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
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
Drug | Synonyms | Arms |
---|
Pentoxifylline | | radiotherapy (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
Name | Type | Description | Interventions |
---|
radiotherapy (SABR) plus pentoxifylline | Experimental | standard of care radiotherapy (SABR) plus pentoxifylline and Vitamin E | |
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