Trial Title:
A Randomized Phase III Trial of Stereotactic Ablative Radiotherapy for Patients With Up to 10 Oligometastases and a Synchronous Primary Tumor.
NCT ID:
NCT05717166
Condition:
Metastatic Tumor
Conditions: Official terms:
Neoplasm Metastasis
Hormones
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Palliative Radiotherapy
Description:
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.
Arm group label:
Experimental Arm (Arm 2)
Arm group label:
Standard Arm (Arm 1)
Intervention type:
Drug
Intervention name:
Chemotherapy
Description:
Pre-specified based on the standard of care approach for that patient.
Arm group label:
Experimental Arm (Arm 2)
Arm group label:
Standard Arm (Arm 1)
Other name:
Cytotoxic Systemic Therapy
Intervention type:
Drug
Intervention name:
Hormone therapy
Description:
Pre-specified based on the standard of care approach for that patient.
Arm group label:
Experimental Arm (Arm 2)
Arm group label:
Standard Arm (Arm 1)
Other name:
Hormonal Systemic Therapy
Intervention type:
Drug
Intervention name:
Immunotherapy
Description:
Pre-specified based on the standard of care approach for that patient.
Arm group label:
Experimental Arm (Arm 2)
Arm group label:
Standard Arm (Arm 1)
Intervention type:
Drug
Intervention name:
Targeted Systemic Therapy
Description:
Pre-specified based on the standard of care approach for that patient.
Arm group label:
Experimental Arm (Arm 2)
Arm group label:
Standard Arm (Arm 1)
Intervention type:
Other
Intervention name:
Observation
Description:
Pre-specified based on the standard of care approach for that patient.
Arm group label:
Experimental Arm (Arm 2)
Arm group label:
Standard Arm (Arm 1)
Intervention type:
Radiation
Intervention name:
Stereotactic Ablative Radiotherapy
Description:
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).
Arm group label:
Experimental Arm (Arm 2)
Intervention type:
Procedure
Intervention name:
Surgery
Description:
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.
Arm group label:
Experimental Arm (Arm 2)
Intervention type:
Other
Intervention name:
Radiofrequency Therapy (RFA)
Description:
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.
Arm group label:
Experimental Arm (Arm 2)
Intervention type:
Radiation
Intervention name:
Fractionated Radiation
Description:
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.
Arm group label:
Experimental Arm (Arm 2)
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).
Criteria for eligibility:
Criteria:
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.
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
BC Cancer - Centre for the North
Address:
City:
Prince George
Zip:
V2M 7E9
Country:
Canada
Status:
Not yet recruiting
Investigator:
Last name:
Robert Olson, MD, MSc
Email:
Principal Investigator
Facility:
Name:
London Regional Cancer Program of the Lawson Health Research Institute
Address:
City:
London
Zip:
N6A 5W9
Country:
Canada
Status:
Recruiting
Contact:
Last name:
David Palma, MD, PhD
Phone:
519-685-8650
Email:
David.Palma@lhsc.on.ca
Investigator:
Last name:
David Palma, MD, PhD
Email:
Principal Investigator
Facility:
Name:
Centre Hospitalier de l'Université de Montréal-CHUM
Address:
City:
Montréal
Zip:
H2X 0C1
Country:
Canada
Status:
Not yet recruiting
Investigator:
Last name:
Houda Bahig, MD, PhD
Email:
Principal Investigator
Start date:
October 6, 2023
Completion date:
April 2029
Lead sponsor:
Agency:
David Palma
Agency class:
Other
Source:
Lawson Health Research Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05717166
