Spots Global Cancer Trial Database for Radiation in Stage I or Stage II Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Radiation in Stage I or Stage II Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery

Official Title: A Phase II Study of Accelerated Hypofractionated 3-Dimensional Conformal Radiotherapy (3DCRT) For Inoperable Stage I/II Non-Small Cell Lung Cancer (NSCLC)

Study ID: NCT00346320

Conditions

Lung Cancer

Interventions

3-dimensional conformal radiation therapy

Study Description

Brief Summary: RATIONALE: 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. PURPOSE: This phase II trial is studying how well radiation therapy works in treating patients with stage I or stage II non-small cell lung cancer that cannot be removed by surgery.

Detailed Description: OBJECTIVES: Primary * Determine the local tumor control rate at 2 years after accelerated hypofractionated 3-dimensional, conformal radiotherapy in patients with inoperable T1-3 N0 M0 non-small cell lung cancer. Secondary * Determine the toxicities of this regimen in these patients. * Determine the rates of regional and distant disease recurrence in these patients. * Determine the progression-free and overall survival of patients treated with this regimen. * Determine the changes in pulmonary function after treatment in these patients. * Assess the quality of life of patients after treatment. OUTLINE: This is a multicenter, prospective study. Patients undergo accelerated hypofractionated conformal radiotherapy 5 days a week for up to 3 weeks (15 doses) in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at week 3 of radiotherapy, at 1 month after completion of radiotherapy, and then every 4 months for 1 year. After completion of study treatment, patients are followed periodically for 5 years. PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.