"Wait-and-see" Policy for Complete Responders After Chemoradiotherapy for Rectal Cancer
Multicentre Evaluation of the "Wait-and-see" Policy for Complete Responders After Chemoradiotherapy for Rectal Cancer
1 other identifier
observational
220
2 countries
14
Brief Summary
The aim of this prospective observational cohort 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 for rectal cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2017
Longer than P75 for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 10, 2017
CompletedFirst Submitted
Initial submission to the registry
December 21, 2017
CompletedFirst Posted
Study publicly available on registry
February 8, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
ExpectedJuly 29, 2020
July 1, 2020
4.1 years
December 21, 2017
July 28, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
2-year non-regrowth disease-free survival
Absence of non-regrowth local or distant recurrence or death within 2 years of follow-up
2 years after start of wait-and-see protocol
Secondary Outcomes (6)
Number of fully operational centres
2 years after start of wait-and-see protocol
2-year local regrowth rate
2 years after start of wait-and-see protocol
2-year local control
2 years after start of wait-and-see protocol
2-year overall survival
2 years after start of wait-and-see protocol
Determination of the optimal follow-up schedule
2 years after start of wait-and-see protocol
- +1 more secondary outcomes
Study Arms (1)
Study population
Eligibility Criteria
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), as determined by MRI (including DWI) and digital rectal examination + endoscopy. Only patients who fulfill the predefined list of criteria for a clinical complete response will be considered eligible for inclusion in the study.
You may qualify if:
- Aged 18 years or older
- 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).
You may not qualify if:
- Recurrent rectal cancer
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Netherlands Cancer Institutelead
- Dutch Cancer Societycollaborator
Study Sites (14)
Universitair Ziekenhuis Antwerpen
Antwerp, Belgium
Antoni van Leeuwenhoek
Amsterdam, 1066CX, 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
Related Publications (1)
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.
PMID: 34856587DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Geerard Beets, MD, PhD
Antoni van Leeuwenhoek - Netherlands Cancer Institute
- PRINCIPAL INVESTIGATOR
Regina Beets -Tan, MD, PhD
Antoni van Leeuwenhoek - Netherlands Cancer Institute
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2017
First Posted
February 8, 2018
Study Start
May 10, 2017
Primary Completion
June 1, 2021
Study Completion (Estimated)
June 1, 2026
Last Updated
July 29, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share