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

Phase 2

Recruiting

• Conditions: Non-small Cell Lung Cancers
• Interventions: Radiation: stereotactic ablative radiotherapy (SABR); Drug: Pentoxifylline

• Registration Number: NCT01871454
• Lead Sponsor: University of Louisville

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-04
• Study First Submitted QC: 2013-06-04
• Study First Posted: 2013-06-06
• Study Start: 2013-10
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-07
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 59

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
radiotherapy (SABR) plus pentoxifylline	stereotactic ablative radiotherapy (SABR)	standard of care radiotherapy (SABR) plus pentoxifylline and Vitamin E
radiotherapy (SABR) plus pentoxifylline	Pentoxifylline	standard of care radiotherapy (SABR) plus pentoxifylline and Vitamin E

Primary Outcome Measures

Name	Time	Method
primary endpoint is to estimate overall treatment-related toxicity	36 months-end of trial

Secondary Outcome Measures

Name	Time	Method
Estimate progression free survival	12 months
Estimate tumor failure	12 months
estimate overall survival	12 months

Trial Locations

Locations (1)

James Graham Brown Cancer Center, U of Louisville; 🇺🇸 Louisville, Kentucky, United States