Lung Cancer Clinical Trial
Official title:
Radiation Dose Escalation For Non-Small Cell Lung Cancer Using Hypofractionated 3-Dimensional Conformal Radiation Therapy
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.
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.
;
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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