Safety of Pentoxifylline and Vitamin E With Stereotactic Ablative Radiotherapy (SABR) in Non-small Cell Lung Cancers
Non-small Cell Lung Cancers
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancers
Eligibility Criteria
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)
- Loco-regional is defined as recurrence within the region of the primary tumor or adjacent draining lymph node regions.
- The new lesion or loco-regional recurrence must be within or adjacent to the previously irradiated treatment volume.
3.1.5 Imaging as follows:
- CT scan of the chest with IV contrast within 8 weeks of registration
- Whole body PET scan within 8 weeks of registration
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
Sites / Locations
- James Graham Brown Cancer Center, U of LouisvilleRecruiting
Arms of the Study
Arm 1
Experimental
radiotherapy (SABR) plus pentoxifylline
standard of care radiotherapy (SABR) plus pentoxifylline and Vitamin E