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Study on Post-Operative Chemotherapy with Doxorubicin and Trabectedin for Patients with High-Risk Localized Uterine Leiomyosarcoma

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What is this study about?

This clinical trial is focused on studying a type of cancer called uterine leiomyosarcoma, which is a rare cancer that occurs in the smooth muscle tissue of the uterus. The study is specifically looking at cases where the cancer has been surgically removed but is considered high-risk for coming back. The purpose of the study is to see if adding chemotherapy after surgery can help prevent the cancer from returning. The chemotherapy treatment being tested includes two medications: doxorubicin and trabectedin. These medications are given as a solution through an infusion, which means they are delivered directly into the bloodstream through a vein.

Participants in the study will be randomly assigned to one of two groups. One group will receive the chemotherapy treatment with doxorubicin and trabectedin, while the other group will be observed without additional treatment. The study will last for a period of time, during which participants will receive up to four cycles of chemotherapy if they are in the treatment group. The goal is to determine if the chemotherapy helps improve the time patients remain free from cancer recurrence compared to those who do not receive the additional treatment.

Throughout the study, participants will be monitored for any side effects from the treatment, as well as their overall health and quality of life. The study aims to provide valuable information on whether this chemotherapy combination can be beneficial for patients with high-risk uterine leiomyosarcoma after surgery. This research could potentially lead to improved treatment options for patients facing this challenging condition.

1 joining the study

Upon joining the study, the diagnosis of uterine leiomyosarcoma must be confirmed by a pathologist. This confirmation should occur within eight weeks following surgery.

Eligibility criteria include adequate blood, kidney, liver, and heart function, as well as a high-risk CINSARC signature. The patient must not have received prior chemotherapy for sarcoma.

2 randomization

Randomization involves assigning the patient to either the treatment group or the observation group. This step is based on the high-risk CINSARC signature and other eligibility criteria.

3 treatment phase

If assigned to the treatment group, the patient will receive doxorubicin hydrochloride and trabectedin as part of the chemotherapy regimen.

The treatment consists of four cycles of chemotherapy. Each cycle involves the administration of doxorubicin and trabectedin through an infusion.

4 monitoring and follow-up

Throughout the trial, the patient’s health and response to treatment will be monitored. This includes regular assessments to check for any recurrence of the disease or side effects from the treatment.

Quality of life will be evaluated using a questionnaire that assesses various aspects such as pain, physical and emotional functioning, fatigue, and appetite.

5 end of trial

The trial is expected to conclude by September 2030. At the end of the trial, data will be analyzed to determine the effectiveness of the treatment in preventing disease recurrence and improving survival.

Who Can Join the Study?

  • The patient must have a confirmed diagnosis of uterine leiomyosarcoma (a type of cancer in the uterus) obtained less than 8 weeks after surgery.
  • At the time of randomization, all initial inclusion criteria must still be met.
  • The patient must have a high-risk CINSARC signature, which is a specific genetic marker.
  • The diagnosis of uterine leiomyosarcoma must be confirmed by a local expert pathologist or a central study expert pathologist.
  • The patient must have adequate hematologic organ function, meaning:
    • Absolute neutrophil count (a type of white blood cell) of at least 1.5 Giga/L.
    • Hemoglobin (a protein in red blood cells) of at least 9 g/dL.
    • Platelets (cells that help with blood clotting) of at least 100 Giga/L.
  • The patient must have adequate renal function, meaning:
    • Serum creatinine (a waste product in the blood) of 1.5 mg/dL or less, or a creatinine clearance of at least 60 mL/min.
  • The patient must have adequate liver function, meaning:
    • Total bilirubin (a substance made by the liver) within normal limits.
    • Transaminases (liver enzymes) no more than 2.5 times the upper limit of normal.
    • Alkaline phosphatases (another liver enzyme) no more than 1.5 times the upper limit of normal.
  • The patient must have adequate cardiac function, meaning:
    • Shortening fraction (a measure of heart function) greater than 30%.
    • Left Ventricular Ejection Fraction (a measure of how well the heart pumps blood) greater than 50%.
  • The patient must have creatine phosphokinase (CPK) levels no more than 2.5 times the upper limit of normal.
  • The patient must have albumin (a protein in the blood) levels of at least 25 g/L.
  • The patient must sign an informed consent form for the randomized phase, following international and local guidelines.
  • The patient must have an ECOG performance status of 0 or 1, which indicates they are fully active or have some symptoms but can carry out light work.
  • The patient must not have been previously treated with chemotherapy for a sarcoma and must not have received anthracyclines or trabectedin for another cancer.
  • There must be available Formalin Fixed Paraffin Embedded (FFPE) tumor blocks in sufficient quantity and quality for genetic testing.
  • The patient must be between 18 and 75 years old.
  • The patient must have FIGO stage I (2018 classification) uterine leiomyosarcoma, with complete resection (surgical removal) of the tumor.
  • The patient must have no measurable disease, as shown by normal imaging tests done within 4 weeks before joining the study.
  • The patient must sign an informed consent form before any trial-specific procedures, following international and local guidelines.
  • The patient must be part of a social security system or have equivalent private health insurance, as required by local regulations for clinical trial participation.

Who Cannot Join the Study?

  • Patients who have not had surgery to remove the tumor cannot participate.
  • Patients with a different stage of cancer than FIGO stage I cannot participate. FIGO is a system used to describe the size and spread of cancer.
  • Patients who are not considered high risk according to a specific test called the CINSARC NanoCind® signature cannot participate.
  • Patients who are male cannot participate, as the study is only for females.
  • Patients who are part of a vulnerable population, such as those unable to give consent, 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
Oncopole Claudius Regaud Toulouse France
Centr Georges Francois Leclerc Dijon France
Centre Jean Perrin Clermont Ferrand France
Comite Entreprise Paul Papin Angers France
Centre Hospitalier Regional Et Universitaire De Brest Brest France

Other Sites

Site Name City Country Status
Centre Antoine Lacassagne Nice France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Institut Godinot Reims France
Institut Des Neurosciences De La Timone Marseille France
Institut De Cancerologie Strasbourg Europe STRASBOURG, Alsace France
Centre Henri Becquerel Rouen France
Groupe Hospitalier Diaconesses Croix Saint Simon Paris 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
Ass Sportive Du Ctre Alexis Vautrin Vandoeuvre Les Nancy France
Iitgcuvn Rxwhskei Db Cmtngh Df Mjmlpciqdgx Montpellier France
Cdthnb Lsnl Bycuao Lyon France
Igndyfpl Bocsveyf Bordeaux France
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Bzpuevza Uivabfeuvz Hutalcpj Cqderb Besançon France
Cnjite Heplqcmxgad Rremnwho Uwxbtttxmdjox Dk Tsyif Tours France
Iidwyxoe Pqicefhklzxyxwb Cexfwi Chmiwy Marseille France
Cwaeeh Oiwxu Lsdjibq Lille France
Iabkzpvi Cisqe Paris 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
02.09.2024

Trial locations

Investigated drugs:

Doxorubicin is a chemotherapy medication used to treat various types of cancer. In this trial, it is used as part of a combination therapy to help prevent the return of cancer after surgery in patients with high-risk uterine leiomyosarcoma. It works by slowing or stopping the growth of cancer cells.

Trabectedin is another chemotherapy drug included in this trial. It is used alongside doxorubicin to enhance the treatment’s effectiveness in preventing cancer recurrence. Trabectedin interferes with the cancer cell’s DNA, which can lead to cell death and potentially reduce the risk of the cancer coming back after surgery.

Investigated diseases:

Uterine Leiomyosarcoma – Uterine leiomyosarcoma is a rare type of cancer that originates in the smooth muscle tissue of the uterus. It is classified as a soft tissue sarcoma and is known for its aggressive nature. The disease typically presents as a rapidly growing mass in the uterus, which may cause symptoms such as abnormal bleeding, pelvic pain, or a noticeable mass. In its early stages, it may be localized and resectable, meaning it can be surgically removed. However, it has a tendency to recur or spread to other parts of the body, such as the lungs or liver. The progression of uterine leiomyosarcoma can vary, with some cases remaining stable for a period while others may progress more rapidly.

Trial ID:
2023-506350-21-00
Protocol code:
UC-SAR-2212_L-UteCIN
Trial Phase:
Therapeutic exploratory (Phase II)

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