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
This trial is active, not recruiting.
|Treatment||hypofractionated radiation therapy|
|Sponsor||ICORG- All Ireland Cooperative Oncology Research Group|
|Start date||November 2000|
|End date||June 2009|
|Trial size||60 participants|
|Trial identifier||NCT00955175, 99-09 ICORG, EU-20922, ICORG-99-09|
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.
|Intervention model||parallel assignment|
Acute radio-induced toxicity as assessed by the RTOG/EORTC acute toxicity grading system weekly during radiotherapy
time frame: 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
time frame: every 3 months for 2 years and then every 6 months thereafter
Tumor response rate (according to WHO response criteria) as assessed by CT scan at 3 months after completion of radiotherapy
time frame: at 3 months after completion of radiotherapy
Actuarial freedom from thoracic progression rate
time frame: ongoing
Male or female participants up to 120 years old.
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
|Official title||Radiation Dose Escalation For Non-Small Cell Lung Cancer Using Hypofractionated 3-Dimensional Conformal Radiation Therapy|
|Principal investigator||Pierre Thirion, MD|
|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.|
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