Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04782752
Status:
RECRUITING
Last Update Posted:
2023-12-11
First Post:
2021-03-01
Brief Title:
Non-ablative Oligofractionated Radiation Therapy Before Surgical Transplantation As Radiovaccination
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Non-ablative Oligofractionated Radiation Therapy Before Surgical Transplantation As Radiovaccination
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NORTh STAR
Brief Summary:
This is a prospective phase I study to determine the safety and feasibility of non-ablative oligofractionated radiation therapy NORT before lung transplantation for patients with underlying pulmonary malignancy We hypothesize that heterogeneous dose distributions could generate a vaccination effect against the tumor by creating anti-tumoral immune response in the body and these patients may be immunized against their tumor which could reduce the risk of cancer recurrence after transplantation despite the anti-rejection medications required for the transplantation
Detailed Description:
This study is designed to deliver short courses of radiation to the pulmonary malignancy followed by resection of the radiated tumor at the time of transplant
The study is a 33 phase 1 study with incremental dose of radiation to determine the maximum tolerated dose MTD Dose limiting toxicity DLT will be defined as grade 3 radiation related toxicity If one DLT is seen then an additional 3 patients will be treated at the same dose level If 2 or more DLT are seen at any given dose level then the previous dose level will be defined as the MTD A minimum of 3 patients and maximum of 18 patients will be included for the phase 1a Due to the expected higher radiation risks in patients with end-stage ILD group 1 these patients will be stratified separately from non-ILD patients group 2 3 and 4 during phase 1a Dose tested are 3 x 400 cGy 3 x 600 cGy and 3 x 800 cGy for the ILD cohort and 3 x 800 cGy 3 x 1000 cGy and 3 x 1200 cGy for the non-ILD cohort
Once the MTD is determined patients will proceed to phase 1b using the MTD determined in the phase 1a ILD and non-ILD patients may have different MTD so two separate phase Ib cohorts will be conducted A total of 12 patients will be included for each cohort in the phase 1b The dose distribution will be administered using a standard homogenous dose distribution for tumors 2 cm and an heterogeneous dose distribution for tumors 2 cm
The study is a 33 phase 1 study with incremental dose of radiation to determine the maximum tolerated dose MTD Dose limiting toxicity DLT will be defined as grade 3 radiation related toxicity If one DLT is seen then an additional 3 patients will be treated at the same dose level If 2 or more DLT are seen at any given dose level then the previous dose level will be defined as the MTD A minimum of 3 patients and maximum of 18 patients will be included for the phase 1a Due to the expected higher radiation risks in patients with end-stage ILD group 1 these patients will be stratified separately from non-ILD patients group 2 3 and 4 during phase 1a Dose tested are 3 x 400 cGy 3 x 600 cGy and 3 x 800 cGy for the ILD cohort and 3 x 800 cGy 3 x 1000 cGy and 3 x 1200 cGy for the non-ILD cohort
Once the MTD is determined patients will proceed to phase 1b using the MTD determined in the phase 1a ILD and non-ILD patients may have different MTD so two separate phase Ib cohorts will be conducted A total of 12 patients will be included for each cohort in the phase 1b The dose distribution will be administered using a standard homogenous dose distribution for tumors 2 cm and an heterogeneous dose distribution for tumors 2 cm
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None