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SABR + Pentoxifylline/Vitamin E for Lung Cancer
Phase 2
Recruiting
Led By Neal E Dunlap, MD
Research Sponsored by University of Louisville
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status 0-1
Age >/= 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months-end of trial
Awards & highlights
Study Summary
This trial is testing a combination of drugs to see if they are effective and have few side effects in treating people with lung cancer that has come back or spread.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include typical reactions to radiotherapy like skin irritation, fatigue, difficulty swallowing if the esophagus is affected, as well as possible risks associated with Pentoxifylline such as dizziness, nausea, or gastrointestinal upset.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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I am 18 years old or older.
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I had cancer in my chest area treated with radiation, with or without chemotherapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 months-end of trial
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months-end of trial
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
primary endpoint is to estimate overall treatment-related toxicity
Secondary outcome measures
Estimate progression free survival
Estimate tumor failure
estimate overall survival
Trial Design
1Treatment groups
Experimental Treatment
Group I: radiotherapy (SABR) plus pentoxifyllineExperimental Treatment2 Interventions
standard of care radiotherapy (SABR) plus pentoxifylline and Vitamin E
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pentoxifylline
FDA approved
Find a Location
Who is running the clinical trial?
University of LouisvilleLead Sponsor
338 Previous Clinical Trials
75,925 Total Patients Enrolled
James Graham Brown Cancer CenterOTHER
43 Previous Clinical Trials
9,159 Total Patients Enrolled
Neal E Dunlap, MDPrincipal InvestigatorJames Graham Brown Cancer Center-U of Louisville
2 Previous Clinical Trials
40 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or can carry out light work.I haven't had chemotherapy in the last 4 weeks.My lung cancer is newly diagnosed or has come back in the same area.I have never had radiation therapy to my chest.I will be receiving chemotherapy at the same time as radiotherapy.I am 18 years old or older.I had cancer in my chest area treated with radiation, with or without chemotherapy.Your lung function test results are very low, showing that you have severe breathing problems.
Research Study Groups:
This trial has the following groups:- Group 1: radiotherapy (SABR) plus pentoxifylline
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Do you have any current openings for this research project?
"From what is published on clinicaltrials.gov, it seems that this clinical trial is still searching for participants. The study was first posted on October 1st, 2013 and was most recently edited on June 21st, 2021."
Answered by AI
Is SABR a viable option for cancer patients in the United States?
"While there is some evidence that stereotactic ablative radiotherapy (SABR) is safe, as this is only a phase 2 trial, there is currently no data to support its efficacy."
Answered by AI
What are the most popular treatments that use SABR?
"SABR can be an effective treatment for various disorders and diseases, such as: alcoholic liver diseases, venous leg ulcer (vlu), and intermittent claudication."
Answered by AI
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