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Safety of Pentoxifylline and Vitamin E With Stereotactic Ablative Radiotherapy (SABR) in Non-small Cell Lung Cancers

Primary Purpose

Non-small Cell Lung Cancers

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
stereotactic ablative radiotherapy (SABR)
Pentoxifylline
Sponsored by
University of Louisville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • James Graham Brown Cancer Center, U of LouisvilleRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

radiotherapy (SABR) plus pentoxifylline

Arm Description

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

Outcomes

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

Full Information

First Posted
June 4, 2013
Last Updated
June 21, 2021
Sponsor
University of Louisville
Collaborators
James Graham Brown Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01871454
Brief Title
Safety of Pentoxifylline and Vitamin E With Stereotactic Ablative Radiotherapy (SABR) in Non-small Cell Lung Cancers
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville
Collaborators
James Graham Brown Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancers

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
radiotherapy (SABR) plus pentoxifylline
Arm Type
Experimental
Arm Description
standard of care radiotherapy (SABR) plus pentoxifylline and Vitamin E
Intervention Type
Radiation
Intervention Name(s)
stereotactic ablative radiotherapy (SABR)
Intervention Description
standard of care radiation therapy
Intervention Type
Drug
Intervention Name(s)
Pentoxifylline
Intervention Description
pentoxifylline
Primary Outcome Measure Information:
Title
primary endpoint is to estimate overall treatment-related toxicity
Time Frame
36 months-end of trial
Secondary Outcome Measure Information:
Title
Estimate progression free survival
Time Frame
12 months
Title
Estimate tumor failure
Time Frame
12 months
Title
estimate overall survival
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neal E Dunlap, MD
Organizational Affiliation
James Graham Brown Cancer Center-U of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
James Graham Brown Cancer Center, U of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teresa L Roberts, RN
Phone
502-333-6934
Email
teresa.roberts@louisville.edu

12. IPD Sharing Statement

Learn more about this trial

Safety of Pentoxifylline and Vitamin E With Stereotactic Ablative Radiotherapy (SABR) in Non-small Cell Lung Cancers

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