Clinical Trials /

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

NCT01871454

Description:

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

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: BCC-RAD-13-Pentoxifylline
  • NCT ID: NCT01871454

Conditions

  • Non-small Cell Lung Cancers

Interventions

DrugSynonymsArms
Pentoxifyllineradiotherapy (SABR) plus pentoxifylline

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
radiotherapy (SABR) plus pentoxifyllineExperimentalstandard of care radiotherapy (SABR) plus pentoxifylline and Vitamin E
  • Pentoxifylline

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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:primary endpoint is to estimate overall treatment-related toxicity
Time Frame:36 months-end of trial
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Estimate progression free survival
Time Frame:12 months
Safety Issue:
Description:
Measure:Estimate tumor failure
Time Frame:12 months
Safety Issue:
Description:
Measure:estimate overall survival
Time Frame:12 months
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:James Graham Brown Cancer Center

Last Updated

November 21, 2016