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Taking people in NetherlandsPhase 2

Testing whether rectal cancer can be treated without removing the rectum

Tests radiotherapy with watchful waiting or surgery in adults with early rectal cancer.

Key facts

Who runs it
Radboud universitair medisch centrum Stichting
Where
Amsterdam, Arnhem, Breda, Capelle aan den IJssel, Deventer, Eindhoven, Groningen, Hoofddorp, Leeuwarden, Leiden, Maastricht, Nijmegen, Rotterdam, Tilburg, Utrecht, and Zwolle, NetherlandsSee the 24 sites
Registry title
Can we Save the rectum by watchful waiting or transanal surgery following short- or long-course radioTherapy and Additional local oR systemic Treatment for early-stage REctal Cancer?
Status
Recruiting
Phase
Phase 2
People taking part
280 people, planned
Started
14 Oct 2024
Expected to end
31 Dec 2032
Type of study
Interventional
Record updated
8 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with early-stage cancer of the middle or lower rectum, to see whether the rectum can be saved without removing it.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Biopsy-proven adenocarcinoma of the rectum. Early or early-intermediate stage on MRI: T1-3ab, N0 or N1 (up to 3 lymph nodes of 8mm or less), M0 or MX. Tumour in the lower or middle rectum, where TME surgery is needed.
Earlier treatment
No earlier local removal of the tumour (endoscopic or surgical). No earlier radiotherapy to the pelvis.

Main reasons for not taking part

  • Other cancer within the last 3 years (with some exceptions)
  • Proven spread to other organs or regions (M1)
  • Pregnant or breastfeeding women
  • Existing faecal incontinence expected to worsen quality of life after treatment
  • MRI signs such as suspicious lymph nodes, vessel invasion, mucinous tumour, or tumour within 1mm of the mesorectal fascia

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • Biopsy proven adenocarcinoma of the rectum
  • Early- or early-intermediate stage rectal cancer, defined as Magnetic Resonance Imaging (MRI)-T1-3ab, N0/N1 (≤3 mesorectal lymph nodes ≤8mm), MX/M0 rectal tumour
  • Tumour located in the distal or mid-rectum for which TME-surgery is required
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Age 18 years or older
  • Patient able and willing to provide written informed consent for the study

Who cannot take part

  • Tumour located in the proximal rectum for which PME-surgery will be sufficient
  • Any form of (endoscopic/surgical) local excision of the primary tumour prior to study-entry
  • Prior pelvic radiotherapy
  • Concomitant or previous malignancies within 3 years prior to trial entry, except those that in the opinion of the MDT are unlikely to relapse < 3 years or lead to death < 5 years
  • Definite evidence of regional or distant metastases (M1) in opinion of MDT
  • Pregnant or lactating women
  • Pre-existing faecal incontinence, leading to an expected impaired quality of life post-treatment
  • MRI suspicious lymph nodes cN1 (1-3 lymph nodes > 8mm) or cN2
  • MRI extramural vascular invasion (mriEMVI) present (defined by protocol guidelines)
  • MRI defined mucinous tumour
  • Mesorectal fascia threatened by tumour (≤ 1mm on MRI)

Where in Netherlands

  • Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis StichtingAmsterdam, NetherlandsTaking people
  • Stichting Amsterdam UMCAmsterdam, NetherlandsTaking people
  • Stichting OLVGAmsterdam, NetherlandsTaking people
  • RadiotherapiegroepArnhem, NetherlandsTaking people
  • Rijnstate Ziekenhuis StichtingArnhem, NetherlandsTaking people
  • Amphia HospitalBreda, NetherlandsTaking people
  • IJsselland ZiekenhuisCapelle aan den IJssel, NetherlandsTaking people
  • Deventer ZiekenhuisDeventer, NetherlandsTaking people
  • Catharina Ziekenhuis StichtingEindhoven, NetherlandsTaking people
  • Stichting Martini ZiekenhuisGroningen, NetherlandsTaking people
  • Universitair Medisch Centrum GroningenGroningen, NetherlandsTaking people
  • Spaarne Gasthuis StichtingHoofddorp, NetherlandsTaking people
  • Medisch Centrum Leeuwarden B.V.Leeuwarden, NetherlandsTaking people
  • Radiotherapeutisch Instituut FrieslandLeeuwarden, NetherlandsTaking people
  • Leids Universitair Medisch Centrum (LUMC)Leiden, NetherlandsTaking people
  • Maastricht University Medical Center+ (MUMC+)Maastricht, NetherlandsTaking people
  • MaastroMaastricht, NetherlandsTaking people
  • Radboud Universitair Medisch Centrum (Radboudumc)Nijmegen, NetherlandsTaking people
  • Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)Rotterdam, NetherlandsTaking people
  • Dr. Bernard Verbeeten Instituut StichtingTilburg, NetherlandsTaking people
  • Stichting Elisabeth-TweeSteden ZiekenhuisTilburg, NetherlandsTaking people
  • Diakonessenhuis StichtingUtrecht, NetherlandsTaking people
  • Universitair Medisch Centrum UtrechtUtrecht, NetherlandsTaking people
  • Isala Klinieken StichtingZwolle, NetherlandsTaking people

About the trial

What the trial wants to find out

The assessment of successful organ preservation rates in the concerning study arms.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
STARTREC - Can we Save the rectum by watchful waiting or transanal surgery following short- or long-course radioTherapy and Additional local oR systemic Treatment for early-stage REctal Cancer?
Plain-language title
Testing whether rectal cancer can be treated without removing the rectumGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
8 October 2026