NCT06831981

Hyperthermia With Chemoradiotherapy in Rectal Cancer

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 264 (estimated)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In this prospective, randomized phase III trial "Radiochemotherapy with concomitant deep regional hyperthermia in locally advanced rectal cancer" trial it is hypothesized that with the addition of hyperthermia complete response rates can be further increased resulting in a higher number of patients who can omit surgery in favor of organ preservation and a surveillance protocol. Patients receive radiochemotherapy with 5-FU or capecitabine followed by standard consolidation chemotherapy with 5-FU/folinic acid/oxaliplatin or CAPOX. Hyperthermia will take place based on a 1:1 randomisation. After evaluation of treatment response in week 22 patients will either undergo surgical resection in case of residual tumor or non-operative management when a clinical complete response is seen or repeat evaluation after another 3 months in case of a near clinical complete response. In selected cases endoscopic procedures can be considered as an alternative to radical surgery.The primary objective of the study is to evaluate the efficacy of deep regional hyperthermia in the context of radiochemotherapy followed by consolidation chemotherapy in locally advanced rectal cancer. As the primary endpoint TME-free survival will be used (TMEFS).

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
OTHER	Hyperthermia	Additional hyperthermia to radiochemotherapy regime in Arm 1 and radiochemotherapy without additional hyperthermia in Arm 2.
RADIATION	Radiotherapy	Radiotherapy of the pelvis
DRUG	Chemotherapy with 5-fluorouracil	Chemotherapy with 5-flurouracil is given in parallel to radiotherapy
DRUG	Consolidation chemotherapy with FOLFOX	Consolidation chemotherapy with 5-fluorouracil and oxaliplatin

Timeline

• Start date: 2024-09-11
• Primary completion: 2036-06-01
• Completion: 2037-03-01
• First posted: 2025-02-18
• Last updated: 2025-02-18

Locations

2 sites across 1 country: Germany