Status:
RECRUITING
Safety of Pentoxifylline and Vitamin E With Stereotactic Ablative Radiotherapy (SABR) in Non-small Cell Lung Cancers
Lead Sponsor:
University of Louisville
Collaborating Sponsors:
James Graham Brown Cancer Center
Conditions:
Non-small Cell Lung Cancers
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 Criteria
Inclusion
- 1 - Eligibility Criteria
- 1.1 Age \>/= 18 years
- 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
- 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.
- 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
- 1.6 Pulmonary function test (PFTs), including diffusion capacity within 8 weeks of registration
- 1.7 Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential.
- 1.6 Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control
- 1.7 Patients must provide study specific informed consent prior to study entry.
Exclusion
- \- 3.2 Exclusion Criteria
- 2.1. No previously reported thoracic radiotherapy
- 2.2. FEV1 \<20% predicted and/or DLCO \<20% predicted
- 2.2. Pregnant women or lactating women
- 2.3 Chemotherapy within 4 weeks of the initiation of SABR
- 2.4 Plans to administer systemic chemotherapy overlapping with radiotherapy
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT01871454
Start Date
October 1 2013
End Date
December 1 2025
Last Update
February 7 2024
Active Locations (1)
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1
James Graham Brown Cancer Center, U of Louisville
Louisville, Kentucky, United States, 40202