Titre A Pilot Study of Two Dose Escalation Strategies to Increase the Population of Complete Responders After Radiation Therapy in Rectal Cancer Patients.
Protocole ID Morpheus study (no surgery)
ClinicalTrials.gov ID NCT03051464
Type(s) de cancer Côlon et rectum
Phase
Type étude Clinique
Institution CISSS DE L'OUTAOUAIS
   HOPITAL DE GATINEAU
      909 Boulevard La Vérendrye, Gatineau, QC, J8P 7H2
Ville Gatineau
Investigateur(trice) principal(e) Dr Robert Archambault
Coordonnateur(trice) Céline Roy
 819-966-6100 poste 3669
Statut Actif en recrutement
Critètes d'éligibilité
  • Rectal cancer patients, clinically staged as T2-T3 by MRI or endoscopic/trans-rectal ultrasound
  • Rectal cancer staged as N0-N1 by MRI or EUS/TRUS
  • No metastatic lesion
  • Rectal tumor occupying less than half of the circumference
  • Tumor less than 5 cm on its largest dimension
  • Tumor located at less than 10 cm from the anal verge
  • Tumor penetration less than 5 mm in the mesorectal fat
  • Tumor accessible for brachytherapy
  • Lumen accessible for colonoscopy
  • Patient should be a suitable candidate for brachytherapy and chemotherapy
  • Older than 18 years of age
  • Adequate birth control measures in women of childbearing potential
  • Written informed consent
Critètes d'exclusion
  • Patients with previous pelvic radiation
  • Evidence of distant metastasis
  • Extension of malignant disease to the anal canal
  • Tumors staged as T4
  • Tumors larger than 5 cm in length