Effect of Pentoxifylline and Vitamin E in Preventing Radiation-induced Toxicity in the Treatment of Recurrent or New Primary NSCLC Using Stereotactic Ablative Radiotherapy in Patients Previously Treated With Thoracic Radiation
Effect of Pentoxifylline and Vitamin E in Preventing Radiation-induced Toxicity in the Treatment of Recurrent or New Primary NSCLC Using Stereotactic Ablative Radiotherapy in Patients Previously Treated With Thoracic Radiation
The objective of this prospective phase II protocol is to assess the toxicity and efficacy of pentoxifylline and SABR in the re-treatment of recurrent or new lung cancers
3.1 Inclusion Criteria: - Eligibility Criteria
3.1.1 Age >/= 18 years
3.1.2 ECOG performance status 0-1 3.1.3 Histologically proven diagnosis of a prior thoracic malignancy treated with thoracic external beam radiotherapy with or without systemic chemotherapy
3.1.4 Pathologic or clinical diagnosis of a new or loco-regional recurrent lung malignancy. A reasonable attempt should be made to make a pathologic diagnosis of malignancy (ie. bronchoscopy, CT guided lung biopsy)
3.1.5 Imaging as follows:
3.1.6 Pulmonary function test (PFTs), including diffusion capacity within 8 weeks of registration
3.1.7 Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential.
3.1.6 Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control
3.1.7 Patients must provide study specific informed consent prior to study entry.
Exclusion Criteria:
- 3.2 Exclusion Criteria
3.2.1. No previously reported thoracic radiotherapy
3.2.2. FEV1 <20% predicted and/or DLCO <20% predicted
3.2.2. Pregnant women or lactating women
3.2.3 Chemotherapy within 4 weeks of the initiation of SABR
3.2.4 Plans to administer systemic chemotherapy overlapping with radiotherapy