Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer

Phase 1

Completed

• Conditions: Lung Cancer

• Registration Number: NCT00002577
• Lead Sponsor: Radiation Therapy Oncology Group

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy in treating patients with non-small cell lung cancer that cannot be surgically removed.

Detailed Description

OBJECTIVES: I. Assess the treatment related morbidity associated with escalating doses of 3-dimensional conformal radiotherapy (3D-CRT) in patients with locally advanced, inoperable, non-small cell lung cancer. II. Determine the maximum tolerated dose of 3D-CRT in these patients. III. Evaluate the morbidity associated with high dose 3D-CRT for carcinoma of the lung.

OUTLINE: This is a dose escalation study. Patients are stratified by the percentage of total lung volume (TLV) receiving greater than 20 Gy of radiation (less than 25% vs 25% to less than 37% vs at least 37%). As of 7/1/1999, the third stratum closed to accrual. Patients receive 3-dimensional conformal radiotherapy (3D-CRT) 5 days a week for either 6-7 weeks, 7-8 weeks, or 9-10 weeks (depending on the cohort). Within each TLV stratum, cohorts of 15-36 patients receive escalating doses of 3D-CRT until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which less than 15% of patients experience dose limiting toxicity. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 15-36 patients per cohort will be accrued for this study within 1 year. As of 7/1/1999, the third stratum closed to accrual.

Study Timeline

• Study Start: 1995-07
• Study First Submitted: 1999-11-01
• Primary Completion: 2003-01
• Study First Submitted QC: 2004-02-26
• Study First Posted: 2004-02-27
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-18
• Last Update Posted: 2013-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (242)

University of Alabama at Birmingham Comprehensive Cancer Center; 🇺🇸 Birmingham, Alabama, United States

Huntsville Hospital System; 🇺🇸 Huntsville, Alabama, United States

Comprehensive Cancer Institute of Huntsville; 🇺🇸 Huntsville, Alabama, United States

MBCCOP - Gulf Coast; 🇺🇸 Mobile, Alabama, United States

Alabama Oncology, LLC; 🇺🇸 Montgomery, Alabama, United States

Radiation Oncology Associates of West Alabama; 🇺🇸 Tuscallosa, Alabama, United States

Providence Alaska Medical Center; 🇺🇸 Anchorage, Alaska, United States

Foundation for Cancer Research and Education; 🇺🇸 Phoenix, Arizona, United States

Mount Diablo Medical Center; 🇺🇸 Concord, California, United States

Cancer Center and Beckman Research Institute, City of Hope; 🇺🇸 Duarte, California, United States

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