Stereotactic Ablative Radiotherapy for Oligo-Progressive Disease REfractory to Systemic Therapy in Metastatic Cancer
NCT ID: NCT04989725
Last Updated: 2023-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
46 participants
INTERVENTIONAL
2021-10-01
2027-12-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Standard of care
Switch to subsequent systemic therapy line, best supportive care or continue current systemic line
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 SABR arm
Definitive SABR to oligoprogressive lesions + continue current systemic therapy
Experimental arm
SABR to all oligoprogressive lesions + continuation of current systemic therapy
Interventions
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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 arm
SABR to all oligoprogressive lesions + continuation of current systemic therapy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Centre hospitalier de l'Université de Montréal (CHUM)
OTHER
Responsible Party
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Locations
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Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Silvine Benth
Role: primary
Other Identifiers
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Suppress
Identifier Type: -
Identifier Source: org_study_id