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



Status:Recruiting
Conditions:Lung Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/7/2018
Start Date:October 2013
End Date:December 2018

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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


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
We found this trial at
1
site
Louisville, Kentucky 40202
Phone: 502-333-6934
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Louisville, KY
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