UnknownPhase 2NCT01871454

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

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

Checked against the public recordLast updated Feb 7, 2024 · Source: ClinicalTrials.gov

StatusUnknown
PhasePhase 2
U.S. locations1
SponsorUniversity of Louisville
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
University of Louisville
Interventions being studied
Radiation: stereotactic ablative radiotherapy (SABR); Drug: Pentoxifylline
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • James Graham Brown Cancer Center, U of LouisvilleLouisville, Kentucky

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 7, 2024. Always confirm current availability with the study team.

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