Watch and Wait Management on Rectal Cancer Patients Using New Swift Local Therapy
NCT ID: NCT04336202
Last Updated: 2024-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
45 participants
INTERVENTIONAL
2024-08-31
2028-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Patients With Rectal Cancer: a "Wait-and-see" Approach
NCT03001362
Study of Radiation Therapy in Combination With Xeloda, for Initially Metastatic, Low and Middle Rectal Cancer
NCT03634202
IMRT Versus 3DCRT for Locally Advanced Rectal Cancer, Prospective Phase II Study.
NCT06160570
Intraoperative Electron Radiotherapy in Rectal Cancer - A Feasibility Trial
NCT05877352
Study of Therapeutic Targets Tailored Ch and IMRT as Neoadjuvant Treatment in Rectal Carcinoma Patients
NCT01366118
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
External beam radiotherapy + Endorectal brachytherapy
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
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
External beam radiotherapy + Endorectal brachytherapy
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Icad, Inc.
INDUSTRY
Sir Mortimer B. Davis - Jewish General Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr. Te Vuong
Radiation Oncologist
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Te Vuong, MD
Role: PRINCIPAL_INVESTIGATOR
Sir Mortimer B. Davis - Jewish General Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Jewish General Hospital
Montreal, Quebec, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2020-2230
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.