AzTrials
AzTrials

Rectal CancerNCT05539417

Snapshot Rectumcarcinoom 2016

An observational study of Rectal Cancer, run by Amsterdam UMC, location VUmc.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The treatment of rectal cancer is developing rapidly in the Netherlands, as well as internationally. This is accompanied by an increase in complexity of diagnosis and treatment, particularly when the tumor is located closer to the anorectal junction. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rectal Cancer
How many people
3,107 participants
Where
No sites listed yet
Study dates
1 Jan 2016to 31 Dec 2016
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: All patients who underwent resection for primary rectal cancer in the Netherlands in 2016.

Who may be able to join

  • Primary rectal cancer
  • Operated in 2016 in a Dutch hospital
  • Registred in the DCRA-register

Who cannot join

  • Wait and see
  • Resection for regrowth after wait and see

About this study

The treatment of rectal cancer is developing rapidly in the Netherlands, as well as internationally. This is accompanied by an increase in complexity of diagnosis and treatment, particularly when the tumor is located closer to the anorectal junction. Within these developments there is an important role for quality evaluation, where continuous feedback is able to improve care for rectal cancer in the Netherlands. By supplementing data from the Dutch ColoRectal Audit (DCRA) with additional data concerning diagnostics and treatment of rectal cancer patients operated in the year 2016, the Snapshot Rectumcarcinoom 2016 aimed to assess the improvement in surgical and oncological outcomes.

Read the detailed description

Multiple changes in the treatment pathway for rectal cancer patients have contributed to the rapid developments over the last decade. First of all, in 2014 there has been revision of the guidelines, which adjusted MRI assessment and changed indications for neoadjuvant treatment. Moreover, the start of population screening has led to earlier detection of rectal cancer, which has increased attention for organ-sparing treatment. Furthermore, there has been a shift in surgical treatment towards more minimally invasive surgery and new techniques including robotic surgery and TaTME have been introduced. The centralization of care for rectal cancer patients has led to a decrease in number of hospitals that provide this care. These changes together ask for quality evaluation to provide feedback for further improvement of rectal cancer care in the Netherlands.

The Snapshot Rectumcarcinoom has been conducted retrospectively in 2021 concerning the patients operated in 2016 with a 4 year follow up. A similar snapshot study to evaluate outcomes of patients with rectal cancer who were operated in 2011 has been conducted retrospectively in 2015. This enables the Snapshot Rectumcarcinoom 2016 study to compare the oncological and surgical outcomes between 2011 and 2016.

Moreover, this study aimed to evaluate the practices and treatment of patients rectal cancer and enlarged lateral lymph nodes in 2016. Since the implementation of TME surgery there has been a shift toward more lateral recurrences, most likely caused by inadequate treatment of lateral lymph nodes. An international guideline for the appropriate treatment has been lacking, causing substantial variation practices. For example, lateral lymph nodes are often not mentioned by radiologists or during multidisciplinary meetings and there is no clear consensus concerning delineation of radiotherapy in lateral nodes. Moreover, in contrast to Asian countries, in the Netherlands surgical resection of the lateral lymphatic tissue is almost never done as clinicians have always relied on neoadjuvant treatment to sterilize the lateral compartment. Nevertheless, the Consortium study found that 16% of the population of rectal cancer patients had enlarged lateral lymph nodes, leading to a 19.5% 5-year lateral recurrence rate. When these nodes were removed by lateral lymph node dissection (LLND), this recurrence percentage was reduced to 5.7%. The Snapshot study aimed assess the current heterogeneity in diagnostics and treatment of lateral lymph nodes and increase awareness by training of the different specialties.

Conditions
Rectal Cancer
Medical subject headings
Rectal Neoplasms

What is being measured

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

  1. How do different variables affect oncological and surgical outcomes?

    This study will evaluate development between 2011 and 2016 by comparing this cohort to the Snapshot 2011 study.

    Measured: 2016-2020

  2. The variation in treatment and awareness of lateral lymph nodes in patients with rectal cancer.

    This study aims to assess the variation in treatment and the awareness of lateral lymph nodes in patients with rectal cancer. To increase awareness and improve current practices, MRI reassessment after training of radiologists will take place. Moreover, delineation training will be given to radiation oncologists. After these improvements in current practice, evaluation of this training will take place.

    Measured: 2016-2020

Secondary outcomes (3)

  1. Anastomotic leakage

    Percentage of anastomotic leakage

    Measured: 2016-2020

  2. Permanent stoma rate

    Permanent stoma rate

    Measured: 2016-2020

  3. Presence of presacral abscess

    Presence of presacral abscess

    Measured: 2016-2020

Timeline

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

  1. First posted14 Sep 2022
  2. Study start1 Jan 2016
  3. Primary completion31 Dec 2016
  4. Study completion31 Dec 2016

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
Retrospective
Enrolment
3,107 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05539417
Sponsor's protocol ID
2020.366
Status last verified
Sep 2022
First submitted
9 Sep 2022
Last updated
16 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD data that underlie results in a publication can be made available upon reasonable request

Publications

  • Ogura A, Konishi T, Cunningham C, Garcia-Aguilar J, Iversen H, Toda S, Lee IK, Lee HX, Uehara K, Lee P, Putter H, van de Velde CJH, Beets GL, Rutten HJT, Kusters M; Lateral Node Study Consortium. Neoadjuvant (Chemo)radiotherapy With Total Mesorectal Excision Only Is Not Sufficient to Prevent Lateral Local Recurrence in Enlarged Nodes: Results of the Multicenter Lateral Node Study of Patients With Low cT3/4 Rectal Cancer. J Clin Oncol. 2019 Jan 1;37(1):33-43. doi: 10.1200/JCO.18.00032. Epub 2018 Nov 7.

    PubMed 30403572

  • Ogura A, Konishi T, Beets GL, Cunningham C, Garcia-Aguilar J, Iversen H, Toda S, Lee IK, Lee HX, Uehara K, Lee P, Putter H, van de Velde CJH, Rutten HJT, Tuynman JB, Kusters M; Lateral Node Study Consortium. Lateral Nodal Features on Restaging Magnetic Resonance Imaging Associated With Lateral Local Recurrence in Low Rectal Cancer After Neoadjuvant Chemoradiotherapy or Radiotherapy. JAMA Surg. 2019 Sep 1;154(9):e192172. doi: 10.1001/jamasurg.2019.2172. Epub 2019 Sep 18.

    PubMed 31268504

  • van Geffen EGM, Verheij FS, Hazen SMJA, Sluckin TC, Consten ECJ, Dekker JT, Nederend J, Peeters KCMJ, de Wilt JHW, van Dieren S, Hompes R, Tuynman JB, Marijnen CAM, Tanis PJ, Kusters M; Dutch Snapshot Research Group. Oncological outcomes of planned and unplanned low Hartmann's procedure and restorative low anterior resection for rectal cancer: a population-based cross-sectional study. Tech Coloproctol. 2025 Nov 23;30(1):4. doi: 10.1007/s10151-025-03169-5.

    PubMed 41276685

  • Moolenaar LR, van Geffen EGM, Hazen SJA, Sluckin TC, Beets GL, Leijtens JWA, Talsma AK, de Wilt JHW, Tanis PJ, Kusters M, Hompes R, Tuynman JB; Dutch Snapshot Research Group; Collaborators Snapshot Registry. Salvageable locoregional recurrence and stoma rate after local excision of pT1-2 rectal cancer - A nationwide cross-sectional cohort study. Eur J Surg Oncol. 2025 Jun;51(6):109623. doi: 10.1016/j.ejso.2025.109623. Epub 2025 Jan 23.

    PubMed 40009914

  • Geffen EGMV, Nederend J, Sluckin TC, Hazen SJA, Horsthuis K, Beets-Tan RGH, Marijnen CAM, Tanis PJ, Kusters M; Dutch Snapshot Research Group. Prognostic significance of MRI-detected extramural venous invasion according to grade and response to neo-adjuvant treatment in locally advanced rectal cancer A national cohort study after radiologic training and reassessment. Eur J Surg Oncol. 2024 Jun;50(6):108307. doi: 10.1016/j.ejso.2024.108307. Epub 2024 Mar 29.

    PubMed 38581757

  • Sluckin TC, Hazen SJA, Horsthuis K, Beets-Tan RGH, Antonisse IE, Berbee M, van Bockel LW, Boer AH, Ceha HM, Cnossen JS, Geijsen ED, den Hartogh MD, Hendriksen EM, Intven MPW, Leseman-Hoogenboom MM, Meijnen P, Muller K, Oppedijk V, Rozema T, Rutten H, Spruit PH, Stam TC, Velema LA, Verrijssen AE, Vos-Westerman J, Tanis PJ, Marijnen CAM, Kusters M; Dutch Snapshot Research Group. Coverage of Lateral Lymph Nodes in Rectal Cancer Patients with Routine Radiation Therapy Practice and Associated Locoregional Recurrence Rates. Int J Radiat Oncol Biol Phys. 2023 Oct 1;117(2):422-433. doi: 10.1016/j.ijrobp.2023.04.013. Epub 2023 Apr 28.

    PubMed 37120027

Questions about this trial

What is this clinical trial studying?

An observational study of Rectal Cancer, run by Amsterdam UMC, location VUmc.

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 3 inclusion and 2 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: finished, as of the sponsor's last update on 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

How do different variables affect oncological and surgical outcomes? (time frame: 2016-2020). The study lists 2 primary outcomes in all. 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 NCT05539417, which also lists 6 linked publications.

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 16 Sep 2022.

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