Status:
RECRUITING
"Wait-and-see" Policy for Complete Responders After Chemoradiotherapy for Rectal Cancer
Lead Sponsor:
The Netherlands Cancer Institute
Collaborating Sponsors:
Dutch Cancer Society
Conditions:
Rectal Neoplasms
Eligibility:
All Genders
18+ years
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 indic...
Detailed Description
Standard treatment for patients with locally advanced rectal cancer consists of a long course of (CRT) followed by surgical resection. Although the aim of neoadjuvant treatment in these patients is no...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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
Key Trial Info
Start Date :
May 10 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT03426397
Start Date
May 10 2017
End Date
June 1 2026
Last Update
July 29 2020
Active Locations (14)
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1
Universitair Ziekenhuis Antwerpen
Antwerp, Belgium
2
Antoni van Leeuwenhoek
Amsterdam, Netherlands, 1066CX
3
VU Medisch Centrum
Amsterdam, Netherlands
4
Amphia Ziekenhuis
Breda, Netherlands