NCT00955175

Hypofractionated 3-Dimensional Radiation Therapy in Treating Patients With Newly Diagnosed Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer. ICORG 99-09

Radiation Dose Escalation For Non-Small Cell Lung Cancer Using Hypofractionated 3-Dimensional Conformal Radiation Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Cancer Trials Ireland · Network
• Sex: All
• Age: 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor over a shorter period of time may kill more tumor cells and cause less damage to normal tissue. PURPOSE: This phase II trial is studying the side effects of hypofractionated 3-dimensional radiation therapy and to see how well it works in treating patients with newly diagnosed stage I, stage II, or stage III non-small cell lung cancer.

Detailed description

OBJECTIVES: Primary * To evaluate the acute and long-term radio-induced toxicity (any organ) of hypofractionated 3-dimensional conformal radiotherapy in patients with newly diagnosed stage I-III non-small cell lung cancer. Secondary * To assess the radiological tumor response rate at 3 months after completion of radiotherapy. * To assess the actuarial freedom from thoracic progression rate. OUTLINE: Patients are stratified according to combined lung volume at 25 Gy (≤ 30% vs \> 30%). Patients are assigned to 1 of 3 treatment groups. * Group 1: Patients undergo hypofractionated 3-dimensional conformal radiotherapy 5 days a week for 24 fractions (total of 72 Gy). * Group 2: Patients undergo hypofractionated 3-dimensional conformal radiotherapy 5 days a week for 22 fractions (total of 66 Gy). * Group 3: Patients undergo hypofractionated 3-dimensional conformal radiotherapy 5 days a week for 20 fractions (total of 60 Gy). After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months thereafter.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
RADIATION	hypofractionated radiation therapy	Given 5 days a week for 20, 22, or 24 fractions

Timeline

• Start date: 2000-11-01
• Primary completion: 2009-06-01
• First posted: 2009-08-07
• Last updated: 2016-02-17

Locations

1 site across 1 country: Ireland