RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2013-10

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT01871454

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Principal Investigator

Neal E Dunlap, MD

PRINCIPAL_INVESTIGATOR

James Graham Brown Cancer Center-U of Louisville

Study Locations (Sites)

James Graham Brown Cancer Center, U of Louisville

Louisville, Kentucky, 40202

United States

Collaborators and Investigators

Sponsor: University of Louisville

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2013-10

Study Completion Date2025-12

Study Record Updates

Study Start Date2013-10

Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

Non-small Cell Lung Cancers