Non-small Cell Lung CancersPhase 2NCT01871454
Safety of Pentoxifylline and Vitamin E With Stereotactic Ablative Radiotherapy (SABR) in Non-small Cell Lung Cancers
A Phase 2 study testing stereotactic ablative radiotherapy (SABR) and Pentoxifylline in people with Non-small Cell Lung Cancers, run by University of Louisville at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancers
- What is being tested?
- stereotactic ablative radiotherapy (SABR) and Pentoxifylline
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
James Graham Brown Cancer Center, U of Louisville
Louisville, Kentucky, 40202
Teresa L Roberts, RN, 502-333-6934, teresa.roberts@louisville.edu
About this study
Official title: 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
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
- Being tested
- stereotactic ablative radiotherapy (SABR), Pentoxifylline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stereotactic ablative radiotherapy (SABR)Radiation
standard of care radiation therapy
PentoxifyllineDrug
pentoxifylline
| Study group | Role | What they receive |
|---|---|---|
| radiotherapy (SABR) plus pentoxifylline | Experimental | standard of care radiotherapy (SABR) plus pentoxifylline and Vitamin E Receives: Radiation: stereotactic ablative radiotherapy (SABR); Drug: Pentoxifylline |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary endpoint is to estimate overall treatment-related toxicity
Measured: 36 months-end of trial
Secondary outcomes (3)
Estimate progression free survival
Measured: 12 months
Estimate tumor failure
Measured: 12 months
estimate overall survival
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancersStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- James Graham Brown Cancer Center
- Responsible party
- Principal investigator, Neal Edward Dunlap, University of Louisville
- Investigators
- Neal E Dunlap, MD, Principal investigator, James Graham Brown Cancer Center-U of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01871454
- Sponsor's protocol ID
- BCC-RAD-13-Pentoxifylline
- Status last verified
- Feb 2024
- First submitted
- 4 Jun 2013
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01871454
- Acronym / sponsor ID
- BCC-RAD-13-Pentoxifylline
- Conditions
- Non-small Cell Lung Cancers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- James Graham Brown Cancer Center
- Study start
- Oct 2013
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 6 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| radiotherapy (SABR) plus pentoxifylline | Experimental | Radiation: stereotactic ablative radiotherapy (SABR), Drug: Pentoxifyllinestandard of care radiotherapy (SABR) plus pentoxifylline and Vitamin E |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stereotactic ablative radiotherapy (SABR)standard of care radiation therapy | Radiation | radiotherapy (SABR) plus pentoxifylline |
| Pentoxifyllinepentoxifylline | Drug | radiotherapy (SABR) plus pentoxifylline |
Primary outcome
primary endpoint is to estimate overall treatment-related toxicity
Time frame: 36 months-end of trial
3 secondary outcomes
Estimate progression free survival
Time frame: 12 months
Estimate tumor failure
Time frame: 12 months
estimate overall survival
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Graham Brown Cancer Center, U of Louisville
Louisville, United States
Neal E Dunlap, MD principal investigator
James Graham Brown Cancer Center-U of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing stereotactic ablative radiotherapy (SABR) and Pentoxifylline in people with Non-small Cell Lung Cancers, run by University of Louisville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary endpoint is to estimate overall treatment-related toxicity (time frame: 36 months-end of trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.