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

Description

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

Conditions

Non-small Cell Lung Cancers

Study Overview

Study Details

Study 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

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

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

Condition
Non-small Cell Lung Cancers
Intervention / Treatment

-

Contacts and Locations

Louisville

James Graham Brown Cancer Center, U of Louisville, Louisville, Kentucky, United States, 40202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

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.
  • 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

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Louisville,

Neal E Dunlap, MD, PRINCIPAL_INVESTIGATOR, James Graham Brown Cancer Center-U of Louisville

Study Record Dates

2025-12