Phase III Study Comparing Post-Operative Conformal Radiotherapy to No Post-Operative Radiotherapy in Patients With Completely Resected Non-Small Cell Lung Cancer and Mediastinal N2 Involvement [Lung ART]
- Compare the disease-free survival of patients with completely resected non-small cell
lung cancer treated with conformal thoracic radiotherapy vs no radiotherapy.
- Determine the toxicity, in particular cardiac and pulmonary toxicity, of these regimens
in these patients.
- Compare the local control in patients treated with these regimens.
- Determine patterns of recurrence in patients treated with these regimens.
- Determine the overall survival of patients treated with these regimens.
- Assess second cancers in patients treated with these regimens.
- Assess prognostic factors and predictive factors of treatment effect on disease-free
survival and overall survival of patients treated with these regimens.
- Determine the cost per recurrence-free year of life.
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.
- Arm I: Beginning within 4-8 weeks after surgery or 2-6 weeks after chemotherapy,
patients undergo adjuvant thoracic conformal radiotherapy once daily, 5 days per week,
for 6 weeks.
- Arm II: Patients do not undergo adjuvant thoracic radiotherapy. After completion of
study therapy, patients are followed periodically for up to10 years.
PROJECTED ACCRUAL: A total of 700 patients will be accrued for this study.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease-free survival (DFS)
assessed up every 3 and 6 months after randomization, every 6 months for the fist three years and yearly afterward
Cecile Le Pechoux, MD
Gustave Roussy, Cancer Campus, Grand Paris
France: Agence Nationale de Sécurité du Médicament et des produits de santé