SABR + Pentoxifylline/Vitamin E for Lung Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University of Louisville
Disqualifiers: No prior thoracic radiotherapy, Pregnancy, Recent chemotherapy, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?This trial is testing a combination of a blood flow medication and precise radiation therapy on patients with recurring or new lung cancers. The goal is to see if this combination is safe and effective.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot have had chemotherapy within 4 weeks before starting the trial, and you cannot have plans to take chemotherapy at the same time as the trial treatment.
What data supports the effectiveness of the treatment SABR + Pentoxifylline/Vitamin E for lung cancer?
Research shows that stereotactic ablative radiotherapy (SABR) is effective for treating small lung tumors and early-stage non-small cell lung cancer (NSCLC), with favorable results and low toxicity. This suggests that SABR, as part of the combined treatment, could be beneficial for lung cancer patients.
12345Is the combination of SABR, Pentoxifylline, and Vitamin E safe for humans?
Research suggests that the combination of pentoxifylline and vitamin E is generally safe and may reduce radiation-induced lung toxicity in lung cancer patients. In studies, this combination was well-tolerated and did not commonly cause patients to stop treatment due to side effects.
678910How does the SABR + Pentoxifylline/Vitamin E treatment for lung cancer differ from other treatments?
This treatment combines stereotactic ablative radiotherapy (a precise form of radiation therapy) with pentoxifylline and vitamin E, which may reduce radiation-induced lung damage and improve survival rates compared to radiotherapy alone.
6781112Eligibility Criteria
This trial is for adults over 18 with a history of thoracic cancer treated previously, who now have new or recurrent lung malignancies. They should be in good physical condition (ECOG 0-1), not pregnant, willing to use birth control, and have had recent scans and pulmonary tests. Those with very poor lung function or recent chemotherapy are excluded.Inclusion Criteria
I am fully active or can carry out light work.
My lung cancer is newly diagnosed or has come back in the same area.
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, Pulmonary function test (PFTs), including diffusion capacity within 8 weeks of registration, Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential, Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control, Patients must provide study specific informed consent prior to study entry.
+2 more
Exclusion Criteria
I haven't had chemotherapy in the last 4 weeks.
I have never had radiation therapy to my chest.
I will be receiving chemotherapy at the same time as radiotherapy.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive stereotactic ablative radiotherapy (SABR) along with pentoxifylline and Vitamin E
6-8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
12 weeks
Participant Groups
The study is examining the safety and effectiveness of combining Pentoxifylline medication with Stereotactic Ablative Radiotherapy (SABR) for treating new or returning lung cancers that were previously irradiated.
1Treatment groups
Experimental Treatment
Group I: radiotherapy (SABR) plus pentoxifyllineExperimental Treatment2 Interventions
standard of care radiotherapy (SABR) plus pentoxifylline and Vitamin E
Pentoxifylline is already approved in United States, Canada, European Union for the following indications:
πΊπΈ Approved in United States as Trental for:
- Intermittent claudication
π¨π¦ Approved in Canada as Trental for:
- Intermittent claudication
πͺπΊ Approved in European Union as Trental for:
- Intermittent claudication
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
James Graham Brown Cancer Center, U of LouisvilleLouisville, KY
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Who Is Running the Clinical Trial?
University of LouisvilleLead Sponsor
James Graham Brown Cancer CenterCollaborator
References
Stereotactic ablative radiotherapy for small lung tumors with a moderate dose. Favorable results and low toxicity. [2022]Stereotactic ablative body radiotherapy (SBRT, SABR) is being increasingly applied because of its high local efficacy, e.g., for small lung tumors. However, the optimum dosage is still under discussion. Here, we report data on 45 lung lesions [non-small cell lung cancer (NSCLC) or metastases] in 39 patients treated between 2009 and 2010 by SABR.
Stereotactic ablative radiation therapy for pulmonary metastases: Improving overall survival and identifying subgroups at high risk of local failure. [2021]Stereotactic ablative radiation therapy (SABR) is an emerging treatment option for patients with pulmonary metastases; identifying patients who would benefit from SABR can improve outcomes.
SABRTooth: a randomised controlled feasibility study of stereotactic ablative radiotherapy (SABR) with surgery in patients with peripheral stage I nonsmall cell lung cancer considered to be at higher risk of complications from surgical resection. [2022]Stereotactic ablative radiotherapy (SABR) is a well-established treatment for medically inoperable peripheral stage I nonsmall cell lung cancer (NSCLC). Previous nonrandomised evidence supports SABR as an alternative to surgery, but high-quality randomised controlled trial (RCT) evidence is lacking. The SABRTooth study aimed to establish whether a UK phase III RCT was feasible.
Stereotactic ablative radiation therapy in lung cancer: an emerging standard. [2019]Significant advances have been made in the field of stereotactic ablative radiotherapy (SABR) for the treatment of pulmonary neoplasms in recent years. This review aims to summarize recent salient evidence on SABR for early-stage nonsmall cell lung cancer (ES-NSCLC).
Partial stereotactic ablative boost radiotherapy in bulky non-small cell lung cancer: a retrospective study. [2022]Bulky non-small cell lung cancer (NSCLC) is difficult to achieve effective local control by conventionally fractionated radiotherapy (CRT). The present work aims to evaluate the safety and efficacy of partial stereotactic ablative boost radiotherapy (P-SABR) in bulky NSCLC.
Pentoxifylline and alpha-tocopherol in prevention of radiation-induced lung toxicity in patients with lung cancer. [2019]Combined use of pentoxifylline and vitamin E is reported to reduce radiation-induced toxicity in normal tissues at molecular level. We plan to evaluate the role of combined use of pentoxifylline (PTX) and alpha-tocopherol (vitamin E; Vit E) for minimizing radiation-induced lung toxicity. A total of 91 lung cancer patients were randomized. Among them, 44 received PTX (400 mg three times a day orally and Vit E 300 mg twice a day orally during the entire period of radiotherapy. PTX and Vit E were further administered at doses of 400 mg once a day and 300 mg once a day, respectively for 3 months after radiotherapy. A total of 47 patients were assigned as a control group. Radiation related acute and late toxicities are evaluated by radiation RTOG/EORTC toxicity scale. Median age was 59 (range, 41-75). Median follow-up was 13 months (range, 3-28 months). Radiation-induced lung toxicity was more frequent in control group for all phases than in pentoxifylline and alpha-tocopherol group (acute phase, P = 0.042, subacute phase P = 0.0001, late phase P = 0.256). PTX and Vit E combination might be considered especially in patients with lung cancer who receive concurrent chemo-radiotherapy, or have a poor respiratory function tests.
A randomized prospective study of extended tocopherol and pentoxifylline therapy, in addition to carbogen, in the treatment of radiation late effects. [2021]pentoxifylline (PTX) and tocopherol (vitamin E) are antioxidants previously shown to be useful in combination in the treatment of late radiation induced toxicity. The purpose of this study was to investigate the benefit of combination therapy with carbogen pentoxifylline and tocopherol in the mitigation of late radiation effects. As the optimal duration of PTX and tocopherol treatment has not been fully established, we studied short versus extended treatment duration.
Vitamin E protects against the development of radiation-induced pulmonary fibrosis in rats. [2013]To investigate whether the application of vitamin E with or without pentoxifylline could modify the development of radiation-induced pulmonary fibrosis.
Kinetics of response to long-term treatment combining pentoxifylline and tocopherol in patients with superficial radiation-induced fibrosis. [2017]Significant regression of radiation (RT) -induced fibrosis (RIF) has been achieved after treatment combining pentoxifylline (PTX) and alpha-tocopherol (vitE). In this study, we focus on the maximum response, how long it takes to achieve response, and changes after treatment discontinuation.
A phase II evaluation of pentoxifylline combined with radiation in the treatment of brain metastases. [2013]Pentoxifylline (PTX) has pharmacological properties that suggest potential utility as a radiation sensitizer, and preclinical animal studies have been promising. In a non-randomized phase II trial, we used PTX plus standard-dose external-beam whole-brain radiation treatment (WBRT) in patients with brain metastases. Seventeen patients were entered; 14 received both WBRT and PTX and were considered evaluable. Nine of the 14 completed treatment. Analyzing data on all 14 evaluable patients according to intent to treat, median survival time was 33 days, comparable to published data from historical controls. PTX toxicity was not a common cause of patient dropout, supporting higher PTX doses in future trials.
Effect of concomitant use of pentoxifylline and alpha-tocopherol with radiotherapy on the clinical outcome of patients with stage IIIB non-small cell lung cancer: a randomized prospective clinical trial. [2019]We evaluated the effects of pentoxifylline (PTX) and alpha-tocopherol on the clinical outcome of 66 patients with stage IIIB non-small cell lung cancer in a randomized clinical trial. All patients received 46 Gy of external radiotherapy to the primary tumor and regional lymph nodes, with an additional 14-Gy dose to the primary tumor. Thirty-three of the 66 patients also received PTX (400 mg, three times daily) and alpha-tocopherol (300 mg, twice daily) during radiotherapy, followed by 400 mg of PTX and 300 mg of alpha-tocopherol daily for 3 mo after radiotherapy. The remaining 33 patients (control group) received radiotherapy only. After a mean follow-up time of 12 mo, 18 patients remained alive. During follow-up, there were local recurrences in 14 patients and distant metastases in 18 patients. In patients who received PXT and alpha-tocopherol, 1- and 2-yr overall survival rates were 55% and 30%, respectively, and median survival was 18 mo. In control patients, 1- and 2-yr overall survival rates were 40% and 14%, respectively, with a median survival of 10 mo. These differences were statistically significant (p = 0.0175). In patients who received PXT and alpha-tocopherol, progression-free survival rates for 1 and 2 yr were 48% and 23%, respectively; median survival was 12 mo. In the control group, the corresponding rates were 24% and 18%; median survival was 8 mo (p = 0.0223). We conclude that the use of PTX and alpha-tocopherol combined with radiotherapy offers a possible survival advantage in this patient population.
Management of bisphosphonate-associated osteonecrosis: pentoxifylline and tocopherol in addition to antimicrobial therapy. An initial case series. [2013]Studies of the use of pentoxifylline and Ξ±-tocopherol in osteoradionecrosis of the jaw have suggested their efficacy in this condition. We report an initial case series of pentoxifylline and Ξ±-tocopherol for patients with bisphosphonate-associated osteonecrosis (BON).