Lung Cancer
Conditions
Keywords
stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer
Brief 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.
Interventions
RADIATIONhypofractionated radiation therapy
Given 5 days a week for 20, 22, or 24 fractions
Sponsors
Cancer Trials Ireland
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed newly diagnosed non-small cell lung cancer meeting 1 of the following stage criteria: * Stage I or II disease * Medically inoperable or patient refused surgery * Stage IIIA or IIIB disease (no pleural effusions) * Radiation dose parameters must satisfy the required study dose-volume constraints PATIENT CHARACTERISTICS: * Karnofsky performance status 70-100% * Weight loss ≤ 10% within 3 months before diagnosis * No other malignancy within the past 5 years, except nonmelanoma skin cancer * No clinically significant cardiovascular disease (e.g., hypertension \[blood pressure \> 150/100 mm Hg\], myocardial infarction or stroke within the past 6 months, or unstable angina) PRIOR CONCURRENT THERAPY: * No concurrent chemotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute radio-induced toxicity as assessed by the RTOG/EORTC acute toxicity grading system weekly during radiotherapy | weekly during radiotherapy |
| Long-term radio-induced toxicity as assessed by the long-term RTOG/EORTC and SWOG (lung) grading system every 3 months for 2 years and then every 6 months thereafter | every 3 months for 2 years and then every 6 months thereafter |
Secondary
| Measure | Time frame |
|---|---|
| Tumor response rate (according to WHO response criteria) as assessed by CT scan at 3 months after completion of radiotherapy | at 3 months after completion of radiotherapy |
| Actuarial freedom from thoracic progression rate | ongoing |
Countries
Ireland
Outcome results
None listed