| Titre |
A Randomized Phase III Trial of Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of 4-10 Oligometastatic Tumors |
| Protocole ID |
SABR-COMET 10 |
| ClinicalTrials.gov ID |
NCT03721341 |
| Type(s) de cancer |
Tumeurs solides |
| Phase |
Phase III |
| Stade |
Métastatique |
| Type étude |
Traitement |
| Médicament |
Radiothérapie ablative |
| Institution |
CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dre Houda Bahig
|
| Coordonnateur(trice) |
Diane Trudel
514-890-8000 poste 11181
|
| Statut |
 Actif en recrutement |
| Critètes d'éligibilité |
- Age 18 or older
- Willing to provide informed consent
- Karnofsky performance score greater than 60
- Life expectancy greater than 6 months
- Histologically confirmed malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required.
- Controlled primary tumor defined as: at least 3 months since original tumor treated definitively, with no progression at primary site
- Total number of metastases 4-10
- All sites of disease can be safely treated based on a pre-plan
|
| Critètes d'exclusion |
- Serious medical comorbidities precluding radiotherapy. These include interstitial lung disease in patients requiring thoracic radiation, Crohn's disease in patients where the GI tract 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)
- 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 below. All such cases must be discussed with one of the study PIs.
- Malignant pleural effusion
- Inability to treat all sites of disease
- Any single metastasis greater than 5 cm in size.
- Any brain metastasis greater than 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
- Dominant brain metastasis requiring surgical decompression
- Metastatic disease that invades any of the following: GI tract (including esophagus, stomach, small or large bowel), mesenteric lymph nodes, or skin
- Pregnant or lactating women
|
Groupe d'étude en oncologie du Québec