A Phase 2 interventional study of Stereotactic ablative radiotherapy and palliative radiotherapy in Metastatic Tumors, sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. Active, not recruiting at 10 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-05.
Sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Phase 2, Interventional, and Treatment
Stereotactic Ablative Radiotherapy (SABR) is a new radiation treatment that delivers high-dose, precise radiation to small tumors in 1-3 weeks of treatment. This new technique can potentially allow radiation treatments to be focused more precisely, and delivered more accurately than with older treatments. This improvement could help by reducing side effects and by improving the chance of controlling the cancer by more precisely treating the cancer. The purpose of this study is to compare SABR with current approaches of chemotherapy and conventional radiotherapy to assess the impact on overall survival and quality of life.
TREATMENT PLAN
6.0.1 Standard Arm (Arm 1)
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. Patients in this arm should not receive stereotactic doses or radiotherapy boosts.
Treatment recommendations are as follows:
Brain: Whole brain radiotherapy i.e. 20 Gy in 5 fractions, 30 Gy in 10 fractions
Lung: Palliative radiotherapy as per 2011 consensus guidelines.15 i.e. 8 Gy in 1 fraction, 20 Gy in 5 fractions, 30 Gy in 10 fractions
Bone: Palliative radiotherapy as per 2011 consensus guidelines.16 i.e. 8 Gy in 1 fraction (most common), 20 Gy in 5 fractions, 30 Gy in 10 fractions
Liver: 20 Gy in 5 fractions if standard institutional practice
6.0.2 Treatment Planning for Standard Arm
Treatment planning is to be done using CT simulation or conventional simulation (fluoroscopy) as per individual institutional practice. Simple beam arrangements, such as parallel opposed beams, are favored wherever possible.
6.1 Experimental Arm (Arm 2)
All treatments in this study are based on current protocols in clinical use at the LRCP and VUmc for treatment of lung,17 liver,18 brain,19,20 and spinal cord21 metastases. The guiding principle for radiotherapy is to achieve disease control but to minimize any potential adverse impact on quality of life. Concurrent chemotherapy or targeted therapy at the time of radiotherapy is not permitted within the 4 weeks prior to SABR. Hormone therapy is permitted.
6.1.1 Dose/Fractionation
Lung- tumors 3 cm or less surrounded by lung parenchyma, 54(Gy) in 3 fractions
Bone -Any bone except femur,35(Gy), in 5 fractions,daily
Brain - Non-radiosurgical,40(Gy) to metastases, in 5 fractions,daily
Adrenal, 60 (Gy), in 8 fractions, every second day
(If whole brain treated, then simultaneous boost to each lesion)
6.1.2 Immobilization
Treatment will be setup using reproducible positioning, verified using an on-line protocol, for all patients in this study. Immobilization may include a custom immobilization device, such as thermoplastic shell or vac-lok bag, as per individual institutional practice when delivering SABR. Some centers do not use immobilization devices and have demonstrated high degrees of accuracy; this is acceptable in this study.
6.1.3 Imaging/Localization/Registration All patients in Arm 2 will undergo planning CT simulation. 4-dimensional CT will be used for tumors in the lungs or liver. Axial CT images will be obtained throughout the region of interest. For centres using stereotactic radiosurgery platforms, real-time tumor tracking and orthogonal imaging systems are permitted.
Any center which is not yet experienced in lesions at any specific sub-site (e.g. adrenal metastases) shall be eligible to participate by including only patients with lesions at other pre-specified sites
It is strongly recommended that the doses to organs at risk are not to be exceeded - in some specific cases, this may require lower doses or higher fractionations than listed here. Such changes in dose will require approval of one of the local principal investigators. (see section 6.2)
3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.
This study's enrollment of 99 is above the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's is the lead sponsor of 309 studies on the registry; 126 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Controlled primary tumor
a. defined as: at least 3 months since original tumor treated definitively, with no progression at primary site
Patients with metastases that have been previously treated (e.g. prior resection, Radiofrequency Ablation (RFA) or radiotherapy):
a. If that previously treated metastasis is controlled on imaging, the patient is eligible for this study and that site does not need treatment
a. If that previously treated metastasis is NOT controlled on imaging:
Exclusion Criteria:
Standard of care, palliative radiotherapy, and chemotherapy at the discretion of the treating medical oncologist
Radiation: palliative radiotherapy
Stereotactic ablative radiotherapy, and chemotherapy at the discretion of the treating medical oncologist
Radiation: Stereotactic ablative radiotherapy
Total dose and number of fractions will depend on the site of disease. Treatment will be given daily, or every other day, over 1 -3 weeks.
Investigators should follow the principles of palliative radiotherapy as per the individual institution. Treatment recommendations are as follows: Brain: Whole brain radiotherapy i.e. 20 Gy in 5 fractions, 30 Gy in 10 fractions Lung: Palliative radiotherapy as per 2011 consensus guidelines.15 i.e. 8 Gy in 1 fraction, 20 Gy in 5 fractions, 30 Gy in 10 fractions Bone: Palliative radiotherapy as per 2011 consensus guidelines.16 i.e. 8 Gy in 1 fraction (most common), 20 Gy in 5 fractions, 30 Gy in 10 fractions Liver: 20 Gy in 5 fractions if standard institutional practice
Overall Survival
Time frame: At approximately end of year 4 (study completion)
Quality of life: Assessed with the Functional Assessment of Cancer Therapy: General (FACT-G)
Time frame: At approximately end of year 2, and end of year 4 (study completion)
Toxicity: Assessed by the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4 for each organ treated (e.g. liver, lung, bone)
Time frame: At approximately the end of years 1, 2, 3, and 4 (study completion)
Progression-free survival
Time frame: At approximately end of year 2, and end of year 4 (study completion)
Lesional control rate
Time frame: At approximately end of year 2, and end of year 4 (study completion)
Number of cycles of further chemotherapy/systemic therapy
Time frame: At approximately end of year 2, and end of year 4 (study completion)
This study is active, not recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's