Study on the Effectiveness of Doxorubicin, Ifosfamide, and Dacarbazine in High-Risk Soft Tissue Sarcoma Patients

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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. The study aims to explore the effectiveness of adding chemotherapy before and after surgery in patients with this cancer, who are considered high-risk based on a specific test called CINSARC. The chemotherapy treatment being tested includes medications such as Ifosfamide, Doxorubicin, and Dacarbazine Citrate. These medications are given through an intravenous infusion, which means they are administered directly into the bloodstream through a vein.

The purpose of the study is to determine if this additional chemotherapy can help prevent the cancer from spreading to other parts of the body, which is known as metastasis. Participants in the study will receive up to four cycles of chemotherapy, with each cycle lasting a few weeks. The study will compare the outcomes of patients receiving this treatment with those who receive the standard management for Soft Tissue Sarcoma.

Throughout the study, the health and progress of the participants will be closely monitored to assess the safety and effectiveness of the treatment. The main focus will be on how long patients remain free from metastasis, as well as their overall survival and any side effects experienced during the treatment. The study is expected to continue for several years to gather comprehensive data on the long-term benefits and risks of the chemotherapy regimen being tested.

1 joining the study

Upon joining the study, a diagnosis of soft tissue sarcoma must be confirmed. This involves a histological confirmation by a specialized network.

Consent is required, and eligibility criteria must be met, including age, health insurance affiliation, and specific health conditions.

2 initial assessment

An initial assessment is conducted to evaluate health status. This includes blood tests to check blood cell counts, kidney and liver function, and heart function.

A chest CT scan is performed to ensure the disease is localized and resectable.

3 treatment phase

The treatment involves 4 cycles of chemotherapy using doxorubicin, ifosfamide, and dacarbazine. These medications are administered intravenously.

Each cycle includes specific dosages and schedules, which are determined by the medical team based on individual health conditions.

4 monitoring and follow-up

Regular monitoring is conducted to assess the response to treatment and manage any side effects. This includes periodic imaging and blood tests.

Follow-up visits are scheduled to evaluate overall health and disease status, focusing on metastasis-free survival and disease-free survival.

5 end of study

The study is expected to conclude by February 2029. At this point, final assessments are made to determine the long-term outcomes of the treatment.

The primary endpoint is to evaluate metastasis-free survival, while secondary endpoints include disease-free survival and overall survival.

Who Can Join the Study?

Must have a confirmed diagnosis of soft tissue sarcoma, which is a type of cancer that occurs in the soft tissues of the body.
Must have a high-risk CINSARC signature, which is a specific genetic marker used to assess the risk level of the cancer.
Must have acceptable hematologic function, meaning the blood cells are within a certain range: Absolute neutrophil count (ANC) of at least 1.5 G/L, platelet count of at least 100 G/L, and hemoglobin greater than 9g/dL.
Must have acceptable renal function, meaning the kidneys are working well: Serum creatinine should be 1.5 times the normal limit or less, or creatinine clearance should be at least 60 mL/min.
Must have acceptable liver function, meaning the liver is working well: Bilirubin should be 1.5 times the normal limit or less, and AST (SGOT) and ALT (SGPT) should be 2.5 times the normal limit or less.
Must have a normal LVEF (left ventricular ejection fraction) of more than 50%, which measures how well the heart is pumping blood.
Tumors must be graded as 1, 2, or 3 according to the FNCLCC grading system, which is a way to classify the severity of the cancer.
The disease must be resectable and localized, meaning it can be surgically removed and has not spread, confirmed by a chest-CT scan.
There should be 6 weeks or less between surgical removal of the tumor and joining the study, if surgery was done before joining.
Must have an available archived FFPE tumor sample, which is a preserved sample of the tumor tissue, in enough quantity for testing.
Must be 18 years of age or older.
Must have an ECOG performance status of 2 or less, which is a scale that measures the ability to perform daily activities.
Must have a life expectancy of at least 12 weeks after starting the treatment.
Women must be post-menopausal or agree to use effective birth control during treatment and for a specified time after treatment ends. Non-menopausal women must have a negative pregnancy test before joining. Men must agree to use effective birth control during treatment and for at least 3 months after treatment ends.
Must have signed a written informed consent, agreeing to participate in the study.
Must be affiliated with a Social Health Insurance in France.

Who Cannot Join the Study?

Patients who do not have a diagnosis of 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 not considered high-risk according to CINSARC cannot participate. CINSARC is a tool used by doctors to assess the risk level of certain cancers.
Patients who are younger than 4 years old or older than 18 years old cannot participate.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups like pregnant women or people who cannot make decisions for themselves.

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
Centre Jean Perrin	Clermont Ferrand	France
Institut De Cancerologie De Lorraine	Vandoeuvre Les Nancy	France

Other Sites

Site Name	City	Country
Centre Antoine Lacassagne	Nice	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Institut Godinot	Reims	France
Institut De Cancerologie Strasbourg Europe	STRASBOURG, Alsace	France
Centre Henri Becquerel	Rouen	France
Hopital Beaujon	Clichy	France
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Centre Francois Baclesse	Caen	France
Centre De Lutte Contre Le Cancer Eugene Marquis	Rennes	France
Iefzdxhf Rnktengj Dr Cnunkq Dn Mgckvzwjhes	Montpellier	France
Cnayxk Ljqk Brjauo	Lyon	France
Cvvlkb Hxfywnmbppn El Uzuchwmqwobnh Dv Lrlnigd	Limoges	France
Ajsuefrjlq Pdbhwnxu Hetqlgpm Da Mafvcsmtc	Marseille	France
Bicwkjsp Udoqxozdqe Higzwapn Czalbo	Besançon	France
Iouerwat Pubjumpyaigeazp Cvqzms Cnsqdq	Marseille	France
Hxlsoqbj Uccoinvcczgoax Sunrubfbml &bnkega Hpirydc da Hmqldoxkprm	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	03.02.2020

Trial locations

Investigated drugs:

Doxorubicin is a chemotherapy medication used in this trial. It is part of the treatment plan to see if it can help improve the chances of survival without the cancer spreading in patients with high-risk soft tissue sarcoma. The study is testing whether adding this medication before and after surgery can be more effective than the usual treatment approach.

Investigated diseases:

Soft tissue sarcoma

Soft Tissue Sarcoma – Soft Tissue Sarcoma is a type of cancer that begins in the soft tissues of the body, such as muscles, fat, blood vessels, nerves, tendons, and the lining of joints. It can occur in any part of the body but is most commonly found in the arms, legs, and abdomen. The disease often starts as a painless lump or swelling, which may grow over time. As it progresses, it can invade nearby tissues and organs, potentially leading to pain or other symptoms depending on its location. The growth rate and behavior of the tumor can vary significantly, with some types growing slowly and others more rapidly. The risk of metastasis, or spread to other parts of the body, is a concern, particularly in high-risk cases.

Trial ID:

2024-515384-62-00

Protocol code:

19SARC05

NCT ID:

NCT04307277

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness of Doxorubicin, Ifosfamide, and Dacarbazine in High-Risk Soft Tissue Sarcoma Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?