Study of Atezolizumab Combined with Radiotherapy in Patients with Operable Soft Tissue Sarcomas

2 1 1 1

What is this study about?

This clinical trial focuses on patients with soft tissue sarcoma, which is a type of cancer that develops in soft tissues like muscles, tendons, and fat. The study examines the effectiveness of combining radiotherapy with atezolizumab (also known as Tecentriq), a medication that helps the immune system fight cancer cells. The purpose is to evaluate how well this combination treatment works compared to using radiotherapy alone in patients who can undergo surgery.

The treatment involves receiving atezolizumab through an intravenous infusion. Patients will receive up to 1200 mg of the medication per day, with treatment lasting up to 12 months. Some patients will receive only radiotherapy, while others will receive both radiotherapy and atezolizumab. After the treatment period, all patients will undergo surgery to remove the tumor.

The study will look at how much of the tumor is destroyed by examining the tissue removed during surgery. Doctors will also monitor how the immune system responds to the treatment by studying various types of immune cells in the tumor tissue. Throughout the study, patients will have regular check-ups to monitor their health and any side effects from the treatment.

1 Initial assessment

Medical tests will be performed to check your eligibility, including blood tests to assess bone marrow, kidney, and liver function

A tumor biopsy will be taken to confirm the diagnosis of soft tissue sarcoma

The tumor must be at least 10 mm in diameter and suitable for biopsy

2 Treatment assignment

You will be randomly assigned to one of the treatment groups

The study compares radiotherapy alone versus radiotherapy with immunotherapy or immunotherapy alone

3 Treatment period

If assigned to the immunotherapy group, you will receive Tecentriq (atezolizumab) through an IV infusion

Radiotherapy will be administered according to the treatment plan if you are in a radiotherapy group

Regular monitoring of your condition and any side effects will be conducted

4 Surgery

After completing the assigned treatment, surgery will be performed to remove the tumor

The removed tissue will be examined to measure the response to treatment

The main measure of success is achieving at least 80% tumor death in the removed tissue

5 Follow-up period

Your recovery will be monitored after surgery

Regular check-ups will continue for at least one year after surgery

The medical team will track any possible return of the cancer and your overall health status

Who Can Join the Study?

Age 18 years or older
Diagnosed with soft tissue sarcoma (a type of tumor that develops in soft tissues), including specific types such as liposarcoma, leiomyosarcoma, myxofibrosarcoma, and others, except for Ewing sarcoma, rhabdomyosarcoma, and myxoid liposarcoma
Tumor must be suitable for radiation therapy before surgery and can be surgically removed with the goal of cure
Must have at least one tumor measuring 10 mm or larger that can be safely biopsied
ECOG performance status of 0 or 1 (able to perform daily activities with minimal assistance)
Adequate blood test results showing:
- Sufficient red blood cells (hemoglobin ≥ 9.0 g/dL)
- Adequate white blood cells and platelets
- Normal kidney function
- Normal liver function
- Normal blood clotting
Must not have received certain treatments within specific timeframes:
- No immune-suppressing medications within 28 days
- No live vaccines within 30 days
- No major surgery within 14 days
- No cancer treatments within 21 days
Women who can become pregnant must have a negative pregnancy test and use effective birth control during the study and for 5 months after
Men who can father children must use effective birth control during the study and for 5 months after
Must be willing to sign informed consent and follow study procedures
Must have medical insurance where applicable

Who Cannot Join the Study?

Age under 18 years old or over 65 years old
Pregnant or breastfeeding women
Previous treatment with radiotherapy in the area to be treated
Presence of metastatic disease (cancer that has spread to other parts of the body)
Active autoimmune disease requiring systemic treatment
Uncontrolled heart, lung, kidney, or liver disease
Known infection with HIV, Hepatitis B, or Hepatitis C
History of other cancer within the last 5 years (except adequately treated non-melanoma skin cancer)
Inability to undergo MRI scanning (such as having metal implants or claustrophobia)
Psychological, family, social, or geographical conditions that could interfere with study participation
Participation in another clinical trial within the last 30 days
Known allergy or hypersensitivity to study medications
Use of systemic corticosteroids (medications that reduce inflammation) or other immunosuppressive medications
Active or chronic infection requiring treatment

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Institut Gustave Roussy	Villejuif	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Cmvhku Lygc Bvzhzg	Lyon	France
Ijvukxbn Pzfghziluraakgj Cucran Cxtilm	Marseille	France
Cswedj Opbys Lrzrxbk	Lille	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	30.07.2018

Trial locations

Investigated drugs:

Atezolizumab

Atezolizumab is a type of immunotherapy medication that works by targeting a protein called PD-L1 on cancer cells. It helps the body’s immune system recognize and fight cancer cells. This medication belongs to a group of drugs called immune checkpoint inhibitors. It is given through an intravenous infusion (through a vein).

Radiotherapy is a type of cancer treatment that uses high-energy radiation beams to target and destroy cancer cells. It is a local treatment, meaning it affects only the specific area of the body where the cancer is located. In this trial, it is used to treat soft tissue sarcomas, which are cancers that develop in soft tissues like muscles, tendons, and fat.

Investigated diseases:

Sarcoma

Soft Tissue Sarcoma – A rare type of cancer that develops in soft tissues of the body, including muscles, tendons, fat, blood vessels, and nerves. The condition typically begins as a painless lump that grows over time. Localized soft tissue sarcomas are confined to one area and have not spread to other parts of the body. These tumors can develop in any part of the body but are most common in the arms, legs, and abdomen. The disease affects both adults and children, with different subtypes occurring at different ages.

Trial ID:

2024-510713-15-00

Protocol code:

ET16-132

NCT ID:

NCT03474094

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study of Atezolizumab Combined with Radiotherapy in Patients with Operable Soft Tissue Sarcomas

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?