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

  • STATUS
    Recruiting
  • End date
    Dec 30, 2025
  • participants needed
    59
  • sponsor
    University of Louisville
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Updated on 30 June 2021
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Summary

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

Details
Condition Non-small Cell Lung Cancers
Treatment Pentoxifylline, stereotactic ablative radiotherapy (SABR)
Clinical Study IdentifierNCT01871454
SponsorUniversity of Louisville
Last Modified on30 June 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Eligibility Criteria
1.1 Age >/= 18 years
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
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
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
1.6 Pulmonary function test (PFTs), including diffusion capacity within 8
weeks of registration
1.7 Negative serum pregnancy test within 2 weeks prior to registration for
women of childbearing potential
1.6 Women of childbearing potential and male participants who are sexually
active must agree to use a medically effective means of birth control
1.7 Patients must provide study specific informed consent prior to study
entry

Exclusion Criteria

2 Exclusion Criteria
2.1. No previously reported thoracic radiotherapy
2.2. FEV1 <20% predicted and/or DLCO <20% predicted
2.2. Pregnant women or lactating women
2.3 Chemotherapy within 4 weeks of the initiation of SABR
2.4 Plans to administer systemic chemotherapy overlapping with radiotherapy
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