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Rectal NeoplasmsNCT03426397

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

An observational study of Rectal Neoplasms, run by The Netherlands Cancer Institute at 14 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rectal Neoplasms
How many people
220 participants
Where
14 sitesin 2 countries
Study dates
10 May 2017to 1 Jun 2026
How long will I take part?
5 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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), as determined by MRI (including DWI) and digital rectal examination + endoscopy. Only patients who fulfill the predefined list of criteria for a clinical complete response will be considered eligible for inclusion in the study.

Who may be able to join

  • 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).

Who cannot join

  • 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

Trial locations and contacts

14 sites in 2 countries.

Marit van der Sande, MD contact

0031205129111

m.vd.sande@nki.nl

14 sites in 2 countries

Netherlands13 sites, 13 recruiting

  • Antoni van Leeuwenhoek

    Amsterdam, 1066CX

    Marit van der Sande, MD, m.vd.sande@nki.nl

    Geerard Beets, MD, PhD

    Recruiting

  • VU Medisch Centrum

    Amsterdam

    Jurriaan Tuynman, MD, PhD

    Not yet recruiting

  • Amphia Ziekenhuis

    Breda

    Rogier Crolla, MD, PhD

    Not yet recruiting

  • Deventer Ziekenhuis

    Deventer

    Koen Talsma, MD, PhD

    Recruiting

  • Westfriesgasthuis

    Hoorn

    Erik Sonneveld, MD, PhD

    Recruiting

  • Leeuwarden Medisch Centrum

    Leeuwarden

    Christiaan Hoff, MD, PhD

    Not yet recruiting

  • Leiden University Medical Center

    Leiden

    Koen Peeters, MD, PhD

    Not yet recruiting

  • Maastricht University Medical Centre

    Maastricht

    Stephanie Breukink, MD, PhD

    Recruiting

  • Radboud UMC

    Nijmegen

    Hans de Wilt, MD, PhD

    Recruiting

  • Elisabeth Tweesteden Ziekenhuis

    Tilburg

    David Zimmerman, MD, PhD

    Not yet recruiting

  • Diakonessenhuis

    Utrecht

    Apollo Pronk, MD, PhD

    Not yet recruiting

  • Universitair Medisch Centrum Utrecht

    Utrecht

    Martijn Intven, MD, PhD

    Not yet recruiting

  • Isala Klinieken

    Zwolle

    Erik van Westreenen, MD, PhD

    Recruiting

Other trials in Netherlands

Belgium1 site, 1 recruiting

  • Universitair Ziekenhuis Antwerpen

    Antwerp

    Niels Koomen, MD, PhD

    Recruiting

Other trials in Belgium

About this study

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

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.

Read the 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.

Keywords
Complete response, Organ preservation, Wait-and-See, Watch-and-Wait, Watchful Waiting
Medical subject headings
Rectal Neoplasms, Pathologic Complete Response

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03426397
Study groupRoleWhat they receive
Study populationNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 2-year non-regrowth disease-free survival

    Absence of non-regrowth local or distant recurrence or death within 2 years of follow-up

    Measured: 2 years after start of wait-and-see protocol

Secondary outcomes (6)

  1. Number of fully operational centres

    Number of operational centres who can deliver high quality organ preserving care in rectal cancer in the Netherlands

    Measured: 2 years after start of wait-and-see protocol

  2. 2-year local regrowth rate

    The proportion of local regrowth

    Measured: 2 years after start of wait-and-see protocol

  3. 2-year local control

    Absence of local recurrence(unresectable regrowth, resected with R1, or requiring more extensive than TME surgery) or death

    Measured: 2 years after start of wait-and-see protocol

  4. 2-year overall survival

    Absence of death

    Measured: 2 years after start of wait-and-see protocol

  5. Determination of the optimal follow-up schedule

    A balance between early detection of recurrence and compliance to follow-up

    Measured: 2 years after start of wait-and-see protocol

  6. Quality of life

    Quality of life (general health, disease specific and functional outcomes)

    Measured: At 3 months, 1 year, 2 years and 5 years after the start of wait-and-see protocol

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2018
  2. Study start10 May 2017
  3. Primary completion1 Jun 2021 (estimated)
  4. Study completion1 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
220 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03426397
Sponsor's protocol ID
M16WAS
Status last verified
Jul 2020
First submitted
21 Dec 2017
Last updated
29 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Meyer 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.

    PubMed 34856587

Questions about this trial

What is this clinical trial studying?

An observational study of Rectal Neoplasms, run by The Netherlands Cancer Institute at 14 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Netherlands, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Marit van der Sande, MD (0031205129111, m.vd.sande@nki.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

2-year non-regrowth disease-free survival (time frame: 2 years after start of wait-and-see protocol). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03426397, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2020.

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