Study on Ifosfamide and Doxorubicin for Patients with High-Grade Soft Tissue Sarcoma in the Limbs and Trunk Wall

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What is this study about?

This clinical trial is focused on studying a type of cancer called high-grade soft tissue sarcoma, which affects the muscles, fat, and other soft tissues in the arms, legs, and trunk. The study is testing two medications, ifosfamide and doxorubicin, which are given as a solution through a vein. These medications are used in a sequence to see how well they work in shrinking the tumors before surgery.

The purpose of the study is to evaluate how many patients show a reduction in tumor size when treated with these medications. Participants will receive the treatment over a period of time, and their response to the treatment will be monitored using imaging techniques. The study will also look at the safety of the treatment and how it affects the quality of life of the participants.

Throughout the study, researchers will collect information to understand how the treatment works and identify any markers that might predict how well a patient responds to the therapy. This information could help improve treatment strategies for patients with soft tissue sarcoma in the future.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, organ function, and medical history.

A histological diagnosis of soft tissue sarcoma is required, and the tumor must be measurable according to specific guidelines.

2 initial assessment

An initial assessment is conducted to evaluate the patient’s health status and to collect baseline data.

This includes laboratory tests to ensure adequate organ function and bone marrow reserve.

3 treatment phase 1

The first phase of treatment involves the administration of doxorubicin hydrochloride and ifosfamide.

These medications are given as a solution for injection through intravenous use.

The specific dosage and frequency are determined by the medical team based on individual patient needs.

4 monitoring and evaluation

Throughout the treatment, regular monitoring is conducted to assess the response to the medication.

This includes imaging studies to evaluate the size of the tumor and laboratory tests to monitor organ function.

5 treatment phase 2

The second phase of treatment continues with the administration of the same medications, doxorubicin hydrochloride and ifosfamide.

Adjustments to the treatment plan may be made based on the patient’s response and any side effects experienced.

6 final assessment

A final assessment is conducted to determine the overall response to the treatment.

This includes evaluating the tumor size and any changes in the patient’s health status.

7 follow-up

After the treatment phase, follow-up appointments are scheduled to monitor the patient’s health and any long-term effects of the treatment.

These appointments may include additional imaging studies and laboratory tests.

Who Can Join the Study?

Must be 18 years or older at the time of giving consent to participate.
Must have adequate organ function and bone marrow reserve. This means certain blood tests should show:
- Hemoglobin (a protein in red blood cells) should be 8.0 g/dL or higher.
- Neutrophil count (a type of white blood cell) should be 1.0 x 10⁹/L or higher.
- Platelet count (cells that help with blood clotting) should be 75 x 10⁹/L or higher.
- Total bilirubin (a substance made by the liver) should be 1.5 times the normal limit or lower.
- Creatinine clearance (a measure of kidney function) should be 60 ml/min or higher.
Must test negative for Hepatitis B and C and HIV.
Women who can have children and their partners must use effective birth control during the study and for one year after the last dose of study medication. Women must have a negative pregnancy test before starting the study.
Must have a histological diagnosis (a diagnosis made by examining tissue under a microscope) of a specific type of soft tissue sarcoma. These types include:
- Leiomyosarcoma
- Malignant peripheral nerve sheath tumor
- Undifferentiated pleomorphic sarcoma
- Myxofibrosarcoma
- Synovial sarcoma
- Pleomorphic liposarcoma
- Pleomorphic rhabdomyosarcoma
- Unclassified spindle cell sarcoma
The tumor must be located in the arms, legs, or trunk (the main part of the body).
The primary tumor must be available for a biopsy (a small sample of tissue taken for testing).
Must have a measurable tumor according to specific guidelines (RECIST v1.1).
Must have an ECOG performance status of 0 or 1, which means the patient is fully active or has some symptoms but can carry out light work.

Who Cannot Join the Study?

Patients who do not have a high-grade soft tissue sarcoma in the arms, legs, or trunk wall. A sarcoma is a type of cancer that starts in the body’s soft tissues, like muscles or fat.
Patients who are not within the specified age range for the study. The study is open to certain age groups only.
Patients who are not willing or able to follow the study procedures and requirements.
Patients who have other medical conditions that might interfere with the study or make it unsafe for them to participate.
Patients who are pregnant or breastfeeding, as the study may involve treatments that could affect the baby.
Patients who are participating in another clinical trial at the same time, as this could affect the results of the study.
Patients who have had certain treatments or medications recently that might interfere with the study.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Oslo Universitetssykehus HF	Oslo	Norway

Other Sites

Site Name	City	Country	Status
Hjexu Bitdpl Hp	Bergen	Norway

Trial status

Country	Status	Recruitment Start
Norway	Recruiting	22.09.2020

Trial locations

Investigated drugs:

Ifosfamide is a chemotherapy medication used to treat certain types of cancer. In this trial, it is used as part of a treatment plan for patients with high-grade soft tissue sarcoma. It works by interfering with the growth and spread of cancer cells in the body.

Doxorubicin is another chemotherapy drug used in this trial. It is used to treat various types of cancer, including soft tissue sarcoma. Doxorubicin works by slowing or stopping the growth of cancer cells. In this study, it is used in combination with ifosfamide to enhance the treatment’s effectiveness against the cancer.

Investigated diseases:

Soft tissue sarcoma

High-Grade Soft Tissue Sarcoma – This is a type of cancer that originates in the soft tissues of the body, such as muscles, fat, nerves, and blood vessels. It is characterized by the presence of abnormal cells that grow uncontrollably and can invade nearby tissues. High-grade sarcomas are aggressive and tend to grow and spread more quickly than low-grade sarcomas. They are most commonly found in the extremities and trunk wall. As the disease progresses, it can lead to the formation of a noticeable lump or swelling, and may cause pain or functional impairment depending on its location. The progression of the disease can vary, with some tumors growing rapidly while others may remain stable for a period of time.

Trial ID:

2023-510185-27-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Ifosfamide and Doxorubicin for Patients with High-Grade Soft Tissue Sarcoma in the Limbs and Trunk Wall

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?