Safety of Pentoxifylline and Vitamin E With Stereotactic Ablative Radiotherapy (SABR) in Non-small Cell Lung Cancers

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Non-small Cell Lung Cancers

Intervention / Treatment
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* Radiation: stereotactic ablative radiotherapy (SABR)
* Drug: Pentoxifylline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: radiotherapy (SABR) plus pentoxifylline<br>standard of care radiotherapy (SABR) plus pentoxifylline and Vitamin E | Radiation: stereotactic ablative radiotherapy (SABR)<br>* standard of care radiation therapy<br>Drug: Pentoxifylline<br>* pentoxifylline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| primary endpoint is to estimate overall treatment-related toxicity |  | 36 months-end of trial | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate progression free survival |  | 12 months | 
| Estimate tumor failure |  | 12 months | 
| estimate overall survival |  | 12 months |