Wait-and-see approach for rectal cancer patients after treatment
Multicentre Evaluation of the "Wait-and-see" Policy for Complete Responders After Chemoradiotherapy for Rectal Cancer
This study is testing whether some rectal cancer patients who respond well to treatment can safely skip surgery and just be monitored instead.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 220 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Netherlands Cancer Institute Academic / other |
| Drugs / interventions | radiation |
| Locations | 14 sites (Antwerp and 13 other locations) |
| Trial ID | NCT03426397 on ClinicalTrials.gov |
What this trial studies
This observational cohort study aims to gather data on the short and long-term oncological and functional outcomes of patients with rectal cancer who have achieved a complete response after neoadjuvant chemoradiotherapy. Instead of proceeding with surgical resection, selected patients will be monitored under a 'wait-and-see' policy to assess the safety and effectiveness of this approach. The study will also establish a national network of expertise centers and a registry to enhance evidence on organ preservation strategies. The goal is to provide comprehensive follow-up and support for patients considered good candidates for this treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with primary rectal cancer who have shown a complete clinical response to neoadjuvant treatment.
Not a fit: Patients with recurrent rectal cancer or those who cannot undergo MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better functional outcomes and reduced need for surgery in rectal cancer patients.
How similar studies have performed: Previous studies have indicated that a 'wait-and-see' approach can be a safe alternative for selected patients, suggesting potential success for this study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Antwerp and 13 other locations
- Universitair Ziekenhuis Antwerpen — Antwerp, Belgium (Recruiting)
- Antoni van Leeuwenhoek — Amsterdam, Netherlands (Recruiting)
- VU Medisch Centrum — Amsterdam, Netherlands (Not_yet_recruiting)
- Amphia Ziekenhuis — Breda, Netherlands (Not_yet_recruiting)
- Deventer Ziekenhuis — Deventer, Netherlands (Recruiting)
- Westfriesgasthuis — Hoorn, Netherlands (Recruiting)
- Leeuwarden Medisch Centrum — Leeuwarden, Netherlands (Not_yet_recruiting)
- Leiden University Medical Center — Leiden, Netherlands (Not_yet_recruiting)
- Maastricht University Medical Centre — Maastricht, Netherlands (Recruiting)
- Radboud UMC — Nijmegen, Netherlands (Recruiting)
- Elisabeth Tweesteden Ziekenhuis — Tilburg, Netherlands (Not_yet_recruiting)
- Diakonessenhuis — Utrecht, Netherlands (Not_yet_recruiting)
- Universitair Medisch Centrum Utrecht — Utrecht, Netherlands (Not_yet_recruiting)
- Isala Klinieken — Zwolle, Netherlands (Recruiting)
Study contacts
- Principal investigator: Geerard Beets, MD, PhD — Antoni van Leeuwenhoek - Netherlands Cancer Institute
- Study coordinator: Marit van der Sande, MD
- Email: m.vd.sande@nki.nl
- Phone: 0031205129111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.