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

Primary Purpose

Lung Cancer Metastatic

Status

Recruiting

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

SABR

Standard of care

About this trial

This is an interventional treatment trial for Lung Cancer Metastatic focused on measuring non small cell lung cancer, oligoprogression, steretactic body radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Centre Hospitalier de l'Université de MontréalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of care

Experimental SABR arm

Arm Description

Switch to subsequent systemic therapy line, best supportive care or continue current systemic line

Definitive SABR to oligoprogressive lesions + continue current systemic therapy

Outcomes

Primary Outcome Measures

PFS

PFS defined from randomization to disease progression at any site or death

OS defined as time from randomization to time of death from any cause.

Secondary Outcome Measures

Quality of life Measured using the FACT-G tool, lung cancer-related patient reported outcome- CTCAE (PRO-CTCAE)

Measured using the FACT-G tool, lung cancer-related patient reported outcome- CTCAE (PRO-CTCAE)

Quality of life 5-level EQ-5D (EQ-5D-5L)

questionnaire

Grade ≥ 3 toxicity

Measured using the Common Terminology Criteria for Adverse Events (CTCAE v5.0)

Local control

Defined as time from the end of SABR treatment to date of local failure and will be measured only in the experimental arm

Time to next systemic therapy

Defined as time from randomization to time of subsequent therapy line

Full Information

NCT ID

NCT04405401

First Posted

May 24, 2020

Last Updated

April 24, 2023

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

1. Study Identification

Unique Protocol Identification Number

NCT04405401

Brief Title

Stereotactic Ablative Radiotherapy for Oligo-Progressive Non Small Cell Lung Cancer

Acronym

SUPPRESS-NSCLC

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 5, 2021 (Actual)

Primary Completion Date

July 1, 2023 (Anticipated)

Study Completion Date

July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer Metastatic

Keywords

non small cell lung cancer, oligoprogression, steretactic body radiotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Randomized screening phase II trial

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard of care

Arm Type

Active Comparator

Arm Description

Switch to subsequent systemic therapy line, best supportive care or continue current systemic line

Arm Title

Experimental SABR arm

Arm Type

Experimental

Arm Description

Definitive SABR to oligoprogressive lesions + continue current systemic therapy

Intervention Type

Radiation

Intervention Name(s)

SABR

Intervention Description

SABR to all oligoprogressive lesions + continuation of current systemic therapy

Intervention Type

Other

Intervention Name(s)

Standard of care

Intervention Description

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 Measure Information:

Title

PFS

Description

PFS defined from randomization to disease progression at any site or death

Time Frame

5 years

Title

Description

OS defined as time from randomization to time of death from any cause.

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Quality of life Measured using the FACT-G tool, lung cancer-related patient reported outcome- CTCAE (PRO-CTCAE)

Description

Measured using the FACT-G tool, lung cancer-related patient reported outcome- CTCAE (PRO-CTCAE)

Time Frame

5 years

Title

Quality of life 5-level EQ-5D (EQ-5D-5L)

Description

questionnaire

Time Frame

5 years

Title

Grade ≥ 3 toxicity

Description

Measured using the Common Terminology Criteria for Adverse Events (CTCAE v5.0)

Time Frame

5 years

Title

Local control

Description

Defined as time from the end of SABR treatment to date of local failure and will be measured only in the experimental arm

Time Frame

5 years

Title

Time to next systemic therapy

Description

Defined as time from randomization to time of subsequent therapy line

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Silvine Benth

Phone

514-890-8254

silvine.benth.chum@ssss.gouv.qc.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Houda Bahig, MD PhD

Organizational Affiliation

Centre hospitalier de l'Université de Montréal (CHUM)

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Bertrand Routy, MD PhD

Organizational Affiliation

Centre hospitalier de l'Université de Montréal (CHUM)

Official's Role

Study Chair

Facility Information:

Facility Name

Centre Hospitalier de l'Université de Montréal

City

Montréal

State/Province

Quebec

ZIP/Postal Code

H2X 3E4

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Diane Trudel

Phone

514-890-8254

diane.dt.trudel.chum@ssss.gouv.qc.ca

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Stereotactic Ablative Radiotherapy for Oligo-Progressive Non Small Cell Lung Cancer

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