No Surgery Trial / Two Dose-escalation Strategies

  • STATUS
    Recruiting
  • End date
    Jan 12, 2027
  • participants needed
    145
  • sponsor
    Sir Mortimer B. Davis - Jewish General Hospital
Updated on 12 March 2021

Summary

A randomized study of 145 patients. Patients with a clinical T2-3 N0 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).

Description

It is becoming clear that there is a now an international consensus that rectal cancer research efforts need to be more focused in optimizing a non-surgical approach. This concept is very relevant to an ageing patient population with multiple co-morbidities regularly seen at the Jewish General Hospital and across the province. After interim analysis on 40 patients of the pilot study a phase III study is proposed. We are therefore proposing a phase III multicentric study of 145 patients to compare the two best known radiation dose escalation strategies and to achieve a complete clinical response. 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). Patients that have a high risk of recurrence or with more advanced stages of the disease will be excluded from the study, as only the local disease is being treated. The primary outcome for this proposal is rectum preservation in treated patients.

Details
Condition Stage II Rectal Cancer
Treatment Complete responders and Non-complete responders, Chemoradiation + EBRT Boost, Chemoradiation + HDRBT Boost
Clinical Study IdentifierNCT03051464
SponsorSir Mortimer B. Davis - Jewish General Hospital
Last Modified on12 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Rectal cancer patients, clinically staged as T2-T3 by MRI or endoscopic/trans-rectal ultrasound
Rectal cancer staged as N0 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
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