Study on Pembrolizumab and Radiotherapy for Patients with High-Risk Soft Tissue Sarcoma in the Limbs

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What is this study about?

This clinical trial is focused on studying a type of cancer called high-risk soft tissue sarcoma that occurs in the arms or legs. This includes specific subtypes like undifferentiated pleomorphic sarcoma and dedifferentiated/pleomorphic liposarcoma. The study is investigating a treatment involving a medication called pembrolizumab, which is also known by the brand name KEYTRUDA. Pembrolizumab is given as a solution through an intravenous infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of the study is to see if using pembrolizumab along with radiotherapy before surgery, and continuing with pembrolizumab after surgery, can help improve the time patients remain free from the disease compared to using only radiotherapy before surgery. The study involves two groups of patients: one group will receive pembrolizumab with radiotherapy before surgery and continue with pembrolizumab after surgery, while the other group will receive only radiotherapy before surgery. The study aims to assess the safety and effectiveness of pembrolizumab in treating this type of cancer.

Participants in the study will undergo a series of treatments and follow-ups over a period of time. The study will monitor how well the treatment works in preventing the cancer from coming back and will also look at the overall survival of the patients. The study is expected to continue until 2028, providing valuable information on the potential benefits of pembrolizumab for patients with high-risk soft tissue sarcoma of the extremity.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history, imaging tests, and laboratory tests to ensure the presence of a high-risk soft tissue sarcoma of the extremity.

Eligibility criteria include being 12 years or older, having a tumor size greater than 5 cm, and having adequate organ function. A negative pregnancy test is required for women of childbearing potential.

2 treatment group assignment

Participants are randomly assigned to one of two groups. The first group receives neoadjuvant pembrolizumab with radiotherapy, followed by surgery and adjuvant pembrolizumab. The second group receives radiotherapy followed by surgery.

3 neoadjuvant treatment

For those in the first group, pembrolizumab is administered as an intravenous infusion. The dosage is 200 mg every three weeks, combined with radiotherapy targeting the tumor.

This phase aims to reduce the tumor size before surgical removal.

4 surgical resection

Surgery is performed to remove the tumor. This step is crucial for both groups and is scheduled after the completion of the neoadjuvant treatment phase.

5 adjuvant treatment

Participants in the first group receive additional pembrolizumab infusions post-surgery. The dosage remains 200 mg every three weeks, continuing for up to one year or until disease progression.

6 follow-up and monitoring

Regular follow-up visits are scheduled to monitor health status and detect any signs of disease recurrence. These visits include physical examinations, imaging tests, and laboratory tests.

The primary goal is to assess disease-free survival, with secondary evaluations of recurrence-free survival and overall survival.

Who Can Join the Study?

Must be 12 years or older.
Must have a confirmed diagnosis of a specific type of soft tissue sarcoma in the arms or legs. This includes certain types of tumors that are larger than 5 cm.
Can have certain other types of cancer, like non-melanoma skin cancer, early-stage prostate cancer, or in situ carcinoma.
Must have an ECOG Performance Status of 0 or 1, which means being fully active or having some symptoms but still able to do light work.
The primary tumor must be resectable, meaning it can be surgically removed, and there should be no signs of cancer spreading to other parts of the body.
Must have adequate organ function, which includes:
- Enough neutrophils, a type of white blood cell, to fight infection.
- Enough platelets to help with blood clotting.
- Enough hemoglobin in the blood, which carries oxygen.
- Normal kidney function, measured by creatinine levels.
- Normal levels of liver enzymes (ALT and AST).
- Normal bilirubin levels, which is a substance made by the liver.
- Enough albumin, a protein in the blood.
Must provide written, voluntary informed consent to participate in the study.
Men and women who can have children must agree to use effective birth control during the study and for 120 days after the last dose of the study drug.
Women who can have children must have a negative pregnancy test within 72 hours before starting the study.

Who Cannot Join the Study?

Patients with a different type of cancer than the one being studied cannot participate.
Patients with a tumor size less than or equal to 5 cm cannot participate.
Patients with a tumor grade lower than 2 out of 3 cannot participate. Tumor grade refers to how much the cancer cells look like normal cells under a microscope. A higher grade means the cells look less like normal cells and may grow or spread more quickly.
Patients who are not able to undergo surgery cannot participate.
Patients who cannot receive radiotherapy cannot participate. Radiotherapy is a treatment that uses high doses of radiation to kill cancer cells or shrink tumors.
Patients who cannot receive pembrolizumab cannot participate. Pembrolizumab is a type of medication used to help the immune system fight cancer.
Patients who are pregnant or breastfeeding cannot participate.
Patients with certain medical conditions that might interfere with the study cannot participate.
Patients who are participating in another clinical trial cannot participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	01.04.2019

Trial locations

Investigated drugs:

Pembrolizumab

Pembrolizumab is a medication used in this trial to help the body’s immune system fight cancer. It is given to patients before and after surgery to see if it can improve the chances of the cancer not coming back. Pembrolizumab works by blocking a specific protein that prevents the immune system from attacking cancer cells, allowing the immune system to better target and destroy them.

Radiotherapy is a treatment that uses high-energy rays to kill cancer cells. In this trial, it is used before surgery to shrink the tumor and make it easier to remove. The goal is to see if combining radiotherapy with pembrolizumab before surgery can improve the outcomes for patients with high-risk soft tissue sarcoma.

Undifferentiated Pleomorphic Sarcoma – This is a type of soft tissue sarcoma that typically occurs in the extremities, such as arms or legs. It is characterized by a mix of different cell types that appear disorganized under a microscope. The disease often presents as a large, painless mass that can grow rapidly. As it progresses, it may invade nearby tissues and has the potential to spread to other parts of the body. The tumor is usually graded based on its appearance and growth rate, with higher grades indicating more aggressive behavior.

Dedifferentiated Liposarcoma – This is a subtype of liposarcoma, a cancer that arises in fat cells, and is known for its aggressive nature. It typically starts as a well-differentiated liposarcoma and then transforms into a more aggressive form. The tumor often appears as a large mass in the extremities and can grow quickly. As it progresses, it may invade surrounding tissues and has the potential to metastasize to distant sites. The disease is graded based on the degree of cellular abnormality and growth rate, with higher grades indicating a more aggressive form.

Trial ID:

2024-517858-10-00

Protocol code:

SU2C-SARC032

NCT ID:

NCT03092323

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Pembrolizumab and Radiotherapy for Patients with High-Risk Soft Tissue Sarcoma in the Limbs

What is this study about?

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