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?
Key facts
- Where
- Amsterdam, Arnhem, Breda, Capelle aan den IJssel, Deventer, Eindhoven, Groningen, Hoofddorp, Leeuwarden, Leiden, Maastricht, Nijmegen, Rotterdam, Tilburg, Utrecht és Zwolle, HollandiaSee the 24 sites
- Phase
- 2. fázis
Where in Hollandia
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis StichtingAmsterdam, HollandiaTaking people
- Stichting Amsterdam UMCAmsterdam, HollandiaTaking people
- Stichting OLVGAmsterdam, HollandiaTaking people
- RadiotherapiegroepArnhem, HollandiaTaking people
- Rijnstate Ziekenhuis StichtingArnhem, HollandiaTaking people
- Amphia HospitalBreda, HollandiaTaking people
- IJsselland ZiekenhuisCapelle aan den IJssel, HollandiaTaking people
- Deventer ZiekenhuisDeventer, HollandiaTaking people
- Catharina Ziekenhuis StichtingEindhoven, HollandiaTaking people
- Stichting Martini ZiekenhuisGroningen, HollandiaTaking people
- Universitair Medisch Centrum GroningenGroningen, HollandiaTaking people
- Spaarne Gasthuis StichtingHoofddorp, HollandiaTaking people
- Medisch Centrum Leeuwarden B.V.Leeuwarden, HollandiaTaking people
- Radiotherapeutisch Instituut FrieslandLeeuwarden, HollandiaTaking people
- Leids Universitair Medisch Centrum (LUMC)Leiden, HollandiaTaking people
- Maastricht University Medical Center+ (MUMC+)Maastricht, HollandiaTaking people
- MaastroMaastricht, HollandiaTaking people
- Radboud Universitair Medisch Centrum (Radboudumc)Nijmegen, HollandiaTaking people
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)Rotterdam, HollandiaTaking people
- Dr. Bernard Verbeeten Instituut StichtingTilburg, HollandiaTaking people
- Stichting Elisabeth-TweeSteden ZiekenhuisTilburg, HollandiaTaking people
- Diakonessenhuis StichtingUtrecht, HollandiaTaking people
- Universitair Medisch Centrum UtrechtUtrecht, HollandiaTaking people
- Isala Klinieken StichtingZwolle, HollandiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Radboud universitair medisch centrum Stichting
- Trial code
- EU 2024-514620-17-00
- Record updated
- 2026. október 8.
- Original description
The assessment of successful organ preservation rates in the concerning study arms.Read full original descriptionShow less
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?
The assessment of successful organ preservation rates in the concerning study arms.
Inclusion: 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.
Exclusion: 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).