Study on the Effectiveness of Atezolizumab with Radiotherapy for Patients with Metastatic Colorectal, Lung, Renal, and Sarcoma Cancers

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for patients with metastatic tumors, which are cancers that have spread to other parts of the body. The specific types of cancer being studied include colorectal cancer, non-small cell lung cancer, renal cell carcinoma, and sarcoma. The treatment being tested combines a medication called atezolizumab with a type of radiation therapy known as stereotactic ablative radiotherapy (SABR). Atezolizumab is an anti-PD-L1 antibody, which is a type of protein designed to help the immune system fight cancer cells.

The purpose of this study is to evaluate how effective this combination treatment is in preventing the cancer from getting worse over a period of one year. During the study, patients will receive atezolizumab through an intravenous (IV) infusion, which means the medication is given directly into a vein. They will also undergo SABR, a precise form of radiation therapy that targets the cancer cells while minimizing damage to surrounding healthy tissue. The study will monitor patients’ health and the progression of their cancer over time.

Participants in the study will be observed to see if the treatment helps keep their cancer from progressing and to assess any side effects they may experience. The study aims to provide valuable information on the potential benefits and risks of using atezolizumab in combination with SABR for treating metastatic tumors. This research could contribute to developing more effective treatment options for patients with these types of cancer.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

Laboratory tests are performed to ensure adequate organ function. These tests include blood counts and liver function tests.

Imaging studies are conducted to document the presence of metastatic tumors.

2 treatment planning

A treatment plan is developed, which includes the administration of atezolizumab and stereotactic ablative radiotherapy (SABR).

The specific sites for radiotherapy are identified, and a schedule for treatment is established.

3 atezolizumab administration

Atezolizumab is administered through an intravenous infusion. The dosage and frequency are determined by the study protocol.

The duration of atezolizumab treatment is specified in the study plan, and regular monitoring is conducted to assess response and manage any side effects.

4 stereotactic ablative radiotherapy (SABR)

SABR is delivered to the identified tumor sites. The treatment is precisely targeted to minimize exposure to surrounding healthy tissue.

The number of SABR sessions and the intervals between them are determined based on the treatment plan.

5 follow-up assessments

Regular follow-up assessments are conducted to monitor the effectiveness of the treatment and to check for any progression of the disease.

These assessments include imaging studies and laboratory tests, as well as evaluations of overall health and well-being.

6 end of study evaluation

At the end of the study period, a comprehensive evaluation is performed to assess the outcomes of the treatment.

The final assessment includes a review of all collected data and a discussion of the results with the patient.

Who Can Join the Study?

Patients must be 18 years of age or older.
Patients must not have any major health conditions that would make it unsafe to receive the study treatment.
The areas of the tumor that will be treated and not treated must be accessible for a biopsy, which is a procedure to take a small sample of tissue for testing. Additional written consent is required for this.
Patients must be part of a social security system.
Patients must have a confirmed diagnosis of metastatic solid tumors, which include colorectal, non-small cell lung, renal, and sarcoma cancers. These tumors must have been treated according to current standard recommendations, but the specific groups for these cancers are closed to new participants.
Patients must have at least one tumor that can be measured and treated with a specific type of radiation therapy called SABR (Stereotactic Ablative Radiotherapy), and it must be 4 cm or smaller. They must also have at least one tumor that will not be treated but can be measured. Tumors in certain areas like the brain or specific parts of the lungs are not eligible for treatment in this study.
Patients must have a WHO performance status of 0-1, which means they are fully active or have some symptoms but do not need to stay in bed for more than half of the day.
Patients must be evaluated by a radiation oncologist within 45 days before joining the study, including imaging tests to check the tumors.
Patients must have adequate organ function, which will be checked through blood tests. These tests include:
- Enough white blood cells (neutrophils and lymphocytes) to fight infections.
- Enough platelets to help with blood clotting.
- Enough hemoglobin, which carries oxygen in the blood.
- Proper kidney function, measured by creatinine clearance.
- Proper liver function, measured by bilirubin and liver enzymes (ALT and AST).
Patients must have a life expectancy of more than 3 months.
Patients must understand that the treatment is experimental and provide written informed consent to participate.
Sexually active women who can become pregnant must agree to use a highly effective method of birth control, along with a barrier method like a condom, or choose to abstain from sex during the study and for at least 5 months after the last dose of the study drug. Men must agree to use a condom during the study and for at least 90 days after the treatment. Their female partners should also use a highly effective method of birth control. Women who are not postmenopausal or surgically sterile must have a negative pregnancy test before starting the study.

Who Cannot Join the Study?

Patients with metastatic tumors (cancer that has spread to other parts of the body) in the following types: colorectal, non-small cell lung, renal, and sarcoma cannot participate.
Patients who are not within the specified age range for the study.
Patients who are not part of the specified clinical trial groups.
Patients who are not male or female, as both genders are included in the study.
Patients who are considered part of a vulnerable population (groups that may have additional risks or require special considerations) cannot participate.

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
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France

Other Sites

Site Name	City	Country
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Cokdml Ldab Bzfcjw	Lyon	France
Iynhdrwu dy Chhxsbvckutp Hmyglwjvutb Uocblkbjapwxf dj Sgsib Ejcctcw (jizjidp	Saint Priest En Jarez	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	15.11.2016

Trial locations

Investigated drugs:

Atezolizumab

Atezolizumab is a type of medication known as an anti-PD-L1 antibody. It works by helping your immune system recognize and attack cancer cells. In this clinical trial, atezolizumab is being used to see if it can help stop the growth of metastatic tumors when combined with a special type of radiation therapy.

Stereotactic Ablative Radiotherapy (SABR) is a form of radiation therapy that delivers very precise, high doses of radiation to cancer cells. The goal of SABR is to destroy the cancer cells while minimizing damage to the surrounding healthy tissue. In this trial, SABR is used alongside atezolizumab to see if the combination is more effective in treating metastatic tumors.

Investigated diseases:

Metastatic Colorectal Cancer – This disease occurs when cancer that originated in the colon or rectum spreads to other parts of the body, such as the liver or lungs. The progression involves cancer cells breaking away from the primary tumor and traveling through the bloodstream or lymphatic system. These cells then form new tumors in other organs. As the disease advances, it can affect the function of the organs involved. The spread of cancer can lead to various symptoms depending on the organs affected. The disease is characterized by its ability to invade distant tissues and organs.

Metastatic Non-Small Cell Lung Cancer – This type of cancer begins in the lungs and spreads to other parts of the body, such as the brain, bones, or liver. The progression involves cancer cells detaching from the original lung tumor and traveling through the blood or lymphatic system. These cells establish new tumors in other organs, disrupting their normal function. As the disease progresses, it can cause symptoms related to the affected organs. The spread of cancer cells is a key feature of this disease. It is known for its ability to invade distant tissues and organs.

Metastatic Renal Cell Carcinoma – This disease starts in the kidneys and spreads to other parts of the body, such as the lungs, bones, or liver. The progression involves cancer cells leaving the primary kidney tumor and traveling through the bloodstream or lymphatic system. These cells form new tumors in other organs, affecting their function. As the disease advances, it can lead to symptoms based on the organs involved. The spread of cancer is a defining characteristic of this condition. It is marked by its ability to invade distant tissues and organs.

Metastatic Sarcoma – This type of cancer originates in the bones or soft tissues and spreads to other parts of the body, such as the lungs or liver. The progression involves cancer cells detaching from the primary tumor and traveling through the blood or lymphatic system. These cells establish new tumors in other organs, impacting their normal function. As the disease progresses, it can cause symptoms related to the affected organs. The spread of cancer cells is a key feature of this disease. It is characterized by its ability to invade distant tissues and organs.

Trial ID:

2024-515678-29-00

Protocol code:

2015/2335

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effectiveness of Atezolizumab with Radiotherapy for Patients with Metastatic Colorectal, Lung, Renal, and Sarcoma Cancers

What is this study about?

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Who Cannot Join the Study?