Clinical trial · Interventional
Safety of Pentoxifylline and Vitamin E With Stereotactic Ablative Radiotherapy (SABR) in Non-small Cell Lung Cancers
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
NCT01871454CI-TRIAL-00073779unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancers | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pentoxifylline | Drug | — | UNRESOLVED |
| stereotactic ablative radiotherapy (SABR) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- radiotherapy (SABR) plus pentoxifylline
- description
- standard of care radiotherapy (SABR) plus pentoxifylline and Vitamin E
- interventionNames
- Radiation: stereotactic ablative radiotherapy (SABR)
- Drug: Pentoxifylline
Primary outcomes (1)
- measure
- primary endpoint is to estimate overall treatment-related toxicity
- timeFrame
- 36 months-end of trial
Secondary outcomes (3)
- measure
- Estimate progression free survival
- timeFrame
- 12 months
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.