Combined Radiotherapy for Rectal Cancer

(Whistle Trial)

Overseen By Luciana Poggi, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sir Mortimer B. Davis - Jewish General Hospital

Disqualifiers: Other tumors, Prior therapy, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for treating rectal cancer using a combination of external beam radiotherapy and endorectal brachytherapy, known as New Swift Local Therapy. The goal is to determine if a new applicator for delivering brachytherapy can improve treatment time and quality of life for patients. Suitable candidates have been diagnosed with rectal adenocarcinoma, cannot undergo surgery or chemotherapy due to medical reasons, and have tumors that meet specific criteria, such as being less than 5 cm long and non-blocking.

As an unphased trial, this study provides patients the opportunity to explore innovative treatment options that could enhance their quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this new applicator for endorectal brachytherapy is safe?

Research has shown that high-dose-rate endorectal brachytherapy, a type of internal radiation treatment, is generally safe. Studies have found that this therapy can improve outcomes for patients with rectal cancer, helping to avoid surgery and preserve organs. Some reports highlight excellent results without major side effects.

As with any treatment, side effects can occur. Common ones include digestive issues, but these are usually manageable. Patients generally maintain a good quality of life during and after treatment.

The new device used in this trial has already received approval from Health Canada, indicating it has met safety standards in other studies. Overall, endorectal brachytherapy is a promising option for treating rectal cancer with a good safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the new swift local therapy for rectal cancer because it combines external beam radiotherapy with endorectal brachytherapy, using a new applicator. Unlike the standard treatment that often involves chemotherapy, this approach focuses solely on targeted radiotherapy, potentially reducing systemic side effects. The endorectal brachytherapy method delivers radiation directly to the tumor site, which might enhance precision and effectiveness while preserving healthy tissue. This innovative delivery could lead to quicker recovery times and improved patient outcomes, offering a promising alternative to conventional treatments.

What evidence suggests that this new applicator for endorectal brachytherapy is effective for rectal cancer?

Research has shown that endorectal brachytherapy, a type of internal radiation treatment, holds promise for rectal cancer. Studies have found high rates of complete response, meaning the cancer becomes undetectable after treatment. This method preserves the organ and delivers excellent results without surgery. In this trial, participants will receive external beam radiotherapy followed by endorectal brachytherapy with a new applicator. This new tool aims to speed up treatment and enhance patients' quality of life. Overall, current evidence supports the effectiveness of this therapy in treating rectal cancer. ^{1 2 3 5 6}

Who Is on the Research Team?

Te Vuong, MD

Principal Investigator

Sir Mortimer B. Davis - Jewish General Hospital

Are You a Good Fit for This Trial?

This trial is for adults over 18 with invasive rectal adenocarcinoma, diagnosed without removing most of the tumor. The cancer must be palpable or visible via proctoscope, within 15 cm from the anal verge, and clinically staged as T2-T3 N1+. Patients should be unfit for surgery/chemotherapy due to medical conditions and geographically available for follow-up.

Inclusion Criteria

I cannot undergo surgery or chemotherapy due to my health conditions.

I am older than 18 years.

Patient must consent to be in the study and consent form must be signed, witnessed and dated prior to registration

Exclusion Criteria

My cancer is located in the anal canal.

Patient who demonstrate prior to randomization, evidence of free perforation, as manifested by free fluid in the abdomen

I have had treatment for rectal cancer before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiotherapy

Participants receive external beam radiotherapy

4-6 weeks

Weekly visits for radiotherapy sessions

Endorectal Brachytherapy

Participants receive three treatments of endorectal brachytherapy using a new applicator

3 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Regular follow-up visits to assess toxicity and tumor response

What Are the Treatments Tested in This Trial?

Interventions

• New Swift Local Therapy

Trial Overview The study tests a new endorectal brachytherapy applicator approved by Health Canada against traditional external beam radiotherapy combined with older brachytherapy methods. It aims to improve quality of life and treatment efficiency in rectal cancer management.

How Is the Trial Designed?

Group I: External beam radiotherapy + Endorectal brachytherapy Experimental Treatment 1 Intervention

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.

New Swift Local Therapy is already approved in Canada, European Union, United States for the following indications:

Approved in Canada as Endorectal Brachytherapy for:

• Rectal Cancer

Approved in European Union as High-Dose-Rate Endorectal Brachytherapy (HDREBT) for:

• Rectal Cancer

Approved in United States as Endorectal Brachytherapy for:

• Rectal Cancer

Who Is Running the Clinical Trial?

Sir Mortimer B. Davis - Jewish General Hospital

Lead Sponsor

Trials

61

Recruited

25,800+

Icad, Inc.

Industry Sponsor

Trials

5

Recruited

1,300+

Published Research Related to This Trial

In a study of 38 elderly patients with inoperable rectal cancer, high-dose-rate endorectal brachytherapy (HDREBT) following external beam radiotherapy (EBRT) showed promising tumor response rates but resulted in significant toxicity, with 68.4% experiencing acute grade 2 proctitis and 13.2% experiencing grade 3 proctitis.

The most severe toxicities, including late grade 2 and ≥3 proctitis, were observed in 48% and 40% of patients respectively, indicating that while HDREBT can be effective, the risks of severe side effects must be carefully considered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of clinical and endoscopic toxicity after external beam radiotherapy and endorectal brachytherapy in elderly patients with rectal cancer treated in the HERBERT study. Rijkmans, EC., van Triest, B., Nout, RA., et al.[2019]

High-dose-rate endorectal brachytherapy (HDREBT) is an effective preoperative treatment for locally advanced rectal cancer, delivering a total of 26 Gy in four daily applications while utilizing daily CT scans for treatment planning and optimization.

This CT-based adaptive approach not only provides excellent local control of the cancer but also maintains a favorable safety profile, minimizing toxicity for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CT-based adaptive high-dose-rate endorectal brachytherapy in the preoperative treatment of locally advanced rectal cancer: Technical and practical aspects. Nout, RA., Devic, S., Niazi, T., et al.[2018]

High-dose-rate endorectal brachytherapy (HDREBT) is a promising outpatient treatment for rectal cancer that utilizes advanced imaging techniques like MRI for better tumor visualization and patient selection.

Current studies are investigating HDREBT's effectiveness as a neoadjuvant treatment for operable rectal tumors and as a method to enhance local control in patients with newly diagnosed rectal cancer who have previously undergone pelvic radiation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-dose-rate pre-operative endorectal brachytherapy for patients with rectal cancer. Vuong, T., Devic, S.[2022]

In a study of 18 medically inoperable rectal cancer patients, the combination of external beam radiotherapy (ERT) followed by high-dose-rate endorectal brachytherapy (HDREBT) resulted in manageable toxicity levels, with early and late grade 3 toxicity rates of 11% and 19%, respectively.

The treatment, which delivered a median total dose of 66 Gy, demonstrated that with proper technique, this combined approach is safe and effective for patients who cannot undergo surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toxicity outcome of endorectal brachytherapy boost in medically inoperable patients. Chiang, CL., Lee, SF., Lee, VW., et al.[2020]

High-dose rate endorectal brachytherapy (HDREBT) effectively delivers targeted radiation to rectal tumors, improving complete remission rates while minimizing damage to surrounding healthy tissues.

HDREBT has shown promising results in enhancing organ preservation and quality of life for rectal cancer patients, but further research is needed to refine treatment protocols for various clinical situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-dose rate endorectal brachytherapy for rectal cancer: A state-of-the-art review. Cheng, T., Peng, R., Qu, A., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10637059/

High‐dose rate endorectal brachytherapy for rectal cancer HDREBT has shown promising results in achieving high complete response rates, enabling nonoperative management, improving organ preservation ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40441490/

Endorectal high-dose-rate brachytherapy boost in rectal ... Excellent outcomes were described after using endorectal high-dose-rate (HDR) brachytherapy boost in the non-operative management of rectal cancer.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT01226979?cond=rectum+cancer&aggFilters=status%3A

Study of High-Dose-Rate Endorectal Brachytherapy ... This research is being done to see how effective high-dose rate endorectal brachytherapy (HDRBT) is in treating cancer of the lowest part of the bowel ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT01226979/study-of-high-dose-rate-endorectal-brachytherapy-hdrbt-in-the-treatment-of-locally-advanced-low-rectal-cancer

Study of High-Dose-Rate Endorectal Brachytherapy ... This research is being done to see how effective high-dose rate endorectal brachytherapy (HDRBT) is in treating cancer of the lowest part of ...

5. papers.ssrn.com papers.ssrn.com/sol3/papers.cfm?abstract_id=5168981

Endorectal High-Dose-Rate Brachytherapy Boost in Rectal ... During a median follow-up of 22 months, eight patients (32%) experienced regrowth and salvage R0 surgery was performed in seven patients. Non- ...

6. map.amegroups.org map.amegroups.org/article/view/8790/html

AB053. SOH24AB_227. Safety and efficacy of neo-adjuvant ... High-dose rate endorectal brachytherapy may represent a safe and effective method of improving oncological outcomes in patients with locally advanced rectal ...