Combined Radiotherapy for Rectal Cancer
(Whistle Trial)
Recruiting in Palo Alto (17 mi)
Overseen byTe Vuong, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Sir Mortimer B. Davis - Jewish General Hospital
Disqualifiers: Other tumors, Prior therapy, Pregnancy, others
No Placebo Group
Approved in 3 Jurisdictions
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.
12345Is 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.
12345How 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.
12345Eligibility 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
+6 more
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.
+7 more
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: External beam radiotherapy + Endorectal brachytherapyExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Jewish General HospitalMontreal, Canada
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Who Is Running the Clinical Trial?
Sir Mortimer B. Davis - Jewish General HospitalLead Sponsor
Icad, Inc.Industry Sponsor
References
High-dose-rate pre-operative endorectal brachytherapy for patients with rectal cancer. [2022]High-dose-rate endorectal brachytherapy (HDREBT) is an image guided brachytherapy treatment for patients with rectal cancer. It is based on tumor imaging with magnetic resonance in particular, which is used to choose eligible patients and improve tumor visualization. Treatment planning is performed using 3D CT simulation and treatment planning. The treatment is given on an outpatient basis and requires minimal local anesthesia. The validation of the technique was carried out through a preoperative study and is now explored as part of a radical treatment for early rectal cancer or as a boost modality. We describe technical aspects of the HDREBT and we discuss the ongoing institutional review board approved studies exploring the clinical applications of this treatment modality for patients with rectal cancer: 1) as a neoadjuvant treatment for patients with operable rectal tumor; 2) as a option to improve local control in patients with newly diagnosed rectal cancer but with previous pelvic radiation.
Toxicity outcome of endorectal brachytherapy boost in medically inoperable patients. [2020]This communication reviews results and toxicity of image-guided high-dose-rate endorectal brachytherapy (HDREBT) boost after external beam radiotherapy (ERT) in medically inoperable patients with rectal cancer.
High-dose rate endorectal brachytherapy for rectal cancer: A state-of-the-art review. [2023]Rectal cancer is a common malignancy that requires multidisciplinary treatment. By utilizing the dose-response relationship in rectal cancer radiotherapy, increasing the radiotherapy dose can improve clinical complete remission rates. High-dose rate endorectal brachytherapy (HDREBT) is a novel technique that delivers high doses of radiotherapy directly to the tumor via an endorectal applicator, sparing the adjacent normal tissues from excessive radiation exposure. HDREBT includes contact X-ray brachytherapy and high-dose-rate intracavitary brachytherapy. We introduce the latest developments in applicators and imaging techniques for HDREBT in rectal cancer and summarize the current evidence on the efficacy, safety, and feasibility of HDREBT as a neoadjuvant, definitive, or palliative treatment option for all stages of rectal cancer patients. We also discuss the potential advantages and challenges of HDREBT in achieving organ preservation and improving the quality of life of rectal cancer patients. 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. More studies are needed to optimize its dose and fractionation schemes in different clinical scenarios.
CT-based adaptive high-dose-rate endorectal brachytherapy in the preoperative treatment of locally advanced rectal cancer: Technical and practical aspects. [2018]During the last decade due to the availability of a CT scan in the brachytherapy suite, high-dose-rate endorectal brachytherapy (HDREBT) has evolved as a CT-based daily adaptive treatment. An update of the technical and practical aspects of HDREBT is provided.
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]The HERBERT study evaluated a high-dose-rate endorectal brachytherapy boost (HDREBT) after EBRT in medically inoperable/elderly patients with rectal cancer. The response-rates are promising but not without risk of toxicity. The current analysis provides a comprehensive overview of patient reported, physician reported and endoscopically observed toxicity.