RecruitingPhase 3NCT04757337

Comparison of Oral Cyclophosphamide vs Doxorubicin in ≥65 Years Old Advanced or Metastatic Soft Tissue Sarcoma Patients

Randomized Phase III Study of Oral Cyclophosphamide vs Doxorubicin in 65 Years or Older Patients With Advanced or Metastatic Soft Tissue Sarcoma: a UNICANCER/GERICO Multicenter Program


Sponsor

UNICANCER

Enrollment

214 participants

Start Date

Jun 18, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

Most advanced or metastatic soft tissue sarcoma (STS) are unfortunately incurable, making the preservation of the patient's quality of life a major goal, along with prolonging survival. Age is not a criterion for not providing effective treatment, but the goals of treatment change with age and must be integrated into the treatment decision. Elderly patients prioritise a life free of dependency, preservation of their cognitive functions and quality of life related to their state of health. They are therefore reluctant to receive a treatment that does little to improve life expectancy at the cost of significant functional losses. Patients aged 65 years and older account for one third of all patients with STS. In the absence of dedicated recommendations, these elderly patients are currently receiving doxorubicin-based chemotherapy as first-line treatment (as recommended for younger patients), with a substantial risk of toxicity (especially cardiac). In this specific population, previous studies have shown that oral cyclophosphamide seems to have a promising activity, but also a very acceptable toxicity. Thus, the GERICO study aims to compare standard doxorubicin chemotherapy with oral cyclophosphamide for the treatment of elderly patients with STS.


Eligibility

Min Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study compares two chemotherapy options — oral cyclophosphamide and doxorubicin — for older adults with advanced or metastatic soft tissue sarcoma, to see which is more effective and better tolerated in this age group. **You may be eligible if...** - You are 65 years or older - You have been diagnosed with advanced or metastatic soft tissue sarcoma - You are able to give informed consent (either personally or through a trusted representative if physically unable) - You meet specific performance and health criteria **You may NOT be eligible if...** - You are under 65 years old - You have received prior treatment that makes you ineligible - Your overall health prevents you from safely receiving these treatments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGDoxorubicin

6 x 3-week cycles corresponding to a maximal duration of 18 weeks

DRUGCyclophosphamide

Until progression up to 24 months


Locations(1)

Institut Claudius Reagaud-IUCT Oncopôle

Toulouse, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04757337


Related Trials