RecruitingNot ApplicableNCT05772923

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

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


Sponsor

The Netherlands Cancer Institute

Enrollment

168 participants

Start Date

Apr 16, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two approaches for people with rectal cancer who respond well to radiation therapy — looking at whether the cancer can be treated without removing the rectum (called organ preservation). One approach uses a focused X-ray treatment directly on the tumor (contact X-ray brachytherapy); the other extends the waiting period after standard radiation before doing a smaller surgery to remove just the tumor. **You may be eligible if...** - You have confirmed rectal cancer (adenocarcinoma) that is within 10 cm of the anal opening - You received short-course or long-course radiation (chemoradiation) as part of your treatment plan - Your tumor shows signs of responding to radiation - You are being evaluated for possible organ-preserving treatment **You may NOT be eligible if...** - Your cancer has spread to distant organs - You are not a candidate for organ preservation based on your tumor's characteristics - You have certain health conditions that make local treatments unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONContact 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.

PROCEDURELocal 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

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NCT05772923


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