Assessing the safety of pentoxifylline and SABR for lung cancer treatment
Effect of Pentoxifylline and Vitamin E in Preventing Radiation-induced Toxicity in the Treatment of Recurrent or New Primary NSCLC Using Stereotactic Ablative Radiotherapy in Patients Previously Treated With Thoracic Radiation
This study is testing if combining a medication called pentoxifylline with a type of targeted radiation therapy can help people with recurrent lung cancer feel better and live longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 59 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Louisville Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Louisville, Kentucky) |
| Trial ID | NCT01871454 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial aims to evaluate the safety and effectiveness of combining pentoxifylline with stereotactic ablative radiotherapy (SABR) in patients with recurrent or new non-small cell lung cancers. Participants will undergo imaging and pulmonary function tests to confirm eligibility before receiving the treatment. The study focuses on patients who have previously been treated for thoracic malignancies and are experiencing loco-regional recurrence. The goal is to determine if this combination therapy can improve outcomes for these patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a history of thoracic malignancy and a new or recurrent lung cancer within the previously irradiated area.
Not a fit: Patients with lung cancers that are not recurrent or new within the previously treated area may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new option for patients with recurrent lung cancers, potentially improving their prognosis.
How similar studies have performed: While this approach is being explored in this trial, similar studies have shown promise in combining radiotherapy with adjunctive therapies for cancer treatment.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Louisville, Kentucky
- James Graham Brown Cancer Center, U of Louisville — Louisville, Kentucky, United States (Recruiting)
Study contacts
- Principal investigator: Neal E Dunlap, MD — James Graham Brown Cancer Center-U of Louisville
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.