Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study of Atezolizumab with High Dose Radiation vs. Radiation Alone for Patients with Oligometastatic Soft Tissue Sarcoma

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer known as Soft Tissue Sarcoma, which can occur in various parts of the body. The study is exploring a treatment that combines a medication called Atezolizumab (also known by its code name RO5541267) with a form of high-dose radiation therapy called Stereotactic Body Radiation Therapy (SBRT). Atezolizumab is given as a solution through a vein, a method known as intravenous administration. The trial aims to compare the effects of using Atezolizumab with SBRT against using SBRT alone in patients who have a specific condition called Oligometastatic Sarcomas, which means the cancer has spread to a limited number of other parts of the body.

The purpose of the study is to evaluate how well this combination treatment works in preventing the cancer from getting worse over a period of six months. Participants in the study will be randomly assigned to one of two groups: one group will receive both Atezolizumab and SBRT, while the other group will receive only SBRT. The study will monitor the participants' health and the progression of their cancer over time to determine the effectiveness of the treatment.

Throughout the study, participants will undergo regular check-ups and assessments to track their response to the treatment. The study will also look at various factors such as the overall survival of participants, their quality of life, and any side effects they may experience. The information gathered from this trial will help researchers understand the potential benefits and risks of combining Atezolizumab with SBRT for treating soft tissue sarcomas.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be required to provide written informed consent. This is a formal agreement to participate in the trial after understanding its purpose and procedures.

  2. Step 2

    Initial assessment

    The patient will undergo an initial assessment to confirm eligibility. This includes verifying the diagnosis of soft tissue sarcoma and ensuring the patient meets specific health criteria, such as adequate organ function and performance status.

  3. Step 3

    Randomization

    The patient will be randomly assigned to one of two groups: one receiving atezolizumab with high-dose radiation therapy, and the other receiving only high-dose radiation therapy.

  4. Step 4

    Treatment administration

    For patients in the atezolizumab group, the medication will be administered as a solution for infusion through intravenous administration. The dosage is 1,200 mg, and the frequency and duration will be determined by the study protocol.

    Patients in both groups will receive high-dose radiation therapy, known as stereotactic body radiation therapy (SBRT), targeting the metastatic sarcoma.

  5. Step 5

    Monitoring and follow-up

    Throughout the trial, the patient's health and response to treatment will be closely monitored. This includes regular medical evaluations and imaging tests to assess the progression of the disease.

    The primary goal is to evaluate progression-free survival at 6 months, meaning the length of time during and after treatment that the patient lives with the disease without it getting worse.

  6. Step 6

    Completion of the trial

    Upon completion of the treatment phase, the patient will continue to be monitored for any long-term effects and overall survival. Quality of life assessments will also be conducted to evaluate the impact of the treatment.

Who can join the trial?

12 criteria

  • Must have a confirmed diagnosis of Soft Tissue Sarcoma (a type of cancer that occurs in soft tissues like muscles, fat, and nerves).
  • Women who can have children must have a negative pregnancy test before starting the study and agree to use two methods of birth control or be surgically sterile during the study and for 120 days after the last dose. Men must agree to use contraception during the study and for 120 days after the last dose.
  • Must be willing and able to sign a consent form to participate in the trial.
  • Must have health insurance coverage.
  • Must have a progressive disease according to specific medical criteria (RECIST 1.1), which means the disease is getting worse.
  • Must have metastatic disease, meaning the cancer has spread to other parts of the body, with 1 to 5 visible tumors in the chest or abdomen, and the total size of these tumors should not exceed 10 cm.
  • Must have at least one tumor that can be measured and is less than 5 cm in size for treatment.
  • Must be in the first or second stage of metastatic treatment.
  • Must be 18 years or older at the time of signing the consent form.
  • Must have a performance status of 0 or 1 on the ECOG Performance Scale, which means the patient is fully active or has some symptoms but can carry out light work.
  • Must have adequate organ function, which includes specific blood and kidney function levels that are within normal limits.
  • Surgical removal of tumors is possible if needed before starting a specific radiation treatment (SBRT), but it must be done at least 4 weeks before joining the study, and at least one tumor must be treated with SBRT.

Who cannot join the trial?

3 criteria

  • Patients who are not diagnosed with Soft Tissue Sarcoma cannot participate. Soft Tissue Sarcoma is a type of cancer that starts in the soft tissues of the body, like muscles or fat.
  • Patients who are younger than 18 years old or older than 65 years old cannot participate.
  • Patients who are part of a vulnerable population, such as those who cannot make decisions for themselves, cannot participate.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Atezolizumab

    is a medication used in this trial to help the body's immune system fight cancer. It works by blocking a protein that stops the immune system from attacking cancer cells, allowing the immune system to better target and destroy these cells.

  • High Dose Radiation (SBRT)

    is a type of therapy that uses focused, high doses of radiation to target and kill cancer cells in specific areas of the body. In this trial, it is used to treat patients with oligometastatic sarcomas, either alone or in combination with atezolizumab.

What is already known about the treatment

Atezolizumab – Atezolizumab is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating soft tissue sarcoma. It is an immunotherapy drug that works by blocking a protein called PD-L1, which helps cancer cells evade the immune system. By inhibiting this protein, atezolizumab enables the immune system to better recognize and attack cancer cells. It is classified as a monoclonal antibody and is being evaluated for its potential to improve progression-free survival in patients with oligometastatic sarcomas when used alongside high-dose radiation therapy.

Investigated diseases

Soft Tissue Sarcoma – Soft tissue sarcoma is a type of cancer that begins in the tissues that connect, support, or surround other structures and organs of the body. These tissues include muscles, fat, blood vessels, nerves, tendons, and the lining of the joints. The disease can occur in any part of the body but is most commonly found in the arms, legs, and trunk. It often starts as a painless lump or swelling and may grow slowly or rapidly. As the tumor enlarges, it can press on nerves and muscles, causing pain or discomfort. The progression of soft tissue sarcoma can vary widely depending on the specific type and location of the tumor.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511313-38-00Protocol code2017-004239-35Estimated enrolment103 patientsSponsorCentre Antoine Lacassagne

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.