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

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ClinicalTrials.gov Identifier: NCT01871454
Recruitment Status : Recruiting
First Posted : June 6, 2013
Last Update Posted : January 5, 2018
Sponsor:
Collaborator:
James Graham Brown Cancer Center
Information provided by (Responsible Party):
Neal Edward Dunlap, University of Louisville

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

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancers Radiation: stereotactic ablative radiotherapy (SABR) Drug: Pentoxifylline Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 59 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Experimental: radiotherapy (SABR) plus pentoxifylline
standard of care radiotherapy (SABR) plus pentoxifylline and Vitamin E
Radiation: stereotactic ablative radiotherapy (SABR)
standard of care radiation therapy

Drug: Pentoxifylline
pentoxifylline




Primary Outcome Measures :
  1. primary endpoint is to estimate overall treatment-related toxicity [ Time Frame: 36 months-end of trial ]

Secondary Outcome Measures :
  1. Estimate progression free survival [ Time Frame: 12 months ]
  2. Estimate tumor failure [ Time Frame: 12 months ]
  3. estimate overall survival [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01871454


Locations
United States, Kentucky
James Graham Brown Cancer Center, U of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Teresa L Roberts, RN    502-333-6934    teresa.roberts@louisville.edu   
Sponsors and Collaborators
University of Louisville
James Graham Brown Cancer Center
Investigators
Principal Investigator: Neal E Dunlap, MD James Graham Brown Cancer Center-U of Louisville

Responsible Party: Neal Edward Dunlap, Associate Professor, University of Louisville
ClinicalTrials.gov Identifier: NCT01871454     History of Changes
Other Study ID Numbers: BCC-RAD-13-Pentoxifylline
First Posted: June 6, 2013    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Vitamins
Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Pentoxifylline
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Radiation-Protective Agents
Vasodilator Agents
Free Radical Scavengers