Pentoxifylline + Vitamin E for Non-Small Cell Lung Cancer (P4-PACIFIC Trial)

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University Health Network, Toronto

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults with stage III non-small cell lung cancer who can't have surgery and are about to start chemoradiation. They should not have had previous radiation therapy in the chest area or be taking other drugs that affect blood clotting.

Treatment Details

The study tests if Pentoxifylline combined with α-Tocopherol (Vitamin E) can prevent or lessen lung injury from radiation in patients undergoing standard chemoradiation treatment, compared to a placebo group.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Experimental ArmExperimental Treatment2 Interventions

Participants in the experimental arm will start Pentoxifylline 400 mg orally three times a day and α-Tocopherol 400 IU orally two times a day on day one of radiotherapy and continue treatment for 6 months.

Group II: Control ArmPlacebo Group1 Intervention

Participants in the control arm will start 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.