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Patients With Rectal Cancer: a "Wait-and-see" Approach

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ClinicalTrials.gov Identifier: NCT03001362
Recruitment Status : Recruiting
First Posted : December 23, 2016
Last Update Posted : February 24, 2020
Sponsor:
Information provided by (Responsible Party):
Neil Kopek, McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief 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.

Condition or disease Intervention/treatment Phase
Colorectal Carcinoma Radiation: Radical external beam radiotherapy Not Applicable

Detailed Description:

The combination of preoperative (chemo)radiotherapy and total mesorectal excision (TME) has been shown to reduce the risk of local recurrence in patients with resectable adenocarcinoma of the rectum. The improved local control rates come at the price of an increased risk of surgical complications, including a postoperative death rate of 2-8 percent which may reach 30 per cent at 6 months in those aged over 85 years, as well as long-term impact on anorectal, urinary and sexual function. Patients with cancers in the low rectum in close proximity to the sphincter muscles, may require a permanent stoma, which can be associated with high psychological morbidity.

Preoperative chemoradiotherapy followed by a delay to resection can produce pathological complete responses. One review of phase II and III studies identified an overall pCR rate of 13.5%, but even higher rates of pCR have been observed with doses of radiotherapy exceeding 45 Gy . Certainly patients who proceed to radical surgery after achieving a pCR with chemo radiation do have favorable long-term outcomes. But do patients whose tumor has already been sterilized by chemo radiotherapy need to proceed with radical surgery?

A number of studies have now emerged highlighting the rationale of a 'wait and see' policy for patients who achieve a complete clinical response (cCR) after chemo radiotherapy. The majority of the clinical data supporting this approach have come from Brazil. The Brazilian data suggests that observation of such patients yields survival rates similar to those of patients who undergo radical surgery with confirmation of pCR. More recent studies from the United Kingdom and the Netherlands appear to support the feasibility of this approach. To date there is no published prospectively collected data of a wait-and-see policy from a North American Centre.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Radical External Beam Chemoradiation in Patients With Rectal Cancer: a "Wait-and-see" Approach
Study Start Date : March 2015
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : September 2022

Arm Intervention/treatment
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
Radiation: Radical external beam radiotherapy
pelvic radiotherapy to a dose of 45 Gy in 25 fractions with a tumor boost to a dose of 9 Gy in 5 fractions (thus total of 54 Gy/30 fractions to the primary tumor), combined with radio sensitizing chemotherapy.
Other Name: Radiosensitizing chemotherapy




Primary Outcome Measures :
  1. Feasibility of a "wait and see" approach [ Time Frame: One year ]
    Rate of failure to achieve CR or the rate of recurrence after achieving CR



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Previous radiotherapy to the pelvis (including brachytherapy)
  • Enlarged extramesorectal nodes
  • Uncontrolled cardiorespiratory comorbidity (includes patients with inadequately controlled angina or myocardial infarction within 6 months of randomisation)
  • T1N0 disease without extra-mural venous invasion
  • Unequivocal evidence of metastatic disease (includes resectable metastases)
  • Major impairment of bowel function without defunctioning stoma/ileostomy (baseline grade 3 diarrhoea or clinically significant faecal incontinence)
  • History of another malignancy within the last 5 years except successfully treated basal cell cancer of skin or carcinoma in situ of uterine cervix.
  • Known dihydropyrimidine dehydrogenase deficiency
  • Known Gilberts disease (hyperbilirubinaemia)
  • Taking warfarin or phenytoin or sorivudine
  • Gastrointestinal disorder which would interfere with oral therapy and its bioavailability
  • Pregnant, lactating, or pre-menopausal women not using adequate contraception
  • Unfit to receive any study treatment or subsequent surgical resection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03001362


Contacts
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Contact: Neil Kopek, M.D. 514-934-4440 neil.kopek@muhc.mcgill.ca
Contact: Marianna Perna, CCRP,CCRC 514-934-1934 ext 43191 marianna.perna@muhc.mcgill.ca

Locations
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Canada, Quebec
McGill University Health Centre- Cedars Cancer Centre Recruiting
Montreal, Quebec, Canada, H4A 3J1
Contact: Neil Kopek, M.D.    514-934-4440    neil.kopek@muhc.mcgill.ca   
Contact: Marianna Perna, CCRP, CCRC    514-934-1934 ext 43191    marianna.perna@muhc.mcgill.ca   
Principal Investigator: Neil Kopek, M.D.         
McGill University Health Center-Cedars Cancer Centre Recruiting
Montréal, Quebec, Canada, H4A 3J1
Contact: Marianna Perna, CCRP,CCRC    514-934-1934 ext 43191    marianna.perna@muhc.mcgill.ca   
Contact: Tatiana Carvalho, CCRP    514-934-1934 ext 43698    tatiana.carvalho@muhc.mcgill.ca   
Sub-Investigator: Sergio Faria, M.D.         
Sub-Investigator: Tarek Hijal, M.D.         
Sub-Investigator: Caroline Reinhart, M.D.         
Sub-Investigator: Giovanni Artho, M.D.         
Sub-Investigator: Jamil Asselah, M.D.         
Sub-Investigator: Ragu Rajan, M.D.         
Sub-Investigator: Marie Van-Huyse, M.D.         
Sub-Investigator: Sender Lieberman, M.D.         
Sub-Investigator: Patrick Charlebois, M.D.         
Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
Investigators
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Principal Investigator: Neil Kopek, M.D. Radiation Oncologist
Publications:

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Responsible Party: Neil Kopek, Principal Investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT03001362    
Other Study ID Numbers: 14-407 GEN
First Posted: December 23, 2016    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Colonic Diseases