Study on the Effectiveness of Doxorubicin, Ifosfamide, and Dacarbazine in High-Risk Patients with Resectable 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 is a cancer that develops in the soft tissues of the body, such as muscles, fat, and blood vessels. The study is specifically looking at cases where the cancer can be surgically removed and has not spread to other parts of the body. The purpose of the study is to see if adding more chemotherapy before surgery can improve outcomes for patients who are at high risk. Chemotherapy is a treatment that uses drugs to kill cancer cells, and in this study, the drugs being used are doxorubicin, dacarbazine, and ifosfamide. These drugs are given through a process called infusion, where the medication is delivered directly into the bloodstream through a vein.

The study will involve several steps. Initially, patients will receive three cycles of chemotherapy with doxorubicin, followed by surgery to remove the tumor. Some patients will receive additional cycles of chemotherapy before surgery to see if this improves their chances of staying cancer-free. After surgery, patients may also receive radiotherapy, which uses high-energy rays to target and kill any remaining cancer cells. The main goal is to see if this approach helps patients live longer without the cancer coming back or spreading.

Throughout the study, doctors will monitor patients closely to see how well the treatment is working and to check for any side effects. The study will last for several years to gather enough information to determine if the intensified chemotherapy approach is beneficial. The results will help doctors understand if this treatment plan can be used to improve the care of patients with high-risk soft-tissue sarcoma in the future.

1 initial assessment

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

A negative pregnancy test is required for women of childbearing potential. Both men and women must agree to use contraception during the trial and for one year after treatment ends.

2 neoadjuvant chemotherapy – phase 1

The first phase of treatment involves three cycles of chemotherapy before surgery. This is known as neoadjuvant chemotherapy.

The medications used are doxorubicin hydrochloride, dacarbazine, and ifosfamide. These are administered through an intravenous infusion, which means they are given directly into a vein.

Each cycle lasts for a specific period, followed by a rest period to allow the body to recover.

3 surgery

After completing the initial chemotherapy cycles, surgery is performed to remove the soft-tissue sarcoma.

The timing of the surgery is determined based on the response to chemotherapy and the overall health status.

4 neoadjuvant chemotherapy – phase 2

Following surgery, an additional three cycles of chemotherapy are administered. This is an intensified treatment phase aimed at reducing the risk of cancer returning.

The same medications are used: doxorubicin hydrochloride, dacarbazine, and ifosfamide, given through intravenous infusion.

5 radiotherapy (if applicable)

Radiotherapy may be recommended based on the surgical outcomes and the characteristics of the sarcoma.

This treatment uses high-energy rays to target and destroy any remaining cancer cells.

6 follow-up and monitoring

Regular follow-up appointments are scheduled to monitor health status and detect any signs of cancer recurrence.

These appointments include physical exams, imaging tests, and laboratory tests as needed.

Who Can Join the Study?

  • The patient must have a type of cancer called soft-tissue sarcoma, which can be removed by surgery and has not spread to other parts of the body.
  • The cancer must be confirmed by a special network of experts in France.
  • Women who can have children must have a negative pregnancy test before joining the study. Both men and women must agree to use a reliable method of birth control during the study and for one year after stopping treatment.
  • The patient must sign a written consent form to participate in the study.
  • The patient must have social security that complies with French law.
  • The cancer must be classified as Grade 2 or 3 according to a specific grading system, which indicates the aggressiveness of the cancer.
  • A sample of the tumor must be available for research purposes.
  • The patient must not have received any previous treatment for this cancer.
  • The patient must be at least 18 years old.
  • The patient must have a life expectancy of at least 3 months.
  • The patient must have a performance status of 0 or 1 on the ECOG scale, which measures how well they can perform daily activities.
  • The patient must have a measurable disease, meaning the cancer can be measured in size using specific criteria.

Who Cannot Join the Study?

  • Patients with metastatic soft-tissue sarcoma cannot participate. This means the cancer has spread to other parts of the body.
  • Patients who are not considered high-risk CINSARC are excluded. CINSARC is a specific way to assess the risk level of the cancer.
  • Patients who cannot undergo surgery are not eligible. Surgery is a procedure to remove the cancer.
  • Patients who cannot receive chemotherapy are excluded. Chemotherapy is a treatment using drugs to kill cancer cells.
  • Patients who cannot receive radiotherapy are not eligible. Radiotherapy uses high-energy rays to destroy cancer cells.
  • Patients under the age of 18 or over the age of 65 are excluded. The study is for adults between these ages.
  • Patients who are part of a vulnerable population are not eligible. This refers to groups who may need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Oncopole Claudius Regaud Toulouse France
Centr Georges Francois Leclerc Dijon France

Other Sites

Site Name City Country Status
Institut De Cancerologie Strasbourg Europe STRASBOURG, Alsace France
Institut de Cancérologie de l’Ouest Saint-Herblain France
Ibnftuzc Rpwmbott Da Clsuxl Df Mgyozxgzclz Montpellier France
Cqjscb Lpds Bdiwbe Lyon France
Cgzabn Hvdsznzvtjb Eb Urliciglguuwy Dv Lmxnfmg Limoges France
Indmbwtd Pfizpaxwkzxeaha Cuxfgs Cxfwpb Marseille France
Hzdhihxe Ujzgvojfuahrgz Sqllzkphjf &wferza Hwahqcd dp Hrgaqelufrc STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
11.02.2019

Trial locations

Doxorubicin is a chemotherapy medication used in this trial. It is part of the treatment plan for patients with high-risk soft-tissue sarcomas. The trial is investigating whether adding more cycles of doxorubicin before surgery can improve patient outcomes. Doxorubicin works by slowing or stopping the growth of cancer cells.

Investigated diseases:

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 muscle, fat, blood vessels, nerves, tendons, and the lining of the joints. The disease is characterized by the growth of abnormal cells that form a mass or tumor. It is considered resectable when the tumor can be surgically removed and non-metastatic when it has not spread to other parts of the body. The progression of soft-tissue sarcoma can vary, with some tumors growing slowly and others more rapidly. The risk of recurrence or spread depends on various factors, including the size and location of the tumor.

Trial ID:
2023-509489-39-00
Protocol code:
IB2017-04
NCT ID:
NCT03805022
Trial Phase:
Therapeutic confirmatory (Phase III)

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