Watch and Wait Management on Rectal Cancer Patients Using New Swift Local Therapy

NCT04336202 | Suspended

• 1 other identifier: 2020-2230
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Within our institution, the principal investigator have acquired expertise in endorectal brachytherapy, a localized treatment for colorectal cancer. Until now a modality which uses an endorectal applicator has been used, which has certain limitations. In the context of this study, a new applicator will be used which is already approved by Health Canada for endorectal brachytherapy, thereby improving the participant's quality of life and optimizing treatment time.

Conditions

Rectal Cancer; Comorbidities and Coexisting Conditions; Inoperable Disease; Brachytherapy

Outcome Measures

Primary Outcomes (3)

• The feasibility of the new device

  To measure the percentage (%) of clinical complete responders versus non-complete clinical responders and compare it to the percentage of an already proven device to determine if the new device can be used to treat rectal cancer patients. The cancer response will be assessed by rectoscopy, biopsy and imaging.

  2 years post treatment

• Toxicity using the new device

  Use the CTCAE guidelines to measure the percentage (%) of toxicity (G3 and above) of this novel X-Ray device. All grade 3 post-treatment complications will be reported (Proctitis, rectal bleeding, diarrhea). The toxicity will be assessed by the clinician during the follow-up visits. An early stopping rule for possible severe toxicity during and post treatment toxicity will be used in this study. The following early stopping rules will be applied to test the null hypothesis that the proportion of severe toxicity is less or equal to 25 % at 0.05: * 3 severe toxicities (G3-4) out of the first 12 evaluable patients or * 5 severe toxicities (G3-4) out of the first 22 evaluable patients or * 7 severe toxicities (G3-4) out of the first 36 evaluable patients.

  2 years post treatment

• Workload

  To evaluate the workload of this modality in regards to time management (the time required to treat patients (pre-treatment and during treatment) and the number of ressources required. The principal investigator will compare it to an already existent equivalent treatment.

  2 years post treatment

Secondary Outcomes (2)

• Tumor response

  At clinical evaluation, 13 weeks since beginning of treatments

• Local control

  2 years post treatment

Study Arms (1)

External beam radiotherapy + Endorectal brachytherapy

OTHER

In this study, all participants will receive a treatment of external beam radiotherapy without chemotherapy, which will be followed by three (3) treatments of endorectal brachytherapy with the new applicator.

Radiation: External beam radiotherapy + Endorectal brachytherapy

Interventions

External beam radiotherapy + Endorectal brachytherapy RADIATION

In this study, all participants will receive a treatment of external beam radiotherapy without chemotherapy, which will be followed by three (3) treatments of endorectal brachytherapy with the new applicator.

External beam radiotherapy + Endorectal brachytherapy

Eligibility Criteria

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

You may qualify if:

• Patients with histologic diagnosis by proctoscopic biopsy of invasive rectal adenocarcinoma will be considered for entry in this study.
• Patient in whom the diagnosis of invasive rectal cancer has been obtained by incisional biopsy (surgical or endoscopic biopsy) that the majority of the tumor has not been removed .
• The tumor should be either palpable by clinical rectal exam or accessible via a rigid proctoscope, and its proximal border should be located no more than 15 cm from the anal verge.
• Rectal cancer clinically stage as T2-T3 N1+ by MRI or endoscopic ultrasound.
• Tumor of 5 cm or less length, non obstructive
• Patient is not suitable for surgery nor chemotherapy due to medical conditions
• Patient must consent to be in the study and consent form must be signed, witnessed and dated prior to registration .
• Patients must be accessible geographically for follow up.
• Adults older than 18 years of age

You may not qualify if:

• Patient with malignant rectal tumors other than adenocarcinoma, i.e, sarcoma, lymphoma, carcinoid, squamous cell, cloacogenic, etc.
• Patient who demonstrate prior to randomization, evidence of free perforation, as manifested by free fluid in the abdomen.
• Patient who are curable by standard of care with either surgery or eligible for the Morpheus study.
• Patient who have received any previous therapy (radiation , chemotherapy) for rectal cancer.
• Patient whose tumor is fixed by clinical examination to surrounding structures, precluding the possibility of adequate surgical resection even with pelvic exenteration.
• Patient with a performance status of 3 or 4.
• Patient with tumor involving the anal canal.
• Patient who are pregnant at the time of randomization.
• Patient with psychiatric or addictive disorders that would preclude obtaining informed consent.
• Patient who have multiple primary tumors involving both the colon and rectum that would preclude them from being classified as having only rectal cancer.

Sponsors & Collaborators

• Sir Mortimer B. Davis - Jewish General Hospital: lead

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Related Publications (6)

• Rutten HJ, den Dulk M, Lemmens VE, van de Velde CJ, Marijnen CA. Controversies of total mesorectal excision for rectal cancer in elderly patients. Lancet Oncol. 2008 May;9(5):494-501. doi: 10.1016/S1470-2045(08)70129-3.

  PMID: 18452860 BACKGROUND

• Dekker JW, van den Broek CB, Bastiaannet E, van de Geest LG, Tollenaar RA, Liefers GJ. Importance of the first postoperative year in the prognosis of elderly colorectal cancer patients. Ann Surg Oncol. 2011 Jun;18(6):1533-9. doi: 10.1245/s10434-011-1671-x. Epub 2011 Mar 29.

  PMID: 21445672 BACKGROUND

• Garant A, Magnan S, Devic S, Martin AG, Boutros M, Vasilevsky CA, Ferland S, Bujold A, DesGroseilliers S, Sebajang H, Richard C, Vuong T. Image Guided Adaptive Endorectal Brachytherapy in the Nonoperative Management of Patients With Rectal Cancer. Int J Radiat Oncol Biol Phys. 2019 Dec 1;105(5):1005-1011. doi: 10.1016/j.ijrobp.2019.08.042. Epub 2019 Aug 30.

  PMID: 31476417 BACKGROUND

• Liang LH, Tomic N, Vuong T, Aldelaijan S, Bekerat H, DeBlois F, Seuntjens J, Devic S. Physics aspects of the Papillon technique-Five decades later. Brachytherapy. 2018 Jan-Feb;17(1):234-243. doi: 10.1016/j.brachy.2017.09.016.

  PMID: 29102741 BACKGROUND

• Gerard JP, Chapet O, Ramaioli A, Romestaing P. Long-term control of T2-T3 rectal adenocarcinoma with radiotherapy alone. Int J Radiat Oncol Biol Phys. 2002 Sep 1;54(1):142-9. doi: 10.1016/s0360-3016(02)02879-1.

  PMID: 12182984 BACKGROUND

• Sun Myint A, Smith FM, Gollins SW, Wong H, Rao C, Whitmarsh K, Sripadam R, Rooney P, Hershman MJ, Fekete Z, Perkins K, Pritchard DM. Dose escalation using contact X-ray brachytherapy (Papillon) for rectal cancer: does it improve the chance of organ preservation? Br J Radiol. 2017 Dec;90(1080):20170175. doi: 10.1259/bjr.20170175. Epub 2017 Nov 10.

  PMID: 28937269 BACKGROUND

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Te Vuong, MD

  Sir Mortimer B. Davis - Jewish General Hospital

  PRINCIPAL INVESTIGATOR

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: Radiation Oncologist

Study Record Dates

• First Submitted: February 20, 2020
• First Posted: April 7, 2020
• Study Start: October 27, 2020
• Primary Completion (Estimated): October 27, 2026
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 24, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)