Clareo Health | 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
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
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Keep this study
Lead
Cancer Trials Ireland
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.
Age
0–120
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
