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

NCT05717166 | Recruiting Phase 3 DMC

• 1 other identifier: ReDA 13176
• Study Type: interventional
• Target: 180
• Locations: 2 countries
• Sites: 5

Brief Summary

This study is a phase III multi-institutional randomized trial. Patients will be randomized in a 1:2 ratio between current standard of care treatment (Arm 1) vs. standard of care treatment + SABR (Arm 2) to sites of known disease. Patients will be stratified by two of the strongest prognostic factors, based on a large multi-institutional analysis3: histology (Group 1: hormone-sensitive prostate cancer, breast, or renal; Group 2: all others), and number of metastases (Group 1: 1-3; Group 2: 4-10).

Conditions

Metastatic Tumor

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Time from randomization to death from any cause, or date of last follow-up, whichever occurs first.

  Approximately end of year 6 (Study Completion)

Secondary Outcomes (5)

• Quality of Life (QOL) assessed with the Functional Assessment of Cancer Therapy: General (FACT-G).

  Quality of Life outcomes to be collected for the first 2 years (3, 6, 12, 18, 24 months)

• Quality of Life (QOL) assessed with the Functional Assessment of Cancer Therapy: The EuroQol 5-Dimension 5-Level (EQ-5D-5L).

  Quality of Life outcomes to be collected for the first 2 years (3, 6, 12, 18, 24 months)

• Toxicity assessed by the Common Toxicity Criteria for Adverse Events (CTCAE) version 5 for each organ treated (e.g. liver, lung, bone).

  Toxicity outcomes to be collected for the first 2 years (Last week of treatment, in 6 weeks, in 3, 6, 12, 18, 24 months)

• Time to next systemic therapy

  From randomization to year 6 (study completion).

• Receipt of additional radiation during follow-up

  During year 6 (follow-up year).

Study Arms (2)

Standard Arm (Arm 1)

ACTIVE COMPARATOR

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.

Radiation: Palliative Radiotherapy; Drug: Chemotherapy; Drug: Hormone therapy; Drug: Immunotherapy; Drug: Targeted Systemic Therapy; Other: Observation

Experimental Arm (Arm 2)

EXPERIMENTAL

Consists of treatment to the primary tumor and metastases, with SABR preferred, but other options all allowable (e.g. surgery, RFA, fractionated radiation, chemoradiation) if those are deemed to be preferable by the treating oncologists.

Radiation: Palliative Radiotherapy; Drug: Chemotherapy; Drug: Hormone therapy; Drug: Immunotherapy; Drug: Targeted Systemic Therapy; Other: Observation; Radiation: Stereotactic Ablative Radiotherapy; Procedure: Surgery; Other: Radiofrequency Therapy (RFA); Radiation: Fractionated Radiation

Interventions

Palliative Radiotherapy RADIATION

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.

Experimental Arm (Arm 2); Standard Arm (Arm 1)

Chemotherapy DRUG

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

Also known as: Cytotoxic Systemic Therapy

Experimental Arm (Arm 2); Standard Arm (Arm 1)

Hormone therapy DRUG

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

Also known as: Hormonal Systemic Therapy

Experimental Arm (Arm 2); Standard Arm (Arm 1)

Immunotherapy DRUG

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

Experimental Arm (Arm 2); Standard Arm (Arm 1)

Targeted Systemic Therapy DRUG

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

Experimental Arm (Arm 2); Standard Arm (Arm 1)

Observation OTHER

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

Experimental Arm (Arm 2); Standard Arm (Arm 1)

Surgery PROCEDURE

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.

Experimental Arm (Arm 2)

Radiofrequency Therapy (RFA) OTHER

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.

Experimental Arm (Arm 2)

Fractionated Radiation 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.

Experimental Arm (Arm 2)

Stereotactic Ablative Radiotherapy RADIATION

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).

Experimental Arm (Arm 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Willing to provide informed consent
• Karnofsky performance status \> 60
• Life expectancy \> 6 months
• Histologically confirmed malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required.
• Total number of metastases 1-10 at the time of enrollment, with a primary tumor also present
• Restaging completed within 12 weeks prior to randomization (see section 5.1)
• For patients receiving thoracic radiotherapy, the enrolling physician must confirm there are no computed tomography (CT) changes suggestive of fibrotic interstitial lung disease (ILD) (i.e. reticular changes, traction bronchiectasis, or honeycombing) reported on any prior CT scans. If any are present, the patient must be assessed by a respirologist to rule out ILD prior to enrollment.
• or fewer lifetime metastases from the cancer for which participants are being enrolled

You may not qualify if:

• Serious medical comorbidities precluding radiotherapy. These include ILD in patients requiring thoracic radiation, Crohn's disease in patients where the gastrointestinal (GI) tract will receive radiotherapy, or ulcerative colitis where the bowel will receive radiotherapy and connective tissue disorders such as lupus or scleroderma.
• For patients with liver metastases, moderate/severe liver dysfunction (Child Pugh B or C); please see the Child-Pugh score calculator.
• Substantial overlap with a previously treated radiation volume. Prior radiotherapy in general is allowed, as long as the composite plan meets dose constraints herein. For patients treated with radiation previously, biological effective dose calculations should be used to equate previous doses to the tolerance doses listed in Appendix 1. All such cases must be discussed with a member of the study steering committee.
• Malignant pleural effusion
• Inability to treat all sites of disease
• Brain metastasis \> 3 cm in size or a total volume of brain metastases greater than 30 cc.
• Metastasis in the brainstem
• Clinical or radiologic evidence of spinal cord compression
• Metastatic disease that invades any of the following: GI tract (including esophagus, stomach, small or large bowel), or skin
• Pregnant or lactating women

Sponsors & Collaborators

• David Palma: lead

Study Sites (5)

BC Cancer - Centre for the North

Prince George, British Columbia, V2M 7E9, Canada

NOT YET RECRUITING

BC Cancer - Vancouver

Vancouver, British Columbia, V5Z 4C2, Canada

RECRUITING

London Regional Cancer Program of the Lawson Health Research Institute

London, Ontario, N6A 5W9, Canada

RECRUITING

Centre Hospitalier de l'Université de Montréal-CHUM

Montreal, Quebec, H2X 0C1, Canada

RECRUITING

Universitätsspital Zürich

Zurich, Switzerland

RECRUITING

Related Publications (1)

• Palma DA, Giuliani ME, Correa RJM, Schneiders FL, Harrow S, Guckenberger M, Zhang T, Bahig H, Senthi S, Chung P, Olson R, Lock M, Raman S, Bauman GS, Lok BH, Laba JM, Glicksman RM, Nguyen TK, Lang P, Helou J, Goodman CD, Mendez LC, van Rossum PSN, Warner A, Gaede S, Allan AL. A randomized phase III trial of stereotactic ablative radiotherapy for patients with up to 10 oligometastases and a synchronous primary tumor (SABR-SYNC): study protocol. BMC Palliat Care. 2024 Sep 7;23(1):223. doi: 10.1186/s12904-024-01548-7.

  PMID: 39244532 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Drug Therapy; Immunotherapy; Observation; Surgical Procedures, Operative; Radiofrequency Therapy

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Immunomodulation; Biological Therapy; Methods; Investigative Techniques

Central Study Contacts

David Palma, MD, PhD

CONTACT

519-685-8650; David.Palma@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: February 8, 2023
• Study Start: October 6, 2023
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4); CH (1)