Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05772923
NA

Organ Preservation in Rectal Cancer: Contact X-ray Brachytherapy vs Extending the Waiting Interval and Local Excision

Sponsor: The Netherlands Cancer Institute

View on ClinicalTrials.gov

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

RADIATION

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.

PROCEDURE

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