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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment New Swift Local Therapy, Endorectal Brachytherapy, High-Dose-Rate Endorectal Brachytherapy (HDREBT), New Swift Local Therapy for rectal cancer?

High-dose-rate endorectal brachytherapy (HDREBT) has shown promising results in achieving high complete response rates, enabling nonoperative management, improving organ preservation rates, and providing effective palliation in rectal cancer patients. It delivers high doses of radiotherapy directly to the tumor, sparing nearby healthy tissues, and has been effective as a neoadjuvant, definitive, or palliative treatment option for all stages of rectal cancer. ^{1 2 3 4 5}

Is high-dose-rate endorectal brachytherapy (HDREBT) safe for humans?

High-dose-rate endorectal brachytherapy (HDREBT) has been studied for rectal cancer and shows promising results, but it is not without risks. Some studies report toxicity, which means there can be side effects, but more research is needed to fully understand its safety. ^{1 2 3 4 5}

How is the New Swift Local Therapy treatment for rectal cancer different from other treatments?

New Swift Local Therapy, also known as high-dose-rate endorectal brachytherapy (HDREBT), is unique because it delivers high doses of radiation directly to the tumor through an applicator placed inside the rectum, minimizing exposure to surrounding healthy tissues. This approach can improve tumor control and potentially preserve the organ, offering a non-surgical option for patients. ^{1 2 3 4 5}

Research Team

Te Vuong, MD

Principal Investigator

Sir Mortimer B. Davis - Jewish General Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Poland pubmed.ncbi.nlm.nih.gov

High-dose-rate pre-operative endorectal brachytherapy for patients with rectal cancer. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Toxicity outcome of endorectal brachytherapy boost in medically inoperable patients. [2020]

3. England pubmed.ncbi.nlm.nih.gov

High-dose rate endorectal brachytherapy for rectal cancer: A state-of-the-art review. [2023]

4. United States 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. [2018]

5. Ireland 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. [2019]