SUNSET: SBRT for Ultra-central NSCLC- a Safety and Efficacy Trial
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03306680|
Recruitment Status : Recruiting
First Posted : October 11, 2017
Last Update Posted : November 30, 2018
This multi-centre phase I dose-escalation study will use a time-to-event continual reassessment method (TIT-CRM).
Accrual will start at level 1 (60 Gy in 8 fractions). Patients will be assigned to treatment doses using the TITE-CRM model. The model will use all available information from previously accrued patients to assign the highest dose with a predicted risk of grade 3 toxicity of 30% or less.
|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer||Radiation: SBRT||Phase 1|
This study will use a time-to-event continual reassessment method (TITE-CRM). The study design is based on RTOG 0813 (described above), but with a more cautious approach, since the patients herein may constitute a high-risk subset of the patients enrolled in RTOG 0813. The modifications include a starting dose (60 Gy in 8 fractions) herein that is lower than the safe dose for central tumors as determined by RTOG 0813 (60 Gy in 5 fractions), and longer follow-up period during which patients are considered at-risk for toxicity, (i.e. two years herein vs. one year in RTOG 0813).
The primary endpoint of this study is the maximally tolerated dose (MTD) of radiotherapy for ultracentral tumors. The MTD is the dose of radiotherapy associated with a <30% rate of grade 3-5 toxicity occurring within 2 years of treatment.
Local Progression, Regional nodal progression, Distant metastases, Progression-Free Survival, Overall survival, patient reported outcomes and quality of life.
The correlative objectives of this study are to determine the prognostic value of ctDNA levels measured pre-treatment, at the end of treatment and 3- and 12-months after treatment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||SUNSET: SBRT for Ultra-central NSCLC- a Safety and Efficacy Trial|
|Actual Study Start Date :||January 19, 2018|
|Estimated Primary Completion Date :||October 2022|
|Estimated Study Completion Date :||October 2022|
Experimental: Patients with ultra-central NSCLC T1-3 (<6cm) N0 M0
Level-1 Dose per fraction: 4Gy Number of fractions: 15 Total Dose: 60 Gy
Level 0 Dose per fraction: 6Gy Number of fractions: 10 Total Dose: 60 Gy
Level 1 Dose per fraction: 7.5 Gy Number of fractions: 8 Total Dose: 60 Gy
Level 2 Dose per fraction: 10 Gy Number of fractions: 6 Total Dose: 60 Gy
Level 3 Dose per fraction: 12 Gy Number of fractions: 5 Total Dose: 60 Gy
Patients will be assigned to treatment doses using the TITE-CRM model.
- Maximally tolerated dose (MTD) [ Time Frame: Occurring within 2 years of treatment ]MTD of radiotherapy for ultracentral tumors. The MTD is the dose of radiotherapy associated with a <30% rate of grade 3-5 toxicity occurring within 2 years of treatment.
- Time to Local Progression [ Time Frame: 3-5 years ]
- Regional nodal progression [ Time Frame: 3-5 years ]Defined as presence of enlarged lymph nodes >1 cm [short axis] in the hilum or mediastinum.
- Time to distant metastases [ Time Frame: 3-5 years ]
- Progression-Free Survival [ Time Frame: 3-5 years ]
- Overall survival [ Time Frame: 3-5 years ]
- Patient reported outcome [ Time Frame: Before treatment & at 3, 6, 9, 12, 18, 24, 36, 48, and 60 months ]FACT-L
- Quality of Life [ Time Frame: Before treatment & at 3, 6, 9, 12, 18, 24, 36, 48, and 60 months ]EQ-5D-5L
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): NCT03306680
|Contact: David Palma, MDemail@example.com|
|Contact: Meredith Giuliani, MBBS, FRCPCfirstname.lastname@example.org|
|London Regional Cancer Program||Recruiting|
|London, Ontario, Canada, N6A 4L6|
|Contact: Anne O'Connell 519-685-8618 email@example.com|
|Contact: James Sinfield 519-685-8618 firstname.lastname@example.org|
|Principal Investigator: David Palma|
|Princess Margaret Cancer Centre||Recruiting|
|Toronto, Ontario, Canada, M5G 1X6|
|Contact: Andrew Hope, MD, FRCPC 416-946-2124 email@example.com|
|Contact: Lea Dungao 416 946 4501 Lea.Dungao@rmp.uhn.ca|
|Centre Hospitalier de l'Universite de Montreal (CHUM)||Recruiting|
|Montréal, Quebec, Canada, H2X 0A9|
|Contact: Diane Trudel, RN 514-890-8000 ext 26906 firstname.lastname@example.org|
|Principal Investigator: Edith Filion, MD FRCPC|
|Principal Investigator:||Meredith Giuliani, MBBS, FRCPC||Princess Margaret Cancer Center|