Recruiting
Phase 2

Pentoxifylline & SABR

Sponsor:

University of Louisville

Code:

NCT01871454

Conditions

Non-small Cell Lung Cancers

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

stereotactic ablative radiotherapy (SABR)

Pentoxifylline

Study Details

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 ID

NCT01871454

Start date

Oct, 2013

Status verified date

Feb, 2024

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

59 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: radiotherapy (SABR) plus pentoxifylline

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

Interventions

stereotactic ablative radiotherapy (SABR)

standard of care radiation therapy

Pentoxifylline

pentoxifylline

Primary outcome measure

  • primary endpoint is to estimate overall treatment-related toxicity [ Time Frame: 36 months-end of trial ]

Central Contacts and Locations

Locations

James Graham Brown Cancer Center, U of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

More Information

Sponsor

University of Louisville

Last update posted

Feb 7, 2024

Last verified

Feb, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Louisville on 2024-02-07.