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Stereotactic Ablative Radiotherapy for Oligo-Progressive Disease REfractory to Systemic Therapy in Metastatic Cancer (SUPPRESS)

Primary Purpose

Head and Neck Cancer, Metastatic Cancer, Oligoprogressive

Status
Recruiting
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Standard arm
Experimental arm
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring head and neck cancer, metastatic cancer, oligoprogression

Eligibility Criteria

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

Inclusion Criteria:

  • Age ≥18 years
  • Biopsy proven HNSCC (oropharynx, oral cavity, nasopharynx, sinonasal, larynx or hypopharynx)
  • Metastatic HNSCC, with pathological or radiological proof of metastasis
  • Ability to provide written informed consent
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Progressive disease while on systemic treatment (any line), defined as per RECIST criteria 1.1 on CT metrics as a greater than 20% increase in the sum measurement of lesions, non-target unequivocal progressive disease or a new lesion on CT.
  • 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.
  • 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:

  • 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

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

Secondary Outcome Measures

Overall survival
OS defined as time from randomization to time of death from any cause.
Quality of life Measured using the FACT-G tool, head and neck cancer-related patient reported outcome- CTCAE (PRO-CTCAE) and Quality of life 5-level EQ-5D
Measured using the FACT-G tool, lung cancer-related patient reported outcome- CTCAE (PRO-CTCAE) and quality of life 5-level EQ-5D
Grade ≥ 3 toxicity Measured using the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
Measured using the Common Terminology Criteria for Adverse Events
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

First Posted
July 30, 2021
Last Updated
November 11, 2022
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
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1. Study Identification

Unique Protocol Identification Number
NCT04989725
Brief Title
Stereotactic Ablative Radiotherapy for Oligo-Progressive Disease REfractory to Systemic Therapy in Metastatic Cancer
Acronym
SUPPRESS
Official Title
Stereotactic Ablative Radiotherapy for Oligo-Progressive Disease REfractory to Systemic Therapy in Metastatic Cancer: A Phase II Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
October 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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A registry-based randomized phase II trial. A total of 46 patients with metastatic head and neck 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
Head and Neck Cancer, Metastatic Cancer, Oligoprogressive
Keywords
head and neck cancer, metastatic cancer, oligoprogression

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
46 (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
Other
Intervention Name(s)
Standard arm
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.
Intervention Type
Radiation
Intervention Name(s)
Experimental arm
Intervention Description
SABR to all oligoprogressive lesions + continuation of current systemic therapy
Primary Outcome Measure Information:
Title
Progression free survival
Description
PFS defined from randomization to disease progression at any site or death
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Overall survival
Description
OS defined as time from randomization to time of death from any cause.
Time Frame
5 years
Title
Quality of life Measured using the FACT-G tool, head and neck cancer-related patient reported outcome- CTCAE (PRO-CTCAE) and Quality of life 5-level EQ-5D
Description
Measured using the FACT-G tool, lung cancer-related patient reported outcome- CTCAE (PRO-CTCAE) and quality of life 5-level EQ-5D
Time Frame
5 years
Title
Grade ≥ 3 toxicity Measured using the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
Description
Measured using the Common Terminology Criteria for Adverse Events
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
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 years Biopsy proven HNSCC (oropharynx, oral cavity, nasopharynx, sinonasal, larynx or hypopharynx) Metastatic HNSCC, with pathological or radiological proof of metastasis Ability to provide written informed consent Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Progressive disease while on systemic treatment (any line), defined as per RECIST criteria 1.1 on CT metrics as a greater than 20% increase in the sum measurement of lesions, non-target unequivocal progressive disease or a new lesion on CT. 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. 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: 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
Email
silvine.benth.chum@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Mom Phat
Phone
514-890-8254
Email
mom.phat.chum@ssss.gouv.qc.ca
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
Silvine Benth
Phone
514-890-8254
Email
silvine.benth.chum@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name & Degree
Houda Bahig, MD, PhD
First Name & Middle Initial & Last Name & Degree
Denis Soulières, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Stereotactic Ablative Radiotherapy for Oligo-Progressive Disease REfractory to Systemic Therapy in Metastatic Cancer

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