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

Head and Neck Cancer Clinical Trial

— SUPPRESS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04989725
• Other study ID #: Suppress
• Status: Recruiting
• Phase: Phase 2
• Start date: October 1, 2021
• Est. completion date: December 1, 2027

Study information

• Verified date: December 2023
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: Silvine Benth
• Phone: 514-890-8254
• Email: silvine.benth.chum[@]ssss.gouv.qc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: December 1, 2027
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease Progression
• Head and Neck Cancer
• Head and Neck Neoplasms
• Metastatic Cancer
• Neoplasm Metastasis
• Neoplasms
• Neoplasms, Second Primary
• Oligoprogressive

Intervention

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.

Radiation:
• Experimental arm
SABR to all oligoprogressive lesions + continuation of current systemic therapy

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'Université de Montréal	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival	PFS defined from randomization to disease progression at any site or death	5 years
Secondary	Overall survival	OS defined as time from randomization to time of death from any cause.	5 years
Secondary	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
Secondary	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
Secondary	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
Secondary	Time to next systemic therapy	Defined as time from randomization to time of subsequent therapy line	5 years