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 study about?

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.

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 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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Oncopole Claudius Regaud	Toulouse	France
Centre Jean Perrin	Clermont Ferrand	France
Institut De Cancerologie De Lorraine	Vandoeuvre Les Nancy	France

Other Sites

Site Name	City	Country
Hopital Tenon	Paris	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Institut Godinot	Reims	France
Hopital Beaujon	Clichy	France
Centre Francois Baclesse	Caen	France
Ckcxut Lkmg Bbivuv	Lyon	France
Ainfdacrrr Peavoajg Hsotxbnr Dw Mcqqfbyer	Marseille	France
Bgpxkiyi Ubfszgrxnl Haruixsa Czhruu	Besançon	France
Cynogo Hbytndxhthu Rjxwxkeg Ucyhnedfpjpzz Di Tvwba	Tours	France
Insbnyis du Csrmijgszyhw Hmqtvleuosh Uvqzpwmopdmlc dm Syjwn Epkvfau (cnokuxn	Saint Priest En Jarez	France
Ioenxfmq Pgemmnbsvgyswea Cubrgu Chutru	Marseille	France
Cqcidm Oevaz Lnhjmtt	Lille	France
Iwrnnddr Ciiuv	Paris	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	04.06.2021

Trial locations

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.

Investigated diseases:

Soft tissue sarcoma

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 ID:

2024-510653-10-00

Protocol code:

UC-0103/1802

NCT ID:

NCT04757337

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?