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

Stereotactic Ablative Radiotherapy for Oligo-Progressive Disease REfractory to Systemic Therapy in Metastatic Cancer: A Phase II Randomized Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer; Oligoprogressive; Metastatic Cancer
• Intervention / Treatment: Other: Standard arm; Radiation: Experimental arm

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Silvine Benth; Phone Number: 514-890-8254; Email: silvine.benth.chum@ssss.gouv.qc.ca
• Study Contact Backup: Name: Mom Phat; Phone Number: 514-890-8254; Email: mom.phat.chum@ssss.gouv.qc.ca

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H2X 3E4
      • Recruiting
      • Centre Hospitalier de l'Universite de Montreal
      • Contact: Silvine Benth; Phone Number: 514-890-8254; Email: silvine.benth.chum@ssss.gouv.qc.ca
      • Principal Investigator: Houda Bahig, MD, PhD
      • Sub-Investigator: Denis Soulières, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of care; Switch to subsequent systemic therapy line, best supportive care or continue current systemic line	Other: Standard arm; 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.
Experimental: Experimental SABR arm; Definitive SABR to oligoprogressive lesions + continue current systemic therapy	Radiation: Experimental arm; SABR to all oligoprogressive lesions + continuation of current systemic therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival	PFS defined from randomization to disease progression at any site or death	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	5 years
Time to next systemic therapy	Defined as time from randomization to time of subsequent therapy line	5 years
Overall survival	OS defined as time from randomization to time of death from any cause.	5 years
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	5 years
Grade ≥ 3 toxicity Measured using the Common Terminology Criteria for Adverse Events (CTCAE v5.0)	Measured using the Common Terminology Criteria for Adverse Events	5 years

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: July 30, 2021
• First Submitted That Met QC Criteria: July 30, 2021
• First Posted (Actual): August 4, 2021

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: metastatic cancer; head and neck cancer; oligoprogression
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Disease Attributes; Neoplastic Processes; Neoplasms; Disease Progression; Head and Neck Neoplasms; Neoplasm Metastasis; Neoplasms, Second Primary
• Other Study ID Numbers: Suppress

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No