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

NCT03001362 | Recruiting

• 1 other identifier: 14-407 GEN
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

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.

Conditions

Colorectal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Feasibility of a "wait and see" approach

  Rate of failure to achieve CR or the rate of recurrence after achieving CR

  One year

Study Arms (1)

Radical External Beam RT for Colorectal Ca

EXPERIMENTAL

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

Interventions

Radical external beam radiotherapy RADIATION

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.

Also known as: Radiosensitizing chemotherapy

Radical External Beam RT for Colorectal Ca

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (2)

McGill University Health Center-Cedars Cancer Centre

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

McGill University Health Centre- Cedars Cancer Centre

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

Related Publications (24)

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• Gervaz PA, Wexner SD, Pemberton JH. Pelvic radiation and anorectal function: introducing the concept of sphincter-preserving radiation therapy. J Am Coll Surg. 2002 Sep;195(3):387-94. doi: 10.1016/s1072-7515(02)01308-x. No abstract available.

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• Maas M, Beets-Tan RG, Lambregts DM, Lammering G, Nelemans PJ, Engelen SM, van Dam RM, Jansen RL, Sosef M, Leijtens JW, Hulsewe KW, Buijsen J, Beets GL. Wait-and-see policy for clinical complete responders after chemoradiation for rectal cancer. J Clin Oncol. 2011 Dec 10;29(35):4633-40. doi: 10.1200/JCO.2011.37.7176. Epub 2011 Nov 7.

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• Glynne-Jones R, Hughes R. Critical appraisal of the 'wait and see' approach in rectal cancer for clinical complete responders after chemoradiation. Br J Surg. 2012 Jul;99(7):897-909. doi: 10.1002/bjs.8732. Epub 2012 Apr 27.

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MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Neil Kopek, M.D.

  Radiation Oncologist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neil Kopek, M.D.

CONTACT

514-934-4440; neil.kopek@muhc.mcgill.ca

Marianna Perna, CCRP,CCRC

CONTACT

514-934-1934; marianna.perna@muhc.mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: December 23, 2016
• Study Start: March 1, 2015
• Primary Completion: July 31, 2025
• Study Completion: January 1, 2026
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)