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Clinical Trials in Germany / NCT06831981
Recruiting Not applicable

Hyperthermia With Chemoradiotherapy in Rectal Cancer

NCT06831981 · tracked via the Priya Life Science Germany tracker
Phase
Not applicable
Started
2024-09-11
Last updated
2025-02-18

Condition(s) studied

Rectal Cancer

Investigational drug(s) / intervention(s)

HyperthermiaRadiotherapyChemotherapy with 5-fluorouracilConsolidation chemotherapy with FOLFOX

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

Radiotherapy: Radiotherapy of the pelvis

Chemotherapy with 5-fluorouracil: Chemotherapy with 5-flurouracil is given in parallel to radiotherapy

Consolidation chemotherapy with FOLFOX: Consolidation chemotherapy with 5-fluorouracil and oxaliplatin

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Male and female patients with histologically confirmed diagnosis of rectal cancer localized 0-12 cm from the anocutaneous line (i.e. lower and middle third of the rectum) * Indication for total neoadjuvant therapy irrespective of participation in the current study. * Any MRI staged rectal cancer with one of the following high-risk features: * cT4 * cN2 (see Appendix) * Distance to mesorectal fascia 1mm or less. * Involved Lateral pelvic lymph nodes * EMVI (extramural venous invasion) positivity * Staging requirements: High-resolution, thin-sliced (i.e. 3mm) magnetic resonance imaging (MRI) of the pelvis is the mandatory local staging procedure. * Cross-sectional imaging of the abdomen and chest to exclude distant metastases. * Aged at least 18 years. No upper age limit. * WHO/ECOG Performance Status ≤ 1 * Adequate hematological, hepatic, renal and metabolic function parameters * Informed consent of the patient Exclusion Criteria: * Lower border of the tumor localised more than 12 cm from the anocutaneous line as measured by rigid rectoscopy * Tumors with microsatellite instability ("MSI-High Tumors") and the possibility for treatment with immune checkpoint inhibition. * Contraindication for hyperthermia such as metal implants or pacemakers * Distant metastases (to be excluded by CT scan of the thorax and abdomen) * Preexisting fecal incontinence for solid stool * Prior antineoplastic therapy for rectal cancer * Prior radiotherapy of the pelvic region * Major surgery within the last 4 weeks prior to inclusion * Subject pregnant or breastfeeding, or planning to become pregnant within 6 months after the end of treatment * Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment (adequate: oral contraceptives, intrauterine device or barrier method in conjunction with spermicidal jelly) * Other concomitant antineoplastic therapy * Serious concurrent diseases, including neurologic or psychiatric disorders (incl. dementia and uncontrolled seizures), active, uncontrolled infections, active, disseminated coagulation disorder * Clinically significant cardiovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 6 months before enrolment * Prior or concurrent malignancy ≤ 3 years prior to enrolment in study (Exception: non-melanoma skin cancer or cervical carcinoma FIGO stage 0-1), if the patient is continuously disease-free * Known allergic reactions on study medication * Known dihydropyrimidine dehydrogenase deficiency * Psychological, familial, sociological or geographical conditions potentially hampering compliance with the study protocol and follow-up schedule (these conditions should be discussed with the patient before registration in the trial)

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
University Hospital Tübingen Baden-Wurttemberg Recruiting
Universitätsklinikum Tübingen Tübingen Baden-Wurttemberg Recruiting

More University Hospital Tuebingen trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06831981 on ClinicalTrials.gov ↗ ← All trials in Germany