Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

TARSARC : TARGETING ATR IN SOFT-TISSUE SARCOMAS: A RANDOMIZED PHASE II STUDY

This research, called TARSARC, is a Phase II study testing a new treatment for adults with advanced soft-tissue leiomyosarcoma, a type of cancer that affects muscles and other soft tissues. The study is comparing two approaches: one group will receive a new drug called berzosertib alongside the standard chemotherapy drug gemcitabine, while the other group will receive gemcitabine alone. Doctors want to find out if adding berzosertib helps to stop the cancer from growing or spreading for longer. They will closely watch how patients respond over six months by looking at scans, and they will also monitor for any side effects. This study aims to find more effective ways to treat this specific type of cancer.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Institut Bergonie

Enrolment target

Start

12 Mar 2024

Adult patients with locally advanced/unresectable and/or metastatic soft-tissue leiomyosarcomas.

What is this study about?

This study, called TARSARC, is designed to investigate a new treatment approach for a type of cancer known as soft-tissue leiomyosarcoma. This cancer affects muscles and other soft tissues in the body, and this study focuses on cases where the cancer has grown locally and can't be removed with surgery, or has spread to other parts of the body. The main goal is to see if a new drug, berzosertib, when given together with a standard chemotherapy drug called gemcitabine, can be more effective than gemcitabine by itself.

The study will follow participants for six months to see how well the treatments work. Doctors will use scans to measure if the cancer shrinks, stays the same, or grows. This is known as the 'progression-free rate' and helps them understand if the treatment is keeping the cancer under control. By comparing the results from the group getting both drugs to the group getting only gemcitabine, researchers hope to identify a better treatment option for patients.

Beyond simply looking at how the cancer responds, the study will also carefully check for side effects of the treatments. They want to ensure that any new treatment is not only effective but also safe for patients. Furthermore, researchers will collect samples, like blood and tissue, to understand how the drugs work in the body at a tiny level. This kind of research is crucial for developing better and safer cancer treatments in the future.

Key takeaways

Tests a new drug (berzosertib) with standard chemotherapy (gemcitabine).
Aims to find better treatments for advanced soft-tissue leiomyosarcoma.
Compares the new combination against chemotherapy alone.
Focuses on how long the cancer is kept under control (progression-free rate).
Closely monitors safety and side effects of the treatments.
Contributes to understanding the disease and developing future therapies.

Who may be eligible?

To be considered for this study, you must be an adult, aged 18 or older, without an upper age limit. The study is open to both men and women.

Specifically, the study is looking for patients who have been diagnosed with a type of cancer called "soft-tissue leiomyosarcoma." This diagnosis needs to be confirmed. Your cancer must also be considered advanced – meaning it is either locally advanced (has grown in the area but cannot be removed by surgery), or it has spread to other parts of your body.

This study is not suitable for everyone with this type of cancer; there will be other specific medical criteria that your doctor will review to determine if it's the right study for you. These criteria are essential to ensure the study is safe and that results are clear.

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.

Are you 18 years old or older?
Have you been diagnosed with soft-tissue leiomyosarcoma?
Is your leiomyosarcoma considered locally advanced (can't be removed by surgery) or has it spread to other parts of your body?
Are you willing to discuss your overall health with the study doctor to ensure you meet all specific medical requirements?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned to one of two groups. One group will receive the new drug berzosertib along with gemcitabine chemotherapy, and the other group will receive gemcitabine chemotherapy alone. Both drugs are given through an IV drip.

You will have regular hospital visits for your treatment and to have various tests, such as blood tests and scans (like CT or MRI scans). These tests help doctors monitor how well the treatment is working and check for any side effects. These scans are particularly important for understanding if the cancer is shrinking or being kept under control.

The initial part of the study where the main results are measured will last for six months. However, your involvement might continue longer if your treatment is helping. The clinic staff will explain your specific schedule of visits and tests, as well as the total expected duration of your participation.

Potential risks and benefits

Participating in a clinical trial like this may offer potential benefits, such as access to a new treatment (berzosertib) that is not yet widely available and might be more effective than standard treatment. However, there's no guarantee that the treatment will work for everyone, and it's also possible that the combination treatment might not be more effective than gemcitabine alone. There are always potential risks involved with any medication, including potential side effects from both berzosertib and gemcitabine. The study team will carefully monitor you for any side effects and provide appropriate care. You are joining this study voluntarily, and you have the right to withdraw at any time, for any reason, without affecting your future medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is leiomyosarcoma?

Leiomyosarcoma is a rare type of cancer that starts in smooth muscles, which are found in internal organs like the stomach, intestines, and uterus, as well as in the walls of blood vessels.

What does 'Phase II' study mean?

A Phase II study means researchers are testing a new treatment in a larger group of people to see if it's effective for a specific condition and to further evaluate its safety. It comes after early safety tests.

What are gemcitabine and berzosertib?

Gemcitabine is a common chemotherapy drug used to treat various cancers. Berzosertib is a new experimental drug that works differently and is being tested to see if it can improve gemcitabine's effects.

Will I know which treatment I'm getting?

In this study, patients are randomly assigned to one of two treatment groups. Sometimes, to keep the study fair, you might not know which specific treatment you are receiving until after the study is complete, but this will be fully explained before you agree to participate.

What does 'progression-free rate' mean?

This term refers to the percentage of patients in the study whose cancer does not grow or spread for a certain period (in this case, six months). It includes situations where the cancer shrinks or stays the same size.