Recruiting

Phase 3

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

Sponsor:

David Palma

Code:

NCT05717166

Conditions

Metastatic Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Palliative Radiotherapy

Chemotherapy

Hormone therapy

Immunotherapy

Targeted Systemic Therapy

Study Details

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

Study ID

NCT05717166

Start date

Oct 6, 2023

Status verified date

Dec, 2025

Completion date

Apr, 2029

Anticipated

Primary completion date

Apr, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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.
10 or fewer lifetime metastases from the cancer for which participants are being enrolled

Exclusion Criteria:

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

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard Arm (Arm 1)

experimental: Experimental Arm (Arm 2)

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.

Interventions

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.

Chemotherapy