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

Sponsor

The Netherlands Cancer Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT03426397

Collaborator

Dutch Cancer Society (Other)

220

Enrollment

Locations

108.7

Anticipated Duration (Months)

15.7

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Rectal Neoplasms

Detailed 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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

220 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 10, 2017

Anticipated Primary Completion Date :

Jun 1, 2021

Anticipated Study Completion Date :

Jun 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Study population

Outcome Measures

Primary Outcome Measures

2-year non-regrowth disease-free survival [2 years after start of wait-and-see protocol]
Absence of non-regrowth local or distant recurrence or death within 2 years of follow-up

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Universitair Ziekenhuis Antwerpen	Antwerp	Belgium
2	Antoni van Leeuwenhoek	Amsterdam	Netherlands	1066CX
3	VU Medisch Centrum	Amsterdam	Netherlands
4	Amphia Ziekenhuis	Breda	Netherlands
5	Deventer Ziekenhuis	Deventer	Netherlands
6	Westfriesgasthuis	Hoorn	Netherlands
7	Leeuwarden Medisch Centrum	Leeuwarden	Netherlands
8	Leiden University Medical Center	Leiden	Netherlands
9	Maastricht University Medical Centre	Maastricht	Netherlands
10	Radboud UMC	Nijmegen	Netherlands
11	Elisabeth Tweesteden Ziekenhuis	Tilburg	Netherlands
12	Diakonessenhuis	Utrecht	Netherlands
13	Universitair Medisch Centrum Utrecht	Utrecht	Netherlands
14	Isala Klinieken	Zwolle	Netherlands

Sponsors and Collaborators

The Netherlands Cancer Institute
Dutch Cancer Society

Investigators

Principal Investigator: Geerard Beets, MD, PhD, Antoni van Leeuwenhoek - Netherlands Cancer Institute
Principal Investigator: Regina Beets -Tan, MD, PhD, Antoni van Leeuwenhoek - Netherlands Cancer Institute