| Titre |
A Phase III Trial of Stereotactic Radiosurgery Compared With Whole Brain Radiotherapy (WBRT) for 5-15 Brain Metastases |
| Protocole ID |
CE.7 |
| ClinicalTrials.gov ID |
NCT03550391 |
| Type(s) de cancer |
Cerveau (SNC) |
| Phase |
Phase III |
| Type étude |
Traitement |
| Institution |
CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dr David Roberge
|
| Coordonnateur(trice) |
Mom Phat
514-890-8000 poste 11171
|
| Statut |
 Actif en recrutement |
| Date d'activation |
24-09-2018 |
| Critètes d'éligibilité |
- Patients must have 5 or more brain metastases as counted on a T1 contrast enhanced MRI obtained ≤ 30 days from randomization (maximum 15 brain metastases).
- Patients must have a pathological diagnosis (cytological or histological) of a non-hematopoietic malignancy.
- The largest brain metastasis must measure <2.5 cm in maximal diameter.
- Centre must have the ability to treat patients with either a Gamma Knife, Cyberknife, or a linear accelerator-based radiosurgery system.
- Patient must be > 18 years of age.
- Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires in either English or French either alone or with assistance.
- ECOG performance status 0, 1, or 2.
- Creatinine clearance must be ≥ 30 ml/min within 28 days prior to registration.
- The Neurocognitive Testing examiner must have credentialing confirming completion of the neurocognitive testing training.
- Facility is credentialed by IROC to perform SRS. The treating centre must have completed stereotactic radiosurgery credentialing of the specific system(s) to be used in study patients.
- Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrolment in the trial to document their willingness to participate.
- A similar process must be followed for sites outside of Canada as per their respective cooperative group's procedures.
- Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
- In accordance with CCTG policy, protocol treatment is to begin within 14 days of patient enrolment.
- Women/men of childbearing potential must have agreed to use a highly effective contraceptive method.
|
| Critètes d'exclusion |
- Pregnant or nursing women.
- Men or women of childbearing potential who are unwilling to employ adequate contraception.
- Inability to complete a brain MRI.
- Known allergy to gadolinium.
- Prior cranial radiation therapy.
- Planned cytotoxic chemotherapy within 48 hours prior or after the SRS or WBRT.
- Primary germ cell tumour, small cell carcinoma, or lymphoma.
- Widespread definitive leptomeningeal metastasis. This includes cranial nerve palsy, leptomeningeal carcinomatosis, ependymal involvement, cranial nerve involvement on imaging, suspicious linear meningeal enhancement, or cerebrospinal fluid (CSF) positive for tumour cells.
- A brain metastasis that is located ≤ 5 mm of the optic chiasm or either optic nerve.
- Surgical resection of a brain metastasis (stereotactic biopsies will be allowed).
- More than 15 brain metastases on a volumetric T1 contrast MRI (voxels of 1mm or smaller) performed within the past 14 days, or more than 10 metastases in the case of a non-volumetric MRI.
- Prior allergic reaction to memantine.
- Current alcohol or drug abuse.
- Current use of NMDA antagonists, such as amantadine, ketamine, or dextromethorphan.
- Diagnosis of chronic liver disease/cirrhosis of the liver (e.g. Child-Pugh class B or C).
|
Groupe d'étude en oncologie du Québec