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

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What is this study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Oncopole Claudius Regaud	Toulouse	France
Centr Georges Francois Leclerc	Dijon	France
Institut De Cancerologie De Lorraine	Vandoeuvre Les Nancy	France

Other Sites

Site Name	City	Country
Centre Antoine Lacassagne	Nice	France
Hopitaux Universitaires Pitie Salpetriere	Paris	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Institut Des Neurosciences De La Timone	Marseille	France
Institut De Cancerologie Strasbourg Europe	STRASBOURG, Alsace	France
Centre Henri Becquerel	Rouen	France
Centre Francois Baclesse	Caen	France
Centre De Lutte Contre Le Cancer Eugene Marquis	Rennes	France
Iltxzqtb Rxvzpubs Dz Czaifk Du Mfdyfwfgxtm	Montpellier	France
Cmsonx Ldjo Bkdeuw	Lyon	France
Icpuowac Bivhiyvl	Bordeaux	France
Ibrjwhjn Pmwdggfhuxgprbq Clebkw Chbjtn	Marseille	France
Cynnzh Opmoe Lhsvumb	Lille	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	04.08.2020

Trial locations

Investigated drugs:

Atezolizumab

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.

Investigated diseases:

Soft tissue sarcoma

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 ID:

2024-511313-38-00

Protocol code:

2017-004239-35

NCT ID:

NCT03548428

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?