"Wait-and-see" Policy for Complete Responders After Chemoradiotherapy for Rectal Cancer

Rectal Neoplasms Clinical Trial

Official title:

Multicentre Evaluation of the "Wait-and-see" Policy for Complete Responders After Chemoradiotherapy for Rectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03426397
• Other study ID #: M16WAS
• Status: Recruiting
• Start date: May 10, 2017
• Est. completion date: June 1, 2026

Study information

• Verified date: July 2020
• Source: The Netherlands Cancer Institute
• Contact: Marit van der Sande, MD
• Phone: 0031205129111
• Email: m.vd.sande[@]nki.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 not organ preservation, but rather to provide improved local control, in the tumour disappears completely. Studies from Maastricht, the UK and Brazil have shown that in selected patients with a clinical complete response after CRT, a "wait-and-see" policy without any surgery could be a safe alternative with comparable long-term outcome and better functional outcome compared to patients who had surgery.

The main objective of the 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. Additional aims are: to set up a national network with expertise centres in the 'wait-and-see' treatment of rectal cancer; to set up a national registry for organ preservation treatment that will generate more evidence on the management and oncological outcome of patients evaluated and treated with organ preservation and [3] to offer through this network to all patients who are considered good candidates this 'wait-and-see' approach using the most up to date tools for selection and follow-up.

Study design: multicenter prospective observational cohort study and implementation study. Study population: The population will consist of patients, aged 18 years or older, with rectal cancer who after a long course of CRT or a short course of radiation with a long waiting interval have a clinical complete response (ycT0N0).

The main study endpoint is 2-year non-regrowth disease-free survival. Secondary endpoints are [1] the number of fully operational centres who can deliver high quality organ preserving care in rectal cancer in the Netherlands, [2] 2-year regrowth rate, [3] 2-year local control, [4] 2-year overall survival, [5] determination of the optimal follow-up schedule and [6] quality of life.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In the majority of patients who participate in the study, major surgery and the associated morbidity can be avoided. Although scientific proof shows "wait-and-see" only comes with a small risk with adequate selection and follow up, the exact risk is not yet well established and needs to be confirmed by this study. The benefit-risk ratio for this study is regarded as favourable.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: June 1, 2026
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rectal Neoplasms

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Antwerpen	Antwerp
Netherlands	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

Sponsors (2)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute	Dutch Cancer Society

Countries where clinical trial is conducted

Belgium,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-year non-regrowth disease-free survival	Absence of non-regrowth local or distant recurrence or death within 2 years of follow-up	2 years after start of wait-and-see protocol
Secondary	Number of fully operational centres	Number of operational centres who can deliver high quality organ preserving care in rectal cancer in the Netherlands	2 years after start of wait-and-see protocol
Secondary	2-year local regrowth rate	The proportion of local regrowth	2 years after start of wait-and-see protocol
Secondary	2-year local control	Absence of local recurrence(unresectable regrowth, resected with R1, or requiring more extensive than TME surgery) or death	2 years after start of wait-and-see protocol
Secondary	2-year overall survival	Absence of death	2 years after start of wait-and-see protocol
Secondary	Determination of the optimal follow-up schedule	A balance between early detection of recurrence and compliance to follow-up	2 years after start of wait-and-see protocol
Secondary	Quality of life	Quality of life (general health, disease specific and functional outcomes)	At 3 months, 1 year, 2 years and 5 years after the start of wait-and-see protocol