Suppress-HNC: Stereotactic Ablative Radiotherapy for Oligo-Progressive Disease REfractory to Systemic Therapy in Head and Neck Cancer

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM) (Other)

Overall Status

Recruiting

CT.gov ID

NCT04989725

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer Metastatic Cancer Oligoprogressive	Other: Standard arm Radiation: Experimental arm	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

46 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized screening phase II trialRandomized 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 Head and Neck Cancer: A Phase II Randomized Trial

Actual Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Oct 1, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Progression free survival [5 years]
PFS defined from randomization to disease progression at any site or death

Secondary Outcome Measures

Overall survival [5 years]
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 [5 years]
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) [5 years]
Measured using the Common Terminology Criteria for Adverse Events
Local control [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
Time to next systemic therapy [5 years]
Defined as time from randomization to time of subsequent therapy line

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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