"Wait-and-see" Policy for Complete Responders After Chemoradiotherapy for Rectal Cancer
NCT ID: NCT03426397
Last Updated: 2020-07-29
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
220 participants
OBSERVATIONAL
2017-05-10
2026-06-01
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.
"Watch and Wait" After Neo-adjuvant Chemoradiotherapy for Primary Locally Advanced Rectal Cancer.
NCT03402477
Watch and Wait as Treatment for Patients With Rectal Cancer
NCT03125343
Validation of a Predictive Model After Complete Response in Rectal Cancer
NCT00969657
Watchful Waiting. An Observational Study of Patients With Rectal Cancer After Concomitant Radiation and Chemotherapy
NCT00952926
Minimal Invasive Strategies for Good and Complete Response to Chemoradiation in Rectal Cancer
NCT00939666
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The main objective of the study is to provide short and long term oncological and functional outcome data on organ preserving treatment in good responders after a standard indication for neoadjuvant (chemo)radiation. Additional aims are: to set up a national network with expertise centres in the 'wait-and-see' treatment of rectal cancer; to set up a national registry for organ preservation treatment that will generate more evidence on the management and oncological outcome of patients evaluated and treated with organ preservation and \[3\] to offer through this network to all patients who are considered good candidates this 'wait-and-see' approach using the most up to date tools for selection and follow-up.
Study design: multicenter prospective observational cohort study and implementation study. Study population: The population will consist of patients, aged 18 years or older, with rectal cancer who after a long course of CRT or a short course of radiation with a long waiting interval have a clinical complete response (ycT0N0).
The main study endpoint is 2-year non-regrowth disease-free survival. Secondary endpoints are \[1\] the number of fully operational centres who can deliver high quality organ preserving care in rectal cancer in the Netherlands, \[2\] 2-year regrowth rate, \[3\] 2-year local control, \[4\] 2-year overall survival, \[5\] determination of the optimal follow-up schedule and \[6\] quality of life.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In the majority of patients who participate in the study, major surgery and the associated morbidity can be avoided. Although scientific proof shows "wait-and-see" only comes with a small risk with adequate selection and follow up, the exact risk is not yet well established and needs to be confirmed by this study. The benefit-risk ratio for this study is regarded as favourable.
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.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Study population
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Primary rectal cancer (pathologically confirmed)
* Treated with neoadjuvant (chemo)radiotherapy
* Clinical complete response (ycT0N0) to neoadjuvant treatment, as determined clinically (digital rectal examination, endoscopy) and radiologically (diffusion weighted imaging-MRI).
* Informed consent and capability of giving informed consent; before informed consent is obtained the patient will be extensively informed about the fact that 'wait-and-see' instead of conventional surgery is not accepted yet by most physicians and that the risks and benefits from these strategies have not been fully determined yet. These issues will be discussed in the patient information form as well.
* Comprehension of the alternative strategies and risks are clear to the patient (in other words that the patient understands the experimental base of the study).
Exclusion Criteria
* Contra-indications for MRI. If MRI is not possible because of contra-indications (e.g. pacemaker) patients will be excluded. MRI is crucial for response evaluation and follow-up and cannot be omitted in patients that follow the 'wait-and-see policy'.
* Unable to understand or read Dutch
* Unable or unwilling to comply to the intensive follow-up schedule
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Dutch Cancer Society
OTHER
The Netherlands Cancer Institute
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Geerard Beets, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Antoni van Leeuwenhoek - Netherlands Cancer Institute
Regina Beets -Tan, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Antoni van Leeuwenhoek - Netherlands Cancer Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Universitair Ziekenhuis Antwerpen
Antwerp, , Belgium
Antoni van Leeuwenhoek
Amsterdam, , Netherlands
VU Medisch Centrum
Amsterdam, , Netherlands
Amphia Ziekenhuis
Breda, , Netherlands
Deventer Ziekenhuis
Deventer, , Netherlands
Westfriesgasthuis
Hoorn, , Netherlands
Leeuwarden Medisch Centrum
Leeuwarden, , Netherlands
Leiden University Medical Center
Leiden, , Netherlands
Maastricht University Medical Centre
Maastricht, , Netherlands
Radboud UMC
Nijmegen, , Netherlands
Elisabeth Tweesteden Ziekenhuis
Tilburg, , Netherlands
Diakonessenhuis
Utrecht, , Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, , Netherlands
Isala Klinieken
Zwolle, , Netherlands
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.
Meyer VM, Meuzelaar RR, Schoenaker IJH, de Groot JB, Reerink O, de Vos Tot Nederveen Cappel WH, Beets GL, van Westreenen HL. Delayed TME Surgery in a Watch-and-Wait Strategy After Neoadjuvant Chemoradiotherapy for Rectal Cancer: An Analysis of Hospital Costs and Surgical and Oncological Outcomes. Dis Colon Rectum. 2023 May 1;66(5):671-680. doi: 10.1097/DCR.0000000000002259. Epub 2021 Nov 24.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
M16WAS
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.