Hyperthermia With Chemoradiotherapy in Rectal Cancer
Radiochemotherapy With Concomitant Deep Regional Hyperthermia in Locally Advanced Rectal Cancer. A Prospective, Randomized Phase III Trial.
University Hospital Tuebingen
264 participants
Sep 11, 2024
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
Plain Language Summary
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Interventions
Additional hyperthermia to radiochemotherapy regime in Arm 1 and radiochemotherapy without additional hyperthermia in Arm 2.
Radiotherapy of the pelvis
Chemotherapy with 5-flurouracil is given in parallel to radiotherapy
Consolidation chemotherapy with 5-fluorouracil and oxaliplatin
Locations(2)
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NCT06831981