RecruitingNCT03426397

"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

Sponsor

The Netherlands Cancer Institute

Enrollment

220 participants

Start Date

May 10, 2017

Study Type

OBSERVATIONAL

Conditions

Rectal Neoplasms

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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 Criteria4

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

Locations(14)

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

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NCT03426397

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