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Hyperthermia With Chemoradiotherapy in Rectal Cancer

NCT06831981 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2025-02-18

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • University Hospital Erlangen

    collaborator OTHER

  • Charite University, Berlin, Germany

    collaborator OTHER

  • University Hospital Tuebingen

    lead OTHER

Principal Investigators

  • Cihan Gani, MD, Prof. Dr. · University Hospital Tuebingen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-11
Primary Completion
2036-06-01
Completion
2037-03-01

Countries

  • Germany

Study Locations

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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 NCT06831981 on ClinicalTrials.gov