RecruitingNot ApplicableNCT06831981

Hyperthermia With Chemoradiotherapy in Rectal Cancer

Radiochemotherapy With Concomitant Deep Regional Hyperthermia in Locally Advanced Rectal Cancer. A Prospective, Randomized Phase III Trial.


Sponsor

University Hospital Tuebingen

Enrollment

264 participants

Start Date

Sep 11, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to evaluate the efficacy of deep regional hyperthermia in the context of radiochemotherapy followed by consolidation chemotherapy in locally advanced rectal cancer. Questions it aims to answer are: * Can surgery be avoided if the tumor completely regresses? * How high is the Local re-growth rate * Is the treatment safe? * Assessment of the Quality of life * Rate of sphincter-sparing surgery * Pathological staging, tumor downstaging * Assessment of continence during the course of therapy Participants will: Undergo radiochemotherapy with or without addition of hyperthermia (50:50 randomisation) followed by standard consolidation chemotherapy. After treatment response evaluation surgery or non-operative management takes place.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether adding hyperthermia (controlled heat applied to the tumor area) to standard combined chemotherapy and radiation treatment (chemoradiotherapy) improves outcomes in patients with high-risk rectal cancer. Heating tumors can make cancer cells more vulnerable to radiation and chemotherapy. **You may be eligible if...** - You have been diagnosed with rectal cancer confirmed by biopsy, located in the lower or middle part of the rectum - Your cancer has high-risk features on MRI (such as invading nearby structures, spreading to many lymph nodes, or invading nearby blood vessels) - You have been recommended for total neoadjuvant therapy (treatment before surgery) - You are at least 18 years old - You have had appropriate staging scans (pelvic MRI and body CT) **You may NOT be eligible if...** - Your cancer does not have high-risk features - You have distant metastases (cancer spread to other organs) - You cannot undergo the required staging procedures 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

OTHERHyperthermia

Additional hyperthermia to radiochemotherapy regime in Arm 1 and radiochemotherapy without additional hyperthermia in Arm 2.

RADIATIONRadiotherapy

Radiotherapy of the pelvis

DRUGChemotherapy with 5-fluorouracil

Chemotherapy with 5-flurouracil is given in parallel to radiotherapy

DRUGConsolidation chemotherapy with FOLFOX

Consolidation chemotherapy with 5-fluorouracil and oxaliplatin


Locations(2)

University Hospital

Tübingen, Baden-Wurttemberg, Germany

Universitätsklinikum Tübingen

Tübingen, Baden-Wurttemberg, Germany

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NCT06831981


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