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Recruiting Phase 2 / Phase 3

Randomizing Two Radiotherapy Boost Options to Avoid Rectal Cancer Surgery

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About this study

A randomized study of 131 patients. Patients with a clinical T2-3 N0-1 rectal cancer will be randomized to two arms (arm A: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy compared to arm B: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and followed by a brachytherapy boost of 30 Gy in 3 fractions).

Condition
Stage II Rectal Cancer, Organ Preservation, Non-operative Treatment, Rectal Cancer (Stage III), Rectal Cancer Patients
Tested
Complete responders and Non-complete responders, Chemoradiation + EBRT Boost, Chemoradiation + HDRBT Boost
Sponsor
Sir Mortimer B. Davis - Jewish General Hospital

Who can join

Age
18 to 80 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 16

  • Minimum age: 18 years
  • Maximum age: 80 years
  • Study condition: Stage II Rectal Cancer, Organ Preservation, Non-operative Treatment, Rectal Cancer (Stage III), Rectal Cancer Patients
  • Rectal cancer patients, clinically staged as T2-T3a,b N0-1 by MRI or endoscopic/trans-rectal ultrasound
  • Rectal cancer staged as N0-1 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 5

  • 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

Where

4 sites, 4 recruiting

Jewish General Hospital

Montreal, Quebec, Canada

Recruiting

Le Centre Hospitalier de l'Université de Montreal

Montreal, Quebec, Canada

Recruiting

Centre hospitalier universitaire de Québec

Québec, Quebec, Canada

Recruiting

UT Southwestern Medical Center

Dallas, Texas, United States

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.