Rectal CancerWhistleNCT04336202

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

A study testing External beam radiotherapy + Endorectal brachytherapy in people with Rectal Cancer and Comorbidities and Coexisting Conditions, run by Sir Mortimer B. Davis - Jewish General Hospital at 1 site in Canada.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Rectal Cancer, Comorbidities and Coexisting Conditions, Inoperable Disease
What is being tested?: External beam radiotherapy + Endorectal brachytherapy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 45 participants
Where: 1 siteCanada
Study dates: 27 Oct 2020to Jan 2028
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 9Show fewer

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

Who cannot join

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.

Show all 10Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Jewish General Hospital
Montreal, Quebec, H3T 1E2

Other trials in Canada

About this study

Official title: A Pilot Study of Dose-escalation Strategy of Radiotherapy Followed by Endorectal Brachytherapy With the Use of a New Rectal Applicator in Inoperable, Ederly Rectal Cancer Patients

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.

Read the detailed description

The main goal of this study is to treat patients using external beam radiotherapy followed by endorectal brachytherapy using a new applicator. Validating the feasibility of this new applicator, assessing the treatment time required when using it, the necessary workload required and ultimately avoid the need for surgery are our main priorities. Currently, this option is still experimental, although several patients have been treated with this method during the last ten years.

In this pilot study, 45 patients will be recruited, whom have medical conditions (co-morbidities) that make surgery very difficult, or patients that are refusing surgery.

Conditions: Rectal Cancer, Comorbidities and Coexisting Conditions, Inoperable Disease, Brachytherapy
Being tested: External beam radiotherapy + Endorectal brachytherapy
Medical subject headings: Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

External beam radiotherapy + Endorectal brachytherapyRadiation
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.

Study groups in NCT04336202
Study group	Role	What they receive
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. Receives: Radiation: External beam radiotherapy + Endorectal brachytherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 2 years post treatment

Secondary outcomes (2)

Tumor response
Number of participants (#) that are complete clinical responders
Measured: At clinical evaluation, 13 weeks since beginning of treatments
Local control
Number (#) of participants with Local control assessed during follow-up visits
Measured: 2 years post treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Oct 2020Jan 2028

First posted7 Apr 2020
Study start27 Oct 2020
Primary completion27 Oct 2026 (estimated)
Study completionJan 2028 (estimated)

Why it stopped: Issues with applicator

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Rectal CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 45 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04336202
Sponsor's protocol ID: 2020-2230
Acronym: Whistle
Status last verified: May 2025
First submitted: 20 Feb 2020
Last updated: 24 Apr 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 18452860
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.
PubMed 21445672
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.
PubMed 31476417
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.
PubMed 29102741
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.
PubMed 12182984
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.
PubMed 28937269

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Study of Dose-escalation Strategy of Radiotherapy Followed by Endorectal Brachytherapy With the Use of a New Rectal Applicator in Inoperable, Ederly Rectal Cancer Patients
ClinicalTrials.gov ID: NCT04336202
Acronym / sponsor ID: Whistle / 2020-2230
Conditions: Rectal Cancer, Comorbidities and Coexisting Conditions, Inoperable Disease, Brachytherapy
Study type: Interventional
Recruitment status: SuspendedReason stopped: Issues with applicator
Enrolment: 45 participants (estimated)
Lead sponsor: Sir Mortimer B. Davis - Jewish General HospitalUniversity, hospital or other
Study start: 27 Oct 2020 (actual)
Primary completion: 27 Oct 2026 (estimated)
Study completion: Jan 2028 (estimated)
First posted: 7 Apr 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

In this pilot study, 45 patients will be recruited, whom have medical conditions (co-morbidities) that make surgery very difficult, or patients that are refusing surgery.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
External beam radiotherapy + Endorectal brachytherapy	Other	Radiation: External beam radiotherapy + Endorectal brachytherapyIn 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (10 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
External beam radiotherapy + Endorectal brachytherapyIn 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

Primary outcome

The feasibility of the new device
Time frame: 2 years post treatment
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.
Toxicity using the new device
Time frame: 2 years post treatment
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.
Workload
Time frame: 2 years post treatment
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 secondary outcomes

Tumor response
Time frame: At clinical evaluation, 13 weeks since beginning of treatments
Local control
Time frame: 2 years post treatment

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
Background: PubMed 18452860Rutten 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.
Background: PubMed 21445672Dekker 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.
Background: PubMed 31476417Garant 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.
Background: PubMed 29102741Liang 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.
Background: PubMed 12182984Gerard 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.
Background: PubMed 28937269Sun 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Te Vuong, MD principal investigator

Sir Mortimer B. Davis - Jewish General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The feasibility of the new device (time frame: 2 years post treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04336202, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.