Non-ablative Oligofractionated Radiation Therapy Before Surgical Transplantation As Radiovaccination (NORTh STAR)
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|ClinicalTrials.gov Identifier: NCT04782752|
Recruitment Status : Recruiting
First Posted : March 4, 2021
Last Update Posted : May 4, 2021
|Condition or disease||Intervention/treatment||Phase|
|Transplant-Related Lung Cancer||Radiation: Radiation: Varying Doses of RT||Not Applicable|
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 3+3 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||3+3 radiation dose escalation|
|Masking:||None (Open Label)|
|Official Title:||Non-ablative Oligofractionated Radiation Therapy Before Surgical Transplantation As Radiovaccination|
|Actual Study Start Date :||March 30, 2021|
|Estimated Primary Completion Date :||December 2025|
|Estimated Study Completion Date :||December 2025|
Experimental: Experimental: Radiation
Patients will be differentiated into 4 groups:
For this study, different doses will be used for each different group depending on their tumour size. The first 3 patients will start with a dose of 4 Gy, for the ILD group, or 8 Gy, for the non ILD group. The doses are then increased incrementally until the dose limiting toxicity is reached.
Radiation: Radiation: Varying Doses of RT
3+3 radiation dose escalation model to see the maximum tolerated dose
- Maximum Tolerated Dose for Radiation [ Time Frame: Up to four years ]
AEs will be graded by CTCAE. Maximum tolerated dose is the dose level do not result in fatal injury (grade 5 lung toxicity) or life-threatening or fatal treatment related toxicity (grade 4+).
Safety will be determined by the absence of grade 3 or greater (G3+) complications related to radiation and the feasibility to list patients for transplantation one week after the end of radiation will be determined.
- Patient Morbidity [ Time Frame: Up to four years ]NCI common toxicity scale
- Local recurrence [ Time Frame: Up to four years ]Documented radiographically
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04782752
|Contact: Marc de Perrot, MD, MSc||416 firstname.lastname@example.org|
|Contact: John Cho, MD, PhD||416-946-4501 ext 6513||John.Cho@rmp.uhn.ca|