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

Launched by UNIVERSITY OF LOUISVILLE · Jun 4, 2013

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a combination treatment using pentoxifylline and a type of radiation therapy called Stereotactic Ablative Radiotherapy (SABR) for patients with non-small cell lung cancer that has come back or is newly diagnosed. The goal is to see how well this treatment works and if it causes any side effects. The trial is currently looking for participants who are at least 18 years old and have had a previous lung cancer treatment, specifically those who have a new or recurring lung cancer within the area that was previously treated.

To be eligible for this trial, participants must have a clear diagnosis of lung cancer and meet certain health criteria, including being able to perform daily activities with minimal assistance. They will need to undergo some tests before joining, such as imaging scans and lung function tests, to ensure their safety during the study. Participants will receive detailed information about the trial and will need to provide consent before joining. Overall, this trial aims to explore a new treatment option for lung cancer patients, with a focus on improving their health outcomes.

Gender

ALL

Eligibility criteria

• • 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