Study on intensified chemotherapy for Resectable Soft-tissue Sarcomas treatment

Recruting new patients

Select region:

Navigation:

    What is this study about?

    This study aims to investigate whether administering additional chemotherapy before surgery can benefit individuals with soft-tissue sarcoma, a specific type of cancer. Currently, the standard treatment involves three doses of chemotherapy before surgery, sometimes followed by radiotherapy after surgery. In this study, some participants will follow this standard treatment plan, while others will receive an intensified regimen involving six doses of chemotherapy before surgery instead of three. Researchers will observe and compare outcomes such as the time it takes for the cancer to spread or worsen, overall survival rates, the extent of tumor shrinkage with the additional chemotherapy, and any potential side effects associated with the treatment.

    Learn more about this Trial

      I accept the Terms of Use and Privacy Policy*

       I consent to the Service Operator sending commercial information*

      I consent to the Service Operator using telecommunications terminal devices and automatic calling systems in marketing communications*

      Success

      Your form submitted successfully!

      Error

      Sorry! your form was not submitted properly, Please check the errors above.

      Locations

      Where does the clinical trial take place?

      Bordeaux , France

      Dijon , France

      Limoges , France

      Lyon Cedex 08 , France

      Marseille , France

      Montpellier , France

      Saint-Herblain , France

      Strasbourg , France

      Toulouse , France

      Villejuif , France

      You can join this study in:

      Study Steps

      How Complex Will My Study Be and What Phases Will I Go Through?

      In this clinical trial, patients will follow different steps depending on which group they are assigned to:

      • Arm A (Standard Management): Patients receive 3 cycles of neoadjuvant doxorubicin-based chemotherapy followed by surgery, and if indicated, radiotherapy may be prescribed at the discretion of the investigator9†source.
      • Arm B (Experimental Arm): Patients receive 6 cycles of neoadjuvant doxorubicin-based chemotherapy followed by surgery, and similarly to Arm A, radiotherapy may be prescribed at the discretion of the investigator if indicated10†source.

      For low-risk CINSARC patients, the treatment is at the discretion of the investigator. The chemotherapy includes doxorubicin and ifosfamide or dacarbazine as per local practices, based on a 21-day cycle.

      Please note that these are the steps for high-risk CINSARC patients; if your situation differs, there might be variations in this protocol.


      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To be eligible to join the study based on disease criteria, you must have a histologically confirmed soft-tissue sarcoma. However, certain histological subtypes of soft-tissue sarcoma are excluded:

      1. Well-differentiated liposarcoma
      2. Alveolar soft-part sarcoma
      3. Dermatofibrosarcoma protuberans
      4. Clearcell sarcoma
      5. Embryonal and alveolar rhabdomyosarcoma【13†source】.


      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      Certainly, here’s a list of conditions you must meet to join the study, with explanations of medical terms:

      1. Histologically confirmed soft-tissue sarcoma: Your soft-tissue sarcoma must be confirmed by a laboratory examination of tissue under a microscope by the RRePS network, as recommended by the French NCI.
      2. Grade 2 or 3 soft-tissue sarcoma: According to the FNCLCC grading system, which classifies sarcomas based on different histological factors to predict the tumor’s aggressiveness, your sarcoma should be classified as either grade 2 or 3.
      3. Available archived tumor sample: A sample of your tumor must be accessible for research purposes.
      4. Non-metastatic and resectable disease: The sarcoma has not spread to other parts of the body (non-metastatic) and can be surgically removed (resectable).
      5. No prior treatment: You should not have previously received any treatment for the sarcoma.
      6. Age 18 or older: You must be at least 18 years of age.
      7. Life expectancy greater than 3 months: You should have a life expectancy of more than three months.
      8. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1: Your physical ability to perform daily activities should not be greatly impacted. An ECOG PS of 0 indicates you are fully active, whereas 1 indicates you are restricted in physically strenuous activity but can carry out light work.
      9. Measurable disease: You must have at least one tumor lesion that can be measured using a standard set of criteria called RECIST v1.1. For regular lesions, the size must be at least 10 mm, or at least 15 mm for adenopathy (swollen lymph nodes).
      10. Negative serum pregnancy test and agreed contraception: If you are a woman who can bear children, you must test negative for pregnancy before study entry. All participants must use effective contraception during the study and for one year after.
      11. Signed and dated informed consent: You must voluntarily agree to participate in the study by signing a consent form.
      12. Social security compliance: You must have social security that complies with French law.

      【9†source】

      What Reasons Could Exclude Me from the Study?

      Certainly! Below is the list of exclusion criteria for the study, with explanations of medical terms where necessary:

      1. Specific Histological Subtypes of Soft-tissue Sarcoma: You cannot take part if you have certain types of sarcoma, including well-differentiated liposarcoma, alveolar soft-part sarcoma, dermatofibrosarcoma protuberans, clear cell sarcoma, embryonal and alveolar rhabdomyosarcoma.
      2. Prior or Concurrent Malignant Disease: If you have been diagnosed with or treated for another type of cancer in the last 2 years (with some exceptions for specific treated cancers).
      3. Contraindication to Specific Chemotherapy: You cannot participate if you have any contraindications to the chemotherapy drugs anthracycline, ifosfamide or dacarbazine.
      4. Recent Participation in Another Medical Study: If you have taken part in another study involving a medical or therapeutic intervention within the last 28 days.
      5. Infections: Known infections with HIV, hepatitis B, or hepatitis C preclude participation.
      6. Pregnancy and Breast-Feeding: Females who are currently pregnant or are breast-feeding cannot participate.
      7. Medical Conditions that Interfere with the Study: Other medical conditions that, in the judgment of the investigator, may interfere with the conduct of the study.
      8. Deprivation of Liberty or Legal Guardianship: Individuals deprived of liberty or placed under legal guardianship are excluded.
      9. Unwillingness or Inability to Comply with Protocol: Any unwillingness or inability to comply with the study protocol for any reason. This includes following all the study visits, tests, and procedures according to the study plan【9†source】.

      Please note that the explanations provided aim to make medical terms understandable, but for any conditions or terms that are unclear, you should consult with a healthcare professional for further explanation.


      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The clinical trial involves the following drugs:

      1. Doxorubicin (active substance: Doxorubicin) – an anthracycline type of chemotherapy used to treat various types of cancer. It works by interfering with the growth of cancer cells, which are eventually destroyed.
      2. Ifosfamide (active substance: Ifosfamide) – an alkylating agent used in chemotherapy that attaches an alkyl group to the DNA of a cancer cell, which interferes with the cell’s DNA and inhibits its ability to reproduce.
      3. Dacarbazine (active substance: Dacarbazine) – a triazene alkylating drug used as chemotherapy. It works by slowing or stopping the growth of cancer cells in the body.
      4. Other drugs are at the discretion of the investigator for low-risk CINSARC patients【9†source】.

      Please note that the use of these drugs may vary based on the arm of the trial a patient is in and whether they are considered high-risk or low-risk.

      Have the Medicinal Substances Used in the Trial Been Previously Studied in Medicine?

      The active substances participating in the clinical trial are known to medicine and the medical literature. Here is a list of the substances:

      1. Doxorubicin – a type of chemotherapy medication used to treat cancer. It works by slowing or stopping the growth of cancer cells.
      2. Liposomal doxorubicin – a modified form of doxorubicin that is enclosed in a liposome. It is used to treat various types of cancer.
      3. Ifosfamide – an alkylating agent used in chemotherapy for the treatment of cancer. It interferes with the growth of cancer cells, which are eventually destroyed.
      4. Isophosphamide mustard – a derivative of ifosfamide and a type of alkylating agent used in cancer treatment as well.
      5. Dacarbazine – a medication used in chemotherapy for the treatment of various types of cancer. It works by slowing or stopping the growth of cancer cells.

      These substances are documented and researched in the field of oncology for their efficacy and utility in cancer treatment.


      Study ID

      CT-EU-00088699

      Recruitment status

      Recruting new patients

      Start of the trial

      5 years ago

      Study phase

      Phase
      III