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Organ Preservation in Rectal Cancer: Contact X-ray Brachytherapy vs Extending the Waiting Interval and Local Excision
Sponsor: The Netherlands Cancer Institute
Summary
The goal of this prospective phase II feasibility study is to evaluate two additional local treatment options in rectal cancer patients with a good clinical response after neoadjuvant (chemo)radiation: contact x-ray brachytherapy versus extension of the waiting interval with or without local excision, and to investigate which rate of organ preservation can be achieved.
Official title: Organ Preservation in Patients With a Good Clinical Response After (Chemo)Radiation for Rectal Cancer: Defining the Role of Additional Contact X-ray Brachytherapy Versus Extending the Waiting Interval and Local Excision
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
168
Start Date
2021-04-16
Completion Date
2029-03
Last Updated
2023-03-17
Healthy Volunteers
No
Interventions
Contact x-ray brachytherapy
With contact x-ray brachytherapy an intraluminal radiation boost up to 90 Gy is applied to the primary rectal tumour, with minimal collateral damage to the surrounding normal tissues due to minimal penetration of the 50 kVolt therapy.
Local excision
Local excision will basically be performed by the TAMIS-procedure (transanal minimally invasive surgery).
Locations (7)
Radbouw University Medical Centre
Nijmegen, Gelderland, Netherlands
Catharina Hospital
Eindhoven, North Brabant, Netherlands
Antoni van Leeuwenhoek
Amsterdam, North Holland, Netherlands
Deventer Hospital
Deventer, Overijssel, Netherlands
Isala
Zwolle, Overijssel, Netherlands
Medical Center Leeuwarden
Leeuwarden, Provincie Friesland, Netherlands
Ijsselland Hospital
Capelle aan den IJssel, South Holland, Netherlands