Radiation Therapy in Treating Patients With Non Small Cell Lung Cancer That Has Been Completely R… (NCT00410683) | Clinical Trial Compass
UnknownPhase 3
Radiation Therapy in Treating Patients With Non Small Cell Lung Cancer That Has Been Completely Removed by Surgery
France500 participantsStarted 2007-02
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Histological evidence of non-small cell lung cancer (NSCLC)
✓. 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
✓. 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)
✓. 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
✓. Prior chemotherapy is allowed (pre-operative or post-operative adjuvant chemotherapy, or both)
✓. Patient aged ≥ 18 years
✓. Good Performance status (WHO ≤ 2)
What they're measuring
1
Disease-free survival (DFS)
Timeframe: assessed up every 3 and 6 months after randomization, every 6 months for the fist three years and yearly afterward