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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03051464
Other study ID # 16-301
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date April 25, 2017
Est. completion date January 2030

Study information

Verified date March 2024
Source Sir Mortimer B. Davis - Jewish General Hospital
Contact Emma Starr, BHSc
Phone 514-340-8222
Email emma.starr.ccomtl@ssss.gouv.qc.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 145
Est. completion date January 2030
Est. primary completion date January 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Procedure:
Complete responders and Non-complete responders
Patients that are complete responders will not have surgery. Patients that are non-complete responders will have surgery.
Radiation:
Chemoradiation + EBRT Boost
45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy in 5
Chemoradiation + HDRBT Boost
45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and followed by a brachytherapy boost of 30 Gy in 3 fractions

Locations

Country Name City State
Canada Jewish General Hospital Montreal Quebec

Sponsors (1)

Lead Sponsor Collaborator
Sir Mortimer B. Davis - Jewish General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary TME-free survival Time from date of randomization to either TME or death in the intention to treat population 2 years post treatment
Secondary Local Recurrence Number of participants with Local recurrence as assessed by tests during follow-up visits. 2 years post treatment
Secondary Disease-free survival 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. 5 years post treatment
Secondary Overall survival The time between date of randomization and date of death due to any causes. 5 years post treatment
Secondary Overall Quality of life Quality of life Questionnaires over different time point 5 years post treatment
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