Hyperthermia With Chemoradiotherapy in Rectal Cancer

To join this study, you would need to have bowel cancer located in your rectum, specifically between 0 and 12 cm from your anal opening. Your doctor would have already decided that you need a stronger type of treatment (called total neoadjuvant therapy) because your cancer has certain features, like being larger or involving nearby lymph nodes. You must be at least 18 years old, and there's no upper age limit.

Before you can join, doctors will do detailed scans like an MRI of your pelvis and CT scans of your tummy and chest to make sure the cancer hasn't spread to other parts of your body. You should also be generally well enough to take part, meaning you can manage most daily activities without much trouble, and your blood, liver, and kidney test results are within a healthy range.

However, you wouldn't be able to join if your tumour is located more than 12 cm from the anal opening, or if you have specific types of bowel cancer (MSI-High Tumors) that are usually treated with different medications. You also can't have metal implants or a pacemaker (as these can be affected by hyperthermia), or if the cancer has already spread to distant parts of your body. If you have severe bowel control issues, have had previous pelvic radiotherapy, or major surgery recently, you also wouldn't be able to participate. Pregnant or breastfeeding women, or those planning pregnancy, are also not eligible, and participants must agree to use effective contraception.

If you decide to take part in this study, you will first undergo a series of tests to confirm your eligibility. Once enrolled, you will be randomly assigned by chance, much like a coin toss (50/50 chance), to one of two groups. One group will receive standard radiotherapy and chemotherapy (using either 5-fluorouracil or capecitabine). The other group will receive the same standard radiotherapy and chemotherapy, PLUS the special heat treatment called hyperthermia.

After this initial treatment phase, both groups will then receive another round of standard chemotherapy (FOLFOX or CAPOX), which is called 'consolidation chemotherapy'. After all treatments are completed, usually around week 22, doctors will carefully check how much the tumour has shrunk using scans. Depending on the results, you might either have surgery to remove any remaining cancer, or, if the tumour has completely disappeared, you might be managed without surgery through close monitoring. If there's still some tumour but it's very small, doctors might re-evaluate after another three months. The total duration of active treatment and initial follow-up for response evaluation is several months.