Study Comparing Trabectedin and Gemcitabine for Patients with Advanced or Metastatic Leiomyosarcoma After Chemotherapy

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What is this study about?

This clinical trial is focused on studying a type of cancer called leiomyosarcoma, which can either spread to other parts of the body (metastatic) or grow in a specific area (locally advanced). The study is comparing two treatments: Trabectedin and Gemcitabine. Both medications are given as a solution through a vein, known as an infusion. The purpose of the study is to compare how well these treatments work in patients who have already received chemotherapy based on a drug called anthracycline.

Participants in the study will receive either Trabectedin or Gemcitabine. The study will observe how the cancer responds to these treatments over time. The main focus is on the growth modulation index (GMI), which is a way to measure how the cancer’s growth is affected by the treatment. A GMI greater than 1.33 is considered a positive sign in this type of study. The study will also look at other factors, such as how long patients live, how long they live without the cancer getting worse, and how safe and tolerable the treatments are.

The study will continue for a period of time, during which patients will be monitored regularly to assess the effectiveness and safety of the treatments. The goal is to gather information that could help improve treatment options for patients with advanced leiomyosarcoma. This study is part of ongoing research to find better ways to manage and treat this type of cancer.

1 joining the study

Upon joining the study, the patient will be randomly assigned to receive either trabectedin or gemcitabine as a treatment for metastatic or locally advanced leiomyosarcoma.

The patient must have completed any previous cancer treatments at least 21 days before starting the study medication.

2 treatment administration

The patient will receive the assigned medication through an intravenous infusion. This means the medication will be delivered directly into the bloodstream through a vein.

For gemcitabine, the concentration is 100 mg/ml. The specific dosage and frequency will be determined by the healthcare provider based on individual patient needs.

For trabectedin, the available dosages are 0.25 mg and 1 mg. The healthcare provider will determine the appropriate dosage and frequency.

3 monitoring and assessments

Throughout the trial, the patient’s response to the treatment will be monitored using imaging tests and other assessments to evaluate the size and progression of the tumor.

The patient’s overall health, including blood counts and organ function, will be regularly checked to ensure safety and adjust treatment as necessary.

4 evaluation of treatment effectiveness

The effectiveness of the treatment will be measured by comparing the time it takes for the disease to progress with the current treatment to the time it took with previous treatments.

A key measure is the growth modulation index (GMI), which helps determine the activity of the treatment. A GMI greater than 1.33 is considered a positive sign.

5 completion of the trial

The trial is expected to continue until January 18, 2026, or until the patient completes the treatment protocol.

Upon completion, the patient’s overall response to the treatment, including survival rates and any side effects experienced, will be evaluated.

Who Can Join the Study?

Patients must have a confirmed diagnosis of leiomyosarcoma, which is a type of cancer that affects smooth muscle tissue.
All previous cancer treatments must have been completed at least 3 weeks (21 days) before starting the study drug.
Any side effects from previous treatments, except hair loss, must be reduced to a mild level, as defined by specific medical guidelines.
Patients must have adequate bone marrow, liver, and kidney function, as shown by specific blood tests:

Hemoglobin level of at least 9 g/dl.
White blood cell count (neutrophils) of at least 1,500 per mm³.
Platelet count of at least 100,000 per mm³.
Total bilirubin within normal limits.
Liver enzymes (AST/ALT) no more than 2.5 times the normal limit.
Alkaline phosphatase no more than 2.5 times the normal limit.
Blood clotting tests (PT-INR/PTT) less than 1.5 times the normal limit.
Serum creatinine within 1.5 times the normal limit or a creatinine clearance of at least 30 mL/min.
Albumin level of at least 25 g/l.
Creatine phosphokinase (CPK) no more than 2.5 times the normal limit.

The heart’s pumping ability (Left Ventricular Ejection Fraction) must be at least 50%.
Women who can have children must have a negative pregnancy test before each chemotherapy cycle. Both men and women must agree to use effective birth control during the study and for a period after the study ends.
No history of blood clots in the arteries or veins in the past 12 months.
Patients or their legal representatives must be able to read and understand the consent form and agree to participate in the study.
Patients must have unresectable (cannot be removed by surgery) or metastatic (spread to other parts of the body) leiomyosarcoma.
Patients must have received previous treatment with Anthracycline-based chemotherapy for advanced disease.
Patients must be suitable to receive gemcitabine or Trabectedin therapy.
Patients must have measurable or evaluable disease according to specific criteria (RECIST 1.1).
There must be evidence of disease progression within 6 months before entering the study, according to RECIST 1.1 criteria.
Availability of specific dates related to previous treatments and assessments is required.
Patients must be at least 18 years old.
Patients must have an ECOG Performance Status of 2 or less, which is a measure of their ability to perform daily activities.

Who Cannot Join the Study?

Patients who have not been previously treated with anthracycline-based chemotherapy. This is a type of cancer treatment that uses drugs to kill cancer cells.
Patients who have a different type of cancer other than leiomyosarcoma, which is a rare type of cancer that affects smooth muscle tissue.
Patients who are part of a vulnerable population, meaning they might have special needs or circumstances that require extra protection.
Patients who are not within the specified age range for the study.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
IRCCS Humanitas Research Hospital	Rozzano	Italy

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Centro Di Riferimento Oncologico Di Aviano	Aviano	Italy
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Istituto Ortopedico Rizzoli	Bologna	Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone	Palermo	Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga	Orbassano	Italy
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS	Candiolo	Italy
Ospedale San Giovanni Bosco	Turin	Italy
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Azienda USL Toscana Centro	Prato	Italy
Universita’ Campus Bio-medico Di Roma	Rome	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Pmfqaroxklh Ssdoyzioklkupjpbp	Bologna	Italy
Irhszuez Rleriharf Peh La Swoeul Dli Tkosfw Dfny Agbwzww Iiho Suypyh	Meldola	Italy
Icoavo Ihbmdxji Fimhxggfyormh Oreslyvrskz	Rome	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	18.01.2022

Trial locations

Investigated drugs:

Trabectedin is a medication used in this trial to treat patients with metastatic or locally advanced leiomyosarcoma. It is being tested to see how well it can slow down or stop the growth of cancer cells in patients who have already received other chemotherapy treatments. Trabectedin works by interfering with the DNA in cancer cells, which may help to prevent them from growing and spreading.

Gemcitabine is another medication being tested in this trial for the same type of cancer. It is used to see if it can effectively control the disease in patients who have previously been treated with chemotherapy. Gemcitabine works by blocking the ability of cancer cells to make DNA, which is necessary for them to grow and divide. This may help to slow down or stop the progression of the cancer.

Investigated diseases:

Leiomyosarcoma – Leiomyosarcoma is a type of cancer that originates in smooth muscle tissue, which is found in various parts of the body such as the uterus, stomach, and blood vessels. It is considered a rare form of cancer and can be either localized or metastatic, meaning it can spread to other parts of the body. The disease often begins as a painless lump or swelling and may grow slowly or rapidly, depending on the individual case. As it progresses, it can cause symptoms related to the area of the body it affects, such as abdominal pain or swelling if it occurs in the abdomen. The progression of leiomyosarcoma can vary significantly between patients, with some experiencing slow growth and others facing more aggressive disease.

Trial ID:

2024-513820-40-00

NCT ID:

NCT04383119

Trial Phase:

Therapeutic exploratory (Phase II)

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Study Comparing Trabectedin and Gemcitabine for Patients with Advanced or Metastatic Leiomyosarcoma After Chemotherapy

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