Using heat therapy with chemotherapy and radiation for rectal cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of deep regional hyperthermia combined with radiochemotherapy followed by consolidation chemotherapy in patients with locally advanced rectal cancer. Participants will be randomly assigned to receive either standard treatment or treatment with the addition of hyperthermia. The study aims to determine if this approach can lead to complete tumor regression, potentially allowing some patients to avoid surgery. Key outcomes include tumor downstaging, quality of life assessments, and rates of sphincter-sparing surgeries.

Why it matters

Who can join: the full rules

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)

Where it's running

• University Hospital
  Tübingen, Baden-Wurttemberg, Germany Recruiting
• Universitätsklinikum Tübingen
  Tübingen, Baden-Wurttemberg, Germany Recruiting

Study contacts

• Principal investigator: Cihan Gani, MD, Prof. Dr. — University Hospital Tuebingen
• Study coordinator: Cihan Gani, MD, Prof. Dr.
• Email: cihan.gani@med.uni-tuebingen.de
• Phone: +49 7071 29-82165

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.