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NCT Number: NCT04989725

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 3E4, Canada

Location status: Recruiting

Location contact

Denis Soulières, MD

SUB_INVESTIGATOR

Houda Bahig, MD, PhD

PRINCIPAL_INVESTIGATOR

Silvine Benth

CONTACT

[email protected]

514-890-8254

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Experimental Arm

Radiation

SABR to all oligoprogressive lesions + continuation of current systemic therapy

Primary outcomes

  1. Progression free survival

    Time frame: 5 years

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

Secondary outcomes

  1. Overall survival

    Time frame: 5 years

    OS defined as time from randomization to time of death from any cause.

  2. Quality of life Measured using the FACT-G tool, patient reported outcome- CTCAE (PRO-CTCAE) and Quality of life 5-level EQ-5D

    Time frame: 5 years

    Measured using the FACT-G tool, patient reported outcome- CTCAE (PRO-CTCAE) and quality of life 5-level EQ-5D

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

    Time frame: 5 years

    Measured using the Common Terminology Criteria for Adverse Events

  4. Local control

    Time frame: 5 years

    Defined as time from the end of SABR treatment to date of local failure and will be measured only in the experimental arm

  5. Time to next systemic therapy

    Time frame: 5 years

    Defined as time from randomization to time of subsequent therapy line

Study contacts

Contact information is provided by the study sponsor or research team.

Mom Phat

CONTACT

[email protected]

514-890-8254

Silvine Benth

CONTACT

[email protected]

514-890-8254

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Official study title

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

Acronym: SUPPRESS

Important dates

Study start
2021
Primary completion
2027
Study completion
2029
First posted
Aug 4, 2021
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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