A Randomized Phase III Trial of Stereotactic Ablative Radiotherapy for Patients With Up to 10 Oligometastases and a Synchronous Primary Tumor.

PHASE3RecruitingINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

October 6, 2023

Primary Completion Date

April 30, 2029

Study Completion Date

April 30, 2029

Conditions
Metastatic Tumor
Interventions
RADIATION

Palliative Radiotherapy

Radiotherapy for patients in the standard arm should follow the principles of palliative radiotherapy as per the individual institution, with the goal of alleviating symptoms or preventing imminent complications. Recommended dose fractionations in this arm will include 8 Gy in 1 fraction, 20 Gy in 5 fractions, and 30 Gy in 10 fractions.

DRUG

Chemotherapy

Pre-specified based on the standard of care approach for that patient.

DRUG

Hormone therapy

Pre-specified based on the standard of care approach for that patient.

DRUG

Immunotherapy

Pre-specified based on the standard of care approach for that patient.

DRUG

Targeted Systemic Therapy

Pre-specified based on the standard of care approach for that patient.

OTHER

Observation

Pre-specified based on the standard of care approach for that patient.

RADIATION

Stereotactic Ablative Radiotherapy

"The primary tumor may be treated with SABR or with other local modalities at the discretion of the treating team and/or the local multidisciplinary tumor board.~Preferred doses are 20 Gy in 1 fraction, 30 Gy in 3 fractions (every second day), and 35 Gy in 5 fractions (daily)."

PROCEDURE

Surgery

"Treatment to the primary tumor and metastases, with SABR preferred, but other options all allowable if those are deemed to be preferable by the treating oncologists.~The primary tumor may be treated with SABR or with other local modalities at the discretion of the treating team and/or the local multidisciplinary tumor board. Because of the convenience in using SABR for all lesions, non-SABR modalities should only be used if they are likely to provide a benefit over SABR."

OTHER

Radiofrequency Therapy (RFA)

Treatment to the primary tumor and metastases, with SABR preferred, but other options all allowable if those are deemed to be preferable by the treating oncologists.

RADIATION

Fractionated Radiation

"Treatment to the primary tumor and metastases, with SABR preferred, but other options all allowable if those are deemed to be preferable by the treating oncologists.~Tumors in the esophagus, stomach, small intestine or colon should be treated with either fractionated radiation or a lower SABR dose (e.g. 25 Gy in 5 fractions) to minimize the risk of perforation."

Trial Locations (4)

V2M 7E9

NOT_YET_RECRUITING

BC Cancer - Centre for the North, Prince George

V5Z 4C2

RECRUITING

BC Cancer - Vancouver, Vancouver

N6A 5W9

RECRUITING

London Regional Cancer Program of the Lawson Health Research Institute, London

H2X 0C1

RECRUITING

Centre Hospitalier de l'Université de Montréal-CHUM, Montreal

All Listed Sponsors
lead

David Palma

OTHER