Multicentre evaluation of the wait-and-see policy for good responders after neoadjuvant (chemo)radiation for rectal cancer

Multicentre evaluation of the *wait-and-see* policy for good responders after neoadjuvant (chemo)radiation for rectal cancer - Multicentre evaluation of "Wait-and-See" policy for rectal cancer

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON55431

Enrollment

220

Registered

2016-06-30

Start date

2017-05-10

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colorectal cancer Rectal cancer rectal cancer

Interventions

Questionnaires&nbsp

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. > 18 years old 2. Patients with primary rectal cancer who underwent CRT and show clinical complete response: Clinical complete response (ycT0N0) after neo-adjuvant chemoradiation will be determined clinically (digital rectal examination, endoscopy) and radiologically (MRI) 3. Patients with a clinical good response with a small residual tumour (ycT1-2N0) who decline the recommended TME surgery 4. Comprehension of the alternative strategies and the concept of unknown risks are clear to the patient 5. Choosing for the "Wait-and-See" policy 6. Informed consent

Exclusion criteria

Exclusion criteria: 1. Recurrent rectal cancer 2. Unable or unwilling to comply to the intensive  follow-up schedule.

Design outcomes

Primary

Measure	Time frame
2-year non-regrowth disease-free survival, defined as absence of non-regrowth local or distant recurrence or death within 2 years of FU.	—

Secondary

Measure	Time frame
Secondary study endpoints are: 1. Number of fully operational centres who can deliver high quality organ preserving care in rectal cancer in the Netherlands. 2. 2-year local regrowth rate, defined as the proportion of local regrowth within 2 years of FU. 3. 2-year local control, defined as absence of local recurrence(unresectable regrowth, resected with R1, or requiring more extensive than TME surgery) or death within 2 years of FU. 4. 2-year overall survival, defined as absence of death within 2 years of FU 5. Determination of the optimal follow-up schedule with regard to a balance between early detection of recurrence and compliance to follow-up 6. National registry of all patients treated according to wait-and-see policy in the Netherlands. 7. Quality of life8. cost utility	—

Measure

Time frame

Secondary study endpoints are: 1. Number of fully operational centres who can deliver high quality organ preserving care in rectal cancer in the Netherlands. 2. 2-year local regrowth rate, defined as the proportion of local regrowth within 2 years of FU. 3. 2-year local control, defined as absence of local recurrence(unresectable regrowth, resected with R1, or requiring more extensive than TME surgery) or death within 2 years of FU. 4. 2-year overall survival, defined as absence of death within 2 years of FU 5. Determination of the optimal follow-up schedule with regard to a balance between early detection of recurrence and compliance to follow-up 6. National registry of all patients treated according to *wait-and-see* policy in the Netherlands. 7. Quality of life8. cost utility 

—

Countries

Netherlands

Contacts

Public ContactY.Q.E.R. Tankink

Antoni van Leeuwenhoek (AVL)

y.tankink@nki.nl+3120 512 9111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 6, 2026

Multicentre evaluation of the *wait-and-see* policy for good responders after neoadjuvant (chemo)radiation for rectal cancer