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| Name | Class |
|---|---|
| James Graham Brown Cancer Center | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| radiotherapy (SABR) plus pentoxifylline | Experimental | standard of care radiotherapy (SABR) plus pentoxifylline and Vitamin E |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stereotactic ablative radiotherapy (SABR) | Radiation | standard of care radiation therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| primary endpoint is to estimate overall treatment-related toxicity | 36 months-end of trial |
| Measure | Description | Time Frame |
|---|---|---|
| Estimate progression free survival | 12 months | |
| Estimate tumor failure | 12 months | |
| estimate overall survival |
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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)
3.1.5 Imaging as follows:
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
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| Name | Affiliation | Role |
|---|---|---|
| Neal E Dunlap, MD | James Graham Brown Cancer Center-U of Louisville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James Graham Brown Cancer Center, U of Louisville | Recruiting | Louisville | Kentucky | 40202 | United States |
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| ID | Term |
|---|---|
| D010431 | Pentoxifylline |
| ID | Term |
|---|---|
| D013805 | Theobromine |
| D014970 | Xanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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| Pentoxifylline | Drug | pentoxifylline |
|
| 12 months |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |