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

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

Recruiting
18 years and older
All
Phase 2

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Overview

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

Eligibility

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

Study details
    Non-small Cell Lung Cancers

NCT01871454

University of Louisville

16 February 2024

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