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No Surgery Trial / Two Dose-escalation Strategies

Phase 2
Recruiting
Conditions
Stage II Rectal Cancer
Interventions
Procedure: Complete responders and Non-complete responders
Radiation: Chemoradiation + EBRT Boost
Radiation: Chemoradiation + HDRBT Boost
Registration Number
NCT03051464
Lead Sponsor
Sir Mortimer B. Davis - Jewish General Hospital
Brief Summary

A randomized study of 131 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).

Detailed 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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
131
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Chemoradiation + HDRBT BoostComplete responders and Non-complete respondersstandard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and followed by a brachytherapy boost of 30 Gy in 3 fractions; Complete responders and Non-complete responders
Chemoradiation + EBRT BoostComplete responders and Non-complete respondersstandard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy in 5; Complete responders and Non-complete responders
Chemoradiation + EBRT BoostChemoradiation + EBRT Booststandard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy in 5; Complete responders and Non-complete responders
Chemoradiation + HDRBT BoostChemoradiation + HDRBT Booststandard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and followed by a brachytherapy boost of 30 Gy in 3 fractions; Complete responders and Non-complete responders
Primary Outcome Measures
NameTimeMethod
TME-free survival2 years post treatment

Time from date of randomization to either TME or death in the intention to treat population

Secondary Outcome Measures
NameTimeMethod
Disease-free survival5 years post treatment

The time between the date of randomization and recurrence, either in the pelvis or metastases. Patients without an event will be censored at the last date the patient was known to be disease-free.

Overall survival5 years post treatment

The time between date of randomization and date of death due to any causes.

Local Recurrence2 years post treatment

Number of participants with Local recurrence as assessed by tests during follow-up visits.

Overall Quality of life5 years post treatment

Quality of life Questionnaires over different time point

Trial Locations

Locations (4)

Hôpital Pierre Boucher

🇨🇦

Longueuil, Quebec, Canada

Centre hospitalier universitaire de Québec

🇨🇦

Québec City, Quebec, Canada

Jewish General Hospital

🇨🇦

Montreal, Quebec, Canada

Le Centre Hospitalier de l'Université de Montreal

🇨🇦

Montréal, Quebec, Canada

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