Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06634056
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-07
Brief Title:
Pneumonitis Prevention Protocol Using Pentoxifylline and Α-tocopherol in Stage III Non-Small Cell Lung Cancer Patients Undergoing Chemoradiation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pneumonitis Prevention Protocol Using Pentoxifylline and Α-tocopherol in Stage III Non-Small Cell Lung Cancer Patients Undergoing Chemoradiation P4-PACIFIC
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
P4-PACIFIC
Brief 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 andor 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 ie RT chemotherapy and ICI The drug Pentoxifylline in combination with α-Tocopherol Vitamin E has been shown to preventalter 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
Detailed Description:
This is a multi-centre Phase II double-blind placebo-controlled randomized trial Eligible participants will include newly diagnosed inoperable Stage III patients with NSCLC who will be treated with radical intent concurrent chemoradiation therapy with planned consolidation immune checkpoint inhibitor ICI as per standard of care Participants will be randomized in a 11 ratio between control arm Placebos for 6 months Arm 1 and the experimental arm Pentoxifyllineα-Tocopherol for 6 months Arm 2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None