Randomizing Two Radiotherapy Boost Options to Avoid Rectal Cancer Surgery
Recruiting · NCT03051464 · Interventional (participants receive a specific treatment) · Lead sponsor: Sir Mortimer B. Davis - Jewish General Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Chemoradiation + EBRT BoostChemoradiation + HDRBT BoostComplete responders and Non-complete responders
What this trial is about
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).
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2, Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 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
Where it is running
4 locations listed across 1 US state.
- UT Southwestern Medical Center - Dallas, Texas, United States
- Le Centre Hospitalier de l'Université de Montreal - Montreal, Quebec, Canada
- Jewish General Hospital - Montreal, Quebec, Canada
- Centre hospitalier universitaire de Québec - Québec, Quebec, Canada