NCT00346320

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: NCIC Clinical Trials Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
RADIATION	3-dimensional conformal radiation therapy	3-dimensional conformal radiotherapy, 60 Gy in once daily 4 Gy fractions (Monday to Friday) over 3 weeks

Timeline

• Start date: 2006-08-02
• Primary completion: 2012-02-28
• Completion: 2014-08-20
• First posted: 2006-06-29
• Last updated: 2023-08-04

Locations

19 sites across 1 country: Canada