy
5. Previous chest radiotherapy
6. Intention of concomitant chemotherapy during radiotherapy
7. Weight loss in the previous 6 months before surgery ≥ 10 %
8. Evidence of severe or uncontrolled systemic disease as judged by the investigator
9. Recent (< 6 months) severe cardiac disease (arrhythmia, congestive heart failure, infarction, pace-maker) or pulmonary disease
10. Current or past history of neoplasm other than non-small cell lung cancer diagnosed within the last 5 years, except :
11. Pregnancy or breast feeding or inadequate contraceptive measures during treatment
12. Patients who, for family, social, geographic or psychological reasons, cannot be adequately followed up and/or are incapable of undergoing regular controls
13. Patient deprived of freedom or under guardianship
Trial Contact Information
Trial Lead Organizations/Sponsors
Institut Gustave Roussy
Cecile Le Pechoux, MD, Study Chair
Cécile LE PECHOUX, MD
Ph: 0142114757 Ext.+33
Link to the current ClinicalTrials.gov record.
Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.