Actively Recruiting
Hyperthermia With Chemoradiotherapy in Rectal Cancer
Led by University Hospital Tuebingen · Updated on 2025-02-18
264
Participants Needed
2
Research Sites
650 weeks
Total Duration
On this page
Sponsors
U
University Hospital Tuebingen
Lead Sponsor
U
University Hospital Erlangen
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Hyperthermia With Chemoradiotherapy in Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients with histologically confirmed rectal cancer located 0-12 cm from the anocutaneous line
- Indicated for total neoadjuvant therapy
- MRI-staged rectal cancer with high-risk features: cT4, cN2, distance to mesorectal fascia 1mm or less, involved lateral pelvic lymph nodes, or EMVI positivity
- High-resolution pelvic MRI and cross-sectional imaging of abdomen and chest to exclude distant metastases
- Aged 18 years or older, no upper age limit
- WHO/ECOG Performance Status �4 1
- Adequate blood, liver, kidney, and metabolic function
- Informed consent given
You will not qualify if you...
- Tumor lower border more than 12 cm from the anocutaneous line
- Tumors with microsatellite instability (MSI-High) eligible for immune checkpoint therapy
- Contraindications for hyperthermia such as metal implants or pacemakers
- Presence of distant metastases
- Preexisting fecal incontinence for solid stool
- Prior antineoplastic therapy or pelvic radiotherapy for rectal cancer
- Major surgery within 4 weeks before inclusion
- Pregnant, breastfeeding, or planning pregnancy within 6 months after treatment
- Unwillingness to use effective contraception during and 6 months after treatment
- Other concurrent antineoplastic therapies
- Serious concurrent diseases including neurological, psychiatric, infectious, coagulation disorders
- Significant cardiovascular disease within 6 months before enrollment
- Prior or concurrent malignancy within 3 years except some skin or cervical cancers
- Known allergies to study medications
- Known dihydropyrimidine dehydrogenase deficiency
- Psychological, familial, sociological, or geographical conditions hampering study compliance
AI-Screening
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Trial Site Locations
Total: 2 locations
1
University Hospital
Tübingen, Baden-Wurttemberg, Germany, 72076
Actively Recruiting
2
Universitätsklinikum Tübingen
Tübingen, Baden-Wurttemberg, Germany, 72076
Actively Recruiting
Research Team
C
Cihan Gani, MD, Prof. Dr.
CONTACT
B
Barbara Gehler, MD, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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