Not yet recruitingPHASE2INTERVENTIONAL

Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors

This study is investigating a new way to treat certain cancers that have returned in the same area after a patient has already had radiation therapy. It combines a special heat treatment, called hyperthermia, with a second course of radiation, sometimes along with chemotherapy. The conditions include prostate, cervical, anal, and rectal cancers, among others. Researchers want to see if adding heat treatment helps the radiation work better, aiming to control the cancer without causing more side effects than the initial treatment. This study is for people whose cancer has come back in a limited way and where the area can be treated with heat. It's a Phase 2 study, meaning it's exploring the effectiveness and safety of this new approach.

At a glance

Status

Not yet recruiting

Phase

PHASE2

Sponsor

Charite University, Berlin, Germany

Enrolment target

110

Start

10 May 2024

Estimated completion

01 Jan 2028

Recurrent Cancer Prostate Cancer Cervical Cancer Anal Cancer Sarcoma Rectal Cancer Neuroendocrine Tumors Esophageal Cancer Pancreas Cancer Squamous Cell Carcinoma

What is this study about?

When cancer comes back in the same area after a patient has already had radiation treatment, it can be very challenging to treat. This study is exploring a new way to tackle this by combining a special heat treatment, called hyperthermia, with a second course of radiation therapy. Hyperthermia involves gently heating the body part where the cancer is located. Scientists believe that heating the area can make cancer cells more sensitive to radiation, potentially making the treatment more effective.

This research is a Phase 2 study, which means it’s designed to learn more about how well this combined approach works and if it's safe. It's a way for doctors to explore new and potentially better treatments for people facing recurrent cancer. The study focuses on several types of cancer including prostate, cervical, anal, rectal cancers, sarcomas, and some others, providing hope for people whose cancer has returned in a limited area.

The main goal of the study is to see if adding hyperthermia to repeat radiation therapy works at least as well as the original radiation treatment did in controlling the cancer locally. This is measured by how long it takes for the cancer to come back or grow in that area. Researchers will carefully monitor patients throughout the study to understand the benefits and any potential side effects of this combined treatment.

Key takeaways

Targets specific cancers that have returned after initial radiation.
Combines special heat treatment (hyperthermia) with repeat radiation.
Aims to make repeat radiation more effective.
It's a Phase 2 study, checking effectiveness and safety.
Participation includes standard radiation therapy plus hyperthermia sessions.
Voluntary participation; you can withdraw at any time.

Who may be eligible?

To be considered for this study, you would generally need to have had radiation therapy for your cancer before, and your cancer must have come back in the same area or in a limited number of other spots. The area where your cancer has returned must also be suitable for the special heat treatment (hyperthermia), such as parts of your abdomen, pelvis, or limbs. Doctors will also check that you're well enough to undergo the treatments planned in the study.

There are also reasons why you might not be able to join. For example, if you have too many cancer spots, if your cancer has spread to your brain, or if the area where the cancer returned can't be treated with hyperthermia (like your lungs or liver). Also, if you have serious heart problems, a pacemaker, or other large implants in the treatment area, or certain mental health conditions, you might not be eligible. If other, simpler radiation treatments could be used, this study might not be the best option for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Have I had radiation therapy for my cancer before?
Has my cancer come back in a limited area where I previously had radiation?
Is the area where the cancer returned suitable for heat treatment (e.g., not my lungs or liver)?
Do I have a maximum of three cancer spots that have returned?
Do I have any serious heart conditions or a pacemaker in the treatment area?
Am I at least 18 years old?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive repeat radiation therapy, as your doctors would normally recommend, but you will also have the special heat treatment called hyperthermia. Depending on the cancer's location, the heat treatment will be applied using special equipment that uses either microwaves or other heating methods. The exact number of sessions and how long each lasts will depend on your specific situation.

You will have regular appointments with the study team to monitor your health, check how the treatment is working, and manage any side effects. This might include scans, blood tests, and physical examinations. The total duration of your participation will involve the treatment period and then follow-up appointments to track your progress over time.

Potential risks and benefits

Participating in this study might offer the potential benefit of a more effective treatment for your recurrent cancer, if the combination of heat and re-radiation works better than re-radiation alone. However, as with any medical treatment, there are potential risks and side effects from both the radiation therapy and the hyperthermia. Doctors will explain these to you in detail. You are always free to ask questions and discuss any concerns you have. Remember, joining a clinical trial is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Klinik für Radioonkologie und Strahlentherapie
Verified postcode
Berlin, Germany

Common questions

What is hyperthermia?

Hyperthermia is a treatment that uses heat to warm up the area where your cancer is. Doctors believe this can make cancer cells more sensitive to radiation, helping the treatment work better.

What types of cancer is this study for?

This study is for several types of cancer that have come back after previous radiation, including prostate, cervical, anal, rectal, and certain other cancers like some sarcomas.

Will I still get regular cancer treatment?

Yes, you will still receive a second course of radiation therapy according to standard medical guidelines, with the hyperthermia being an added part of the study.

Is this a new treatment?

Combining hyperthermia with radiation is being studied to see how effective it is for cancer that has returned after previous radiation. This particular study is in an earlier stage, called Phase 2.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, for any reason. Your decision will not affect your future medical care.

How to find out more

Sebastian Zschaeck, MD

sebastian.zschaeck@charite.de +4930450650764 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.