Title 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
Cancer Type(s) Colon and Rectum
Phase
Stage
Study Type Clinical
Drug
Institution CIUSSS DU CENTRE-OUEST-DE-L'ILE-DE-MONTREAL
   HOPITAL GENERAL JUIF SIR MORTIMER B.DAVIS
      3755 rue de la Côte Ste. Catherine, Montréal, QC, H3T 1E2
City Montréal
Principal Investigator Dr. Té Vuong
Coordinator Emma Starr
514-340-8222 poste 28443
Status Recruiting
Activation Date
Eligibility Criteria
  • 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
Exclusion Criteria
  • 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