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