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Stereotactic Ablative Radiotherapy for Oligo-Progressive Non Small Cell Lung Cancer (SUPPRESS-NSCLC)

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: NCT04405401
Recruitment Status : Recruiting
First Posted : May 28, 2020
Last Update Posted : February 21, 2021
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Houda Bahig, Centre hospitalier de l'Université de Montréal (CHUM)

Brief Summary:
A registry-based randomized screening phase II trial. A total of 68 patients with metastatic non small cell lung cancer on systemic therapy with oligoprogression to 1-5 extracranial lesions will be randomized using a 1:1 ratio to standard of care (begin next-line systemic therapy, best supportive care, continue current systemic line, based on treating physician decision) vs. receive stereotactic ablative radiotherapy to all oligoprogressive lesions while continuing their current systemic therapy.

Condition or disease Intervention/treatment Phase
Lung Cancer Metastatic Radiation: SABR Other: Standard of care Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized screening phase II trial
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Stereotactic Ablative Radiotherapy for Oligo-Progressive Disease REfractory to Systemic Therapy in Non Small Cell Lung Cancer: A Registry-based Phase II Randomized Trial
Actual Study Start Date : January 5, 2021
Estimated Primary Completion Date : July 1, 2023
Estimated Study Completion Date : July 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Active Comparator: Standard of care
Switch to subsequent systemic therapy line, best supportive care or continue current systemic line
Radiation: SABR
SABR to all oligoprogressive lesions + continuation of current systemic therapy

Experimental: Experimental SABR arm
Definitive SABR to oligoprogressive lesions + continue current systemic therapy
Other: Standard of care
Patients on the standard arm will be treated as per standard of care in our institution. Treatment options could include switching to next systemic therapy line, best supportive care or continuing on current systemic therapy.




Primary Outcome Measures :
  1. PFS [ Time Frame: 5 years ]
    PFS defined from randomization to disease progression at any site or death

  2. OS [ Time Frame: 5 years ]
    OS defined as time from randomization to time of death from any cause.


Secondary Outcome Measures :
  1. Quality of life Measured using the FACT-G tool, lung cancer-related patient reported outcome- CTCAE (PRO-CTCAE) [ Time Frame: 5 years ]
    Measured using the FACT-G tool, lung cancer-related patient reported outcome- CTCAE (PRO-CTCAE)

  2. Quality of life 5-level EQ-5D (EQ-5D-5L) [ Time Frame: 5 years ]
    questionnaire

  3. Grade ≥ 3 toxicity [ Time Frame: 5 years ]
    Measured using the Common Terminology Criteria for Adverse Events (CTCAE v5.0)

  4. Local control [ Time Frame: 5 years ]
    Defined as time from the end of SABR treatment to date of local failure and will be measured only in the experimental arm

  5. Time to next systemic therapy [ Time Frame: 5 years ]
    Defined as time from randomization to time of subsequent therapy line



Information from the National Library of Medicine

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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:

  • Age ≥18 years
  • Metastatic NSCLC enrolled in our CRCHUM Lung Cancer Registry and co-enrolled to the PERa registry
  • Ability to provide written informed consent
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-3
  • Oligoprogression to 1-5 extracranial lesions ≤ 5cm and involving ≤ 3 organs. Progression at the primary tumor site should be counted within the total of 5 lesions. For patients with lymph node metastases, each node is counted as one site of metastasis.
  • Oligoprogression while on ICI or TKI (any line)
  • Patients with brain metastasis are allowed; brain metastasis are not counted in the maximum number of lesions and should be treated as per standard of care
  • All sites of disease can, in the opinion of the investigator, be safely treated and targetable with SABR (taking into account prior local therapy, organ function and underlying medical condition such as inflammatory bowel disease, pulmonary fibrosis, etc.)
  • Patients with prior metastases that have been treated with ablative therapies (e.g. radiotherapy, surgery or radiofrequency ablation) before their current line of systemic therapy, are eligible.

Exclusion Criteria:

  • Any lesion beyond 5 cm
  • Pregnancy or breastfeeding
  • Any medical condition that could, in the opinion of the investigator, preclude radiotherapy or prevent follow-up after radiotherapy.
  • Presence of spinal cord compression Metastatic disease that invades the GI tract (including esophagus, stomach, small or large bowel)

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): NCT04405401


Contacts
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Contact: Silvine Benth 514-890-8254 silvine.benth.chum@ssss.gouv.qc.ca

Locations
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Canada, Quebec
Centre Hospitalier de l'Université de Montréal Recruiting
Montréal, Quebec, Canada, H2X 3E4
Contact: Diane Trudel    514-890-8254    diane.dt.trudel.chum@ssss.gouv.qc.ca   
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
AstraZeneca
Investigators
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Study Chair: Houda Bahig, MD PhD Centre hospitalier de l'Université de Montréal (CHUM)
Study Chair: Bertrand Routy, MD PhD Centre hospitalier de l'Université de Montréal (CHUM)
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Responsible Party: Houda Bahig, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT04405401    
Other Study ID Numbers: PERaLung2.0
First Posted: May 28, 2020    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Houda Bahig, Centre hospitalier de l'Université de Montréal (CHUM):
non small cell lung cancer
oligoprogression
steretactic body radiotherapy
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms