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The Effect of Pentoxifylline in Preventing Radiation-induced Toxicity in the Treatment of Recurrent or New Primary Non-small Cell Lung Cancers Using Stereotactic Ablative Radiotherapy (SABR) in Patients Previously Treated With Thoracic Radiation


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-small Cell Lung Cancers

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Trial Information

The Effect of Pentoxifylline in Preventing Radiation-induced Toxicity in the Treatment of Recurrent or New Primary Non-small Cell Lung Cancers Using Stereotactic Ablative Radiotherapy (SABR) in Patients Previously Treated With Thoracic Radiation


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

primary endpoint is to estimate overall treatment-related toxicity

Outcome Time Frame:

36 months-end of trial

Safety Issue:

Yes

Principal Investigator

Neal E Dunlap, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

James Graham Brown Cancer Center-U of Louisville

Authority:

United States: Institutional Review Board

Study ID:

BCC-RAD-13-Pentoxifylline

NCT ID:

NCT01871454

Start Date:

October 2013

Completion Date:

October 2016

Related Keywords:

  • Non-small Cell Lung Cancers
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

James Graham Brown Cancer Center, U of Louisville Louisville, Kentucky  40202