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SUNSET: SBRT for Ultra-central NSCLC- a Safety and Efficacy Trial

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ClinicalTrials.gov Identifier: NCT03306680
Recruitment Status : Recruiting
First Posted : October 11, 2017
Last Update Posted : November 30, 2018
Sponsor:
Information provided by (Responsible Party):
David Palma, Lawson Health Research Institute

Brief Summary:

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

Detailed Description:

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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

Radiation: SBRT
Patients will be assigned to treatment doses using the TITE-CRM model.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Time to Local Progression [ Time Frame: 3-5 years ]
  2. Regional nodal progression [ Time Frame: 3-5 years ]
    Defined as presence of enlarged lymph nodes >1 cm [short axis] in the hilum or mediastinum.

  3. Time to distant metastases [ Time Frame: 3-5 years ]
  4. Progression-Free Survival [ Time Frame: 3-5 years ]
  5. Overall survival [ Time Frame: 3-5 years ]
  6. Patient reported outcome [ Time Frame: Before treatment & at 3, 6, 9, 12, 18, 24, 36, 48, and 60 months ]
    FACT-L

  7. Quality of Life [ Time Frame: Before treatment & at 3, 6, 9, 12, 18, 24, 36, 48, and 60 months ]
    EQ-5D-5L



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Pathologically (histologically or cytologically) proven diagnosis of non-small cell lung cancer (NSCLC); if the risk of biopsy is unacceptable, pathologic confirmation is not required providing there is serial growth on serial (>=2) CT imaging and/or FDG avidity that is strongly suggestive of a primary NSCLC.
  2. Stage T1-3, N0, M0 (UICC/AJCC Staging, 8th Ed.), tumor size < 6 cm, prior to registration, based upon the following minimum diagnostic workup:

    1. History/physical examination within 4 weeks prior to registration
    2. CT scan with contrast (unless medically contraindicated) within 12 weeks of registration. The CT scan will include the entirety of both lungs, the mediastinum, liver and adrenal glands; the primary tumor dimensions will be measured on CT. Note: Patients with lesions that cannot be visualized by CT scan are not eligible for the study.
    3. Whole body positron emission tomography (PET) scan within 12 weeks of registration, using FDG with adequate visualization of the primary tumor and draining lymph node basins in the hilar and mediastinal regions.
    4. Mediastinal lymph node sampling by any technique is encouraged but not required. Patients with hilar or mediastinal lymph nodes <1 cm and no abnormal hilar or mediastinal uptake on PET will be considered N0. Patients with > 1 cm hilar or mediastinal lymph nodes on CT or abnormal PET (including suspicious but nondiagnostic uptake) may still be eligible if directed tissue biopsies of all abnormally identified areas are negative for cancer.
  3. ECOG performance status 0-2;
  4. age >18;
  5. Ultra-central tumor location: tumours whose planning target volume (PTV) is expected to touch or overlaps the central bronchial tree, esophagus, pulmonary vein, or pulmonary artery as determined at the time of consultation.

Exclusion Criteria:

  1. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (e.g. carcinomas in situ of the breast, oral cavity, or cervix are permissible); previous lung cancer, if the patient is disease-free for a minimum of 2 years is permitted.
  2. Any prior thoracic radiotherapy.
  3. Any prior chemotherapy for the study cancer (cancer proposed to be treated on the study).
  4. Prior surgery for the study cancer.
  5. Plans for the patient to receive other local therapy (including standard fractionated radiotherapy and/or surgery) while on this study, except at disease progression;
  6. Plans for the patient to receive systemic therapy (including standard chemotherapy or biologic targeted agents), while on this study, except at disease progression.
  7. Pregnancy.
  8. The following autoimmune and connective tissue diseases will be excluded: Scleroderma and Systemic lupus erythematosus
  9. patients with interstitial lung disease (ILD).

Information from the National Library of Medicine

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


Contacts
Contact: David Palma, MD 519-685-8650 david.palma@lhsc.on.ca
Contact: Meredith Giuliani, MBBS, FRCPC 416-946-2983 meredith.giuliani@rmp.uhn.ca

Locations
Canada, Ontario
London Regional Cancer Program Recruiting
London, Ontario, Canada, N6A 4L6
Contact: Anne O'Connell    519-685-8618    anne.oconnell@lhsc.on.ca   
Contact: James Sinfield    519-685-8618    james.sinfield@lhsc.on.ca   
Principal Investigator: David Palma         
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 1X6
Contact: Andrew Hope, MD, FRCPC    416-946-2124    andrew.hope@rmp.uhn.ca   
Contact: Lea Dungao    416 946 4501    Lea.Dungao@rmp.uhn.ca   
Canada, Quebec
Centre Hospitalier de l'Universite de Montreal (CHUM) Recruiting
Montréal, Quebec, Canada, H2X 0A9
Contact: Diane Trudel, RN    514-890-8000 ext 26906    diane.dt.trudel.chum@ssss.gouv.qc.ca   
Principal Investigator: Edith Filion, MD FRCPC         
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Meredith Giuliani, MBBS, FRCPC Princess Margaret Cancer Center

Responsible Party: David Palma, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT03306680     History of Changes
Other Study ID Numbers: SUNSET
First Posted: October 11, 2017    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases