Radical External Beam Chemoradiation in Patients With Rectal Cancer: a Wait-and-see Approach

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Patients with histologically proven adenocarcinoma of the rectum will receive pelvic radiotherapy to a dose of 45Gy in 25 fractions with a tumor boost to a dose of 9Gy in 5 fractions (thus total of 54Gy/30Fx to the primary tumor), combined with radio sensitizing chemotherapy. Patients will then be closely monitored, through endoscopy and imaging, for response to treatment and relapse. Salvage oncologic surgery to be offered if there is failure to achieve complete clinical response or in the event of a loco regional relapse.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• Pelvic MRI defined disease (at least one of the following):

‣ mesorectum involved or breached - includes involvement of adjacent organ (s) (T3-T4)

⁃ involvement of muscularis propria (T2)

⁃ extra-mural vascular invasion

⁃ tumour deposit within the mesorectum

⁃ one or more involved mesorectal lymph node

• Patients are considered medically fit for oncologic resection

• ECOG performance status 0 or 1

• No evidence of established metastatic disease (CT chest and abdomen)

• Absolute neutrophil count \>1.5x109/L; platelets \>100x109/L,

• Serum transaminase \<3 x ULN;

• Adequate renal function (Cockroft Gault estimation \>50 mL/min)

• Bilirubin \<1.5 x ULN

• Ability to comply with oral medication

• Willingness and ability to give informed consent and comply with treatment and follow up schedule

• Age 18 or over

Locations
Other Locations
Canada
McGill University Health Center-Cedars Cancer Centre
RECRUITING
Montreal
McGill University Health Centre- Cedars Cancer Centre
RECRUITING
Montreal
Contact Information
Primary
Neil Kopek, M.D.
neil.kopek@muhc.mcgill.ca
514-934-4440
Backup
Marianna Perna, CCRP,CCRC
marianna.perna@muhc.mcgill.ca
514-934-1934
Time Frame
Start Date: 2015-03
Estimated Completion Date: 2026-01
Participants
Target number of participants: 48
Treatments
Experimental: Radical External Beam RT for Colorectal Ca
A single arm consisting of: Radical external beam RT dose of 54 Gy in 30fx with radiosensitizing chemotherapy as per institutional standard
Related Therapeutic Areas
Sponsors
Leads: McGill University Health Centre/Research Institute of the McGill University Health Centre

This content was sourced from clinicaltrials.gov