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NOT YET RECRUITING
NCT06634056
PHASE2

Pneumonitis Prevention Protocol Using Pentoxifylline and α-tocopherol In Stage III Non-Small Cell Lung Cancer Patients Undergoing Chemoradiation

Sponsor: University Health Network, Toronto

View on ClinicalTrials.gov

Summary

Currently, the standard of care treatment for newly diagnosed, inoperable stage III non-small cell lung cancer is radiotherapy (RT) with concurrent chemotherapy, followed by immune checkpoint inhibitors (ICI). RT is a highly effect local treatment. However, high doses of radiation used in curative settings can cause adverse side effects. The most common RT side effect in lung cancer is Radiation Induced Lung Injury (RILI), which can manifest as pneumonitis and/or pulmonary fibrosis. Lung injury can negatively impact patients' well-being and quality of life, and may lead to increased mortality. Risk of lung injury is particularly increased when patients are treated with a combination of treatments (i.e., RT, chemotherapy, and ICI). The drug Pentoxifylline (in combination with α-Tocopherol (Vitamin E)) has been shown to prevent/alter the progression of lung injury and there is a growing body of evidence to support the safety and efficacy of phosphodiesterase inhibitors in cancer treatment. The proposed study aims to determine if the addition of Pentoxifylline, given in combination with α-Tocopherol (Vitamin E), to standard of care treatment will reduce side effects related to lung injury and improve quality of life in this study population.

Official title: Pneumonitis Prevention Protocol Using Pentoxifylline and α-tocopherol in Stage III Non-Small Cell Lung Cancer Patients Undergoing Chemoradiation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2026-05-30

Completion Date

2032-11-30

Last Updated

2026-03-04

Healthy Volunteers

No

Interventions

DRUG

Pentoxifylline

Pentoxifylline 400 mg orally three times a day and α-Tocopherol IU orally two times a day on day one of radiotherapy and continue treatment for 6 months.

OTHER

Placebo

One placebo orally three times a day and another placebo orally two times a day on day one of radiotherapy and continue treatment for 6 months.

OTHER

α-Tocopherol

Pentoxifylline 400 mg orally three times a day and α-Tocopherol IU orally two times a day on day one of radiotherapy and continue treatment for 6 months.

Locations (1)

University Health Network - Princess Margaret Cancer Centre

Toronto, Ontario, Canada