Clinical trial NCT04989725: Stereotactic Ablative Radiotherapy for Oligo-Progressive Disease REfractory to Systemic Therapy in Metastatic Cancer
Official title: Stereotactic Ablative Radiotherapy for Oligo-Progressive Disease REfractory to Systemic Therapy in Metastatic Cancer: A Phase II Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Head and Neck Cancer
Metastatic Cancer
Oligoprogressive
Keywords: head and neck cancer
metastatic cancer
oligoprogression
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2021-08-04
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized screening phase II trial
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Progression free survival
timeFrame: 5 years
Secondary outcomes:
measure: Overall survival
timeFrame: 5 years
measure: 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
timeFrame: 5 years
measure: Grade ≥ 3 toxicity Measured using the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
timeFrame: 5 years
measure: Local control
timeFrame: 5 years
measure: Time to next systemic therapy
timeFrame: 5 years
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal
state: Quebec
Study officials:
References: