Recruiting
Phase 2

Stereotactic Ablative Radiotherapy

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT04989725

Conditions

Metastatic Cancer

Oligoprogressive

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Standard arm

Experimental arm

Study Details

Brief summary:

A registry-based randomized phase II trial. A total of 46 patients with metastatic 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

Metastatic Cancer

Oligoprogressive

Study ID

NCT04989725

Start date

Oct 1, 2021

Status verified date

Jul, 2026

Completion date

Mar 1, 2029

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥18 years
  • Metastatic cancer (any histology), 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

Study Design

Enrollment

46 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard of care

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

experimental: Experimental SABR arm

Definitive SABR to oligoprogressive lesions + continue current systemic therapy

Interventions

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

Primary outcome measure

  • Progression free survival [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Silvine Benth

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

Mom Phat

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

Locations

Centre Hospitalier de l'Université de Montréal

Recruiting

Montreal, Quebec, Canada, H2X 3E4

Contacts

Silvine Benth

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

Principal Investigator:

Houda Bahig, MD, PhD

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Keywords

  • metastatic cancer
  • oligoprogression

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2026-07-22.