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Comparison of Cyclophosphamide and Doxorubicin for Treatment of Advanced or Metastatic Soft Tissue Sarcoma in Patients Age 65 and Older

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients aged 65 and older who have advanced or metastatic soft tissue sarcoma, which is a type of cancer that develops in soft tissues like muscles, tendons, and fat. The research compares two different cancer treatments: cyclophosphamide taken by mouth and doxorubicin given through an intravenous line. The study aims to determine if cyclophosphamide leads to better outcomes compared to doxorubicin in elderly patients with this type of cancer.

During the study, patients will receive either cyclophosphamide tablets or doxorubicin infusions. Some patients may also receive additional medications including filgrastim (a drug that helps the body produce white blood cells) and dexrazoxane hydrochloride (a medication that helps protect the heart from potential side effects of doxorubicin). The treatment will continue until the cancer progresses or side effects become too severe.

Throughout the treatment period, doctors will monitor patients' overall health, cancer progression, and quality of life. They will perform regular medical examinations and tests to check how well the treatment is working and to watch for any side effects. Special attention will be given to elderly patients' specific health needs and their ability to perform daily activities.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Your health condition will be evaluated to confirm advanced or metastatic soft tissue sarcoma

    Medical tests will be performed, including heart function assessment (LVEF test), blood tests, and imaging scans

    Your overall health status and ability to perform daily activities will be evaluated using specific assessment tools

  2. Step 2

    Treatment assignment

    You will be randomly assigned to one of two treatment groups:

    Group 1: Doxorubicin given through intravenous infusion

    Group 2: Cyclophosphamide taken orally

    If assigned to Group 1, you will also receive dexrazoxane hydrochloride through intravenous infusion to protect heart function

  3. Step 3

    Treatment period

    Regular medical examinations will be conducted to monitor your health status

    Imaging scans will be performed to evaluate treatment response

    Blood tests will be conducted to monitor your body's response to treatment

    You will complete quality of life questionnaires during the treatment period

    If you are in Group 2, you will need to maintain a diary to track medication intake

  4. Step 4

    Health monitoring

    Your health status will be regularly assessed using specific tests for older adults

    These assessments include evaluation of daily activities, mobility, nutrition status, and cognitive function

    Any side effects will be monitored and recorded according to standardized criteria

  5. Step 5

    Follow-up period

    After completing treatment, regular follow-up visits will be scheduled

    Your health status and disease progression will continue to be monitored

    Quality of life assessments will continue during the follow-up period

Who can join the trial?

17 criteria

  • Age 65 years or older (at least 50% of participants must be 75 years or older)
  • Must have confirmed soft-tissue sarcoma (a type of cancer that develops in soft tissues)
  • Cancer must be advanced or spread to other parts of the body (metastatic) and not suitable for surgery or radiation treatment with the goal of cure
  • Must have evidence that the disease has progressed in the last 6 months
  • Must have at least one measurable tumor that can be seen on CT scan
  • Must have good heart function with a heart ejection fraction of 55% or higher (measure of heart's pumping ability)
  • Must have adequate blood test results showing:
    • Good blood cell counts
    • Normal kidney function
    • Normal liver function
    • Normal blood clotting
    • Must be able to perform daily activities with minimal assistance (ECOG performance status of 2 or better)
    • Life expectancy of at least 6 months
    • Must be willing to use effective birth control during the study and for 6 months after (for male patients)
    • Must be able to follow the study schedule, including all visits and tests
    • Must be covered by Social Security or equivalent insurance
    • Must be able and willing to sign an informed consent form
    • Must be suitable to receive doxorubicin (a type of chemotherapy medication) as determined by the doctor

Who cannot join the trial?

11 criteria

  • Age below 65 years old
  • Having any type of cancer other than soft tissue sarcoma (a type of cancer that develops in soft tissues like muscles, fat, or blood vessels)
  • Not having advanced or metastatic disease (cancer that has spread to other parts of the body)
  • Previous treatment with cyclophosphamide (a chemotherapy medication) or doxorubicin (another type of chemotherapy medication)
  • Severe heart problems that would make chemotherapy unsafe
  • Severe kidney or liver problems that would interfere with treatment
  • Pregnancy or breastfeeding
  • Active serious infections
  • Other serious medical conditions that could interfere with study participation
  • Inability to take oral medications
  • Participation in other clinical trials within the past 30 days
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Investigated drugs

  • Cyclophosphamide

    is an oral chemotherapy medication used to treat various types of cancer. In this trial, it's being studied as a treatment for soft tissue sarcoma in elderly patients. It works by slowing or stopping cancer cell growth.

  • Doxorubicin

    is a chemotherapy medication that is used to treat many different types of cancer, including soft tissue sarcoma. It belongs to a class of drugs called anthracyclines and works by interfering with cancer cell growth and spread throughout the body.

What is already known about the treatment

  • Cyclophosphamide

    An oral chemotherapy medication belonging to the alkylating agents class that works by interfering with cancer cell DNA replication and division. This medication is commonly used in treating various types of cancer, including soft tissue sarcomas, and is particularly studied in elderly patients due to its convenient oral administration and manageable side effect profile. The drug functions by forming cross-links in DNA strands, preventing cancer cells from multiplying effectively.

  • Doxorubicin

    An intravenous chemotherapy medication from the anthracycline class that is considered a standard treatment for soft tissue sarcomas. This medication works by inserting itself into cancer cell DNA and inhibiting an enzyme called topoisomerase II, which is essential for cell division and growth. It has been extensively studied and used in oncology for decades, particularly known for its effectiveness in treating various types of sarcomas, though careful monitoring is required due to its potential cardiac effects.

Investigated diseases

Soft Tissue Sarcoma - A group of cancers that develop in soft tissues such as muscles, tendons, fat, blood vessels, and nerves. The disease begins when abnormal cells start growing in these soft tissues, forming tumors that can appear anywhere in the body. In advanced stages, the cancer spreads beyond its original location to other parts of the body (metastasis). The condition typically starts as a painless lump that grows over time. Soft tissue sarcomas can vary in their growth rate and behavior depending on their specific type.
Trial detailsLast updated 7 Oct 2026
Age65+ yearsPhasePhase IIITrial ID2024-510653-10-00Protocol codeUC-0103/1802Estimated enrolment214 patientsSponsorUnicancer

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