RTOG 0214: A Phase III Comparison of Prophylactic Cranial Irradiation Versus Observation in Patients with Locally Advanced Non-Small Cell Lung Cancer
| Purpose of trial: |
Purpose of this study is to compare the effects of brain irradiation results in patients living longer and also evaluate whether there is a lower risk of tumor in the brain with the use of radiation. In addition the study will evaluate the effects of brain irradiation on the thinking skills and quality of life of those patients who received it |
| Protocol Summary: |
Patients will be randomized to either Group 1 or Group 2. Group 1 will receive brain irradiation for 3 weeks. Group 2 will not receive irradiation. Both groups will be followed for 10 years. Per protocol there will be periodical physical exams and testing required while in the study |
| Sponsoring Department: | Surgery - Division of Cardiothoracic Surgery |
| Sponsoring Company: | Radiation Therapy Oncology Group of the American College of Radiology |
| Investigator: | Stephen R. Hazelrigg, MD |
| Number of other sites in trial: | SIU School of Medicine; Memorial Medical Center, St. John's Hospital |
| Basic Eligibility Criteria: | Newly diagnosed Stage IIIA or Stage IIIB Non-small Cell Lung Cancer having completed definitive locoregional therapy (with surgery and/or radiation therapy, with or without chemotherapy) with complete response, partial response or stable disease after therapy. MRI or CT of the head showing no suspicion for CNS metastases within 6 weeks of study entry. No evidence of extracranial distant metastatic disease. No prior cranial irradiation. Patients will be restaged and enrolled within 16 weeks of completing therapy; acute/subacute greater than or equal to 3 toxicities from previous therapy must be resolved to less than or equal to grade 2 at the time of study entry. Signed informed consent. |
| Age: | 18 years of age or older |
| Contact Person: | Contact Person: Theresa Boley, RN, MSN, APN/FNP Contact Phone: 217-545-5000 Contact Email: tboley@siumed.edu |