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

NCT04989725 | Recruiting Phase 2 DMC

• 1 other identifier: Suppress
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer; Metastatic Cancer; Oligoprogressive

Keywords

head and neck cancer; metastatic cancer; oligoprogression

Outcome Measures

Primary Outcomes (1)

• Progression free survival

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

  5 years

Secondary Outcomes (5)

• Overall survival

  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

  5 years

• Grade ≥ 3 toxicity Measured using the Common Terminology Criteria for Adverse Events (CTCAE v5.0)

  5 years

• Local control

  5 years

• Time to next systemic therapy

  5 years

Study Arms (2)

Standard of care

ACTIVE COMPARATOR

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

Other: Standard arm

Experimental SABR arm

EXPERIMENTAL

Definitive SABR to oligoprogressive lesions + continue current systemic therapy

Radiation: Experimental arm

Interventions

Standard arm OTHER

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.

Standard of care

Experimental arm RADIATION

SABR to all oligoprogressive lesions + continuation of current systemic therapy

Experimental SABR arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 3E4, Canada

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Silvine Benth

CONTACT

514-890-8254; silvine.benth.chum@ssss.gouv.qc.ca

Mom Phat

CONTACT

514-890-8254; mom.phat.chum@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized screening phase II trial

Study Record Dates

• First Submitted: July 30, 2021
• First Posted: August 4, 2021
• Study Start: October 1, 2021
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 12, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)