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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre hospitalier de l'Université de Montréal (CHUM)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard arm

    Other intervention

    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

Treatment groups

46 Participants
are divided into 2 treatment groups
Group A: Standard of careActive comparator 1 intervention
Group B: Experimental SABR armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression free survival

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

Time frame
5 years

Secondary outcomes

1

Overall survival

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

Time frame
5 years
2

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

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

Time frame
5 years
3

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

Measured using the Common Terminology Criteria for Adverse Events

Time frame
5 years
4

Local control

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

Time frame
5 years

Other outcomes

Sponsors and contacts

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