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

NCT ID: NCT01871454

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2025-12-31

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

Conditions

Non-small Cell Lung Cancers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

radiotherapy (SABR) plus pentoxifylline

standard of care radiotherapy (SABR) plus pentoxifylline and Vitamin E

Group Type: EXPERIMENTAL

stereotactic ablative radiotherapy (SABR)

Intervention Type: RADIATION

standard of care radiation therapy

Pentoxifylline

Intervention Type: DRUG

pentoxifylline

Interventions

stereotactic ablative radiotherapy (SABR)

standard of care radiation therapy

Intervention Type: RADIATION

Pentoxifylline

pentoxifylline

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

3.2.1. 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

James Graham Brown Cancer Center

OTHER

Sponsor Role: collaborator

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Neal Edward Dunlap

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Neal E Dunlap, MD

Role: PRINCIPAL_INVESTIGATOR

James Graham Brown Cancer Center-U of Louisville

Locations

James Graham Brown Cancer Center, U of Louisville

Louisville, Kentucky, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Teresa L Roberts, RN

Role: primary

teresa.roberts@louisville.edu

502-333-6934

Other Identifiers

BCC-RAD-13-Pentoxifylline

Identifier Type: -

Identifier Source: org_study_id