Clinical trial · Observational
"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
NCT03426397CI-TRIAL-00046261unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Study population
Primary outcomes (1)
- measure
- 2-year non-regrowth disease-free survival
- timeFrame
- 2 years after start of wait-and-see protocol
- description
- Absence of non-regrowth local or distant recurrence or death within 2 years of follow-up
Secondary outcomes (6)
- measure
- Number of fully operational centres
- timeFrame
- 2 years after start of wait-and-see protocol
- description
- Number of operational centres who can deliver high quality organ preserving care in rectal cancer in the Netherlands
- measure
- 2-year local regrowth rate
- timeFrame
- 2 years after start of wait-and-see protocol
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMeyer 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 34856587