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

NCT05772923 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2023-03-17

No results posted yet for this study

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.

Conditions

  • Organ Preservation
  • Rectal Cancer
  • Quality of Life
  • Locally Advanced Rectal Carcinoma

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).

Sponsors & Collaborators

  • Catharina Ziekenhuis Eindhoven

    collaborator OTHER

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • The Netherlands Cancer Institute

    lead OTHER

Principal Investigators

  • Brechtje A Grotenhuis, MD, PhD · Antoni van Leeuwenhoek Hospital

  • Pim Burger, MD, PhD · Catharina Ziekenhuis Eindhoven

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-16
Primary Completion
2025-03-31
Completion
2029-03-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05772923 on ClinicalTrials.gov