Actively Recruiting
Comparison of Oral Cyclophosphamide vs Doxorubicin in ≥65 Years Old Advanced or Metastatic Soft Tissue Sarcoma Patients
Led by UNICANCER · Updated on 2025-03-25
214
Participants Needed
1
Research Sites
249 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comparison of Oral Cyclophosphamide vs Doxorubicin in ≥65 Years Old Advanced or Metastatic Soft Tissue Sarcoma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent (or consent confirmed by a trusted person if unable)
- Age 65 years or older (at least 50% aged 75 years or older)
- Histologically confirmed soft-tissue sarcoma by RRePS
- Metastatic or locally advanced disease not suitable for curative surgery or radiation
- Disease progression documented within 6 months before randomization
- At least one measurable lesion on CT scan as per RECIST v1.1
- Life expectancy of at least 6 months
- ECOG performance status of 0 to 2
- G8 score greater than 14
- Left ventricular ejection fraction (LVEF) of 55% or higher
- Adequate bone marrow, kidney, and liver function within 7 days before treatment start:
- Absolute neutrophil count ≥1500/mm³
- Platelets ≥100,000/mm³
- Hemoglobin ≥9.0 g/dL
- Serum creatinine ≤2 times upper limit of normal
- Glomerular filtration rate ≥50 ml/min/1.73m²
- AST and ALT ≤2.5 times upper limit of normal (≤5 times if liver involved)
- Total bilirubin ≤1.5 times upper limit of normal
- Alkaline phosphatase ≤2.5 times upper limit of normal (≤5 times if liver involved)
- Serum albumin >25 g/L
- Prothrombin time/INR ≤1.5 times upper limit of normal with stable levels if on anticoagulants
- Male patients agree to use adequate contraception during study and for 6 months after
- Affiliated with a Social Security System or equivalent
- Willing and able to comply with study protocol including visits, treatment, tests, and follow-up
You will not qualify if you...
- Previous systemic treatment for advanced or metastatic sarcoma
- Previous neoadjuvant or adjuvant anthracycline treatment for localized sarcoma
- Soft-tissue sarcoma subtypes: dermatofibrosarcoma protuberans, desmoid tumor, alveolar or embryonal rhabdomyosarcoma, desmoplastic small round cell tumor, Kaposi sarcoma, gastrointestinal stromal tumor, peripheral neuroectodermal tumors
- Primary bone sarcomas including osteosarcoma, Ewing tumor, chondrosarcoma, chordoma
- Symptomatic or known central nervous system metastases
- Known or concurrent malignancy likely to affect life expectancy or recent mediastinal radiotherapy (within 5 years)
- Major surgery, open biopsy, or significant traumatic injury within 28 days before treatment start
- Active cardiovascular disease including congestive heart failure (NYHA class ≥2), unstable or new-onset angina, acute inflammatory heart disease, severe arrhythmia, high bleeding risk, stroke within last 6 months
- Uncontrolled hypertension greater than grade 2
- Ongoing infection grade 2 or higher
- Known HIV infection
- Known chronic hepatitis B or C
- History of organ transplant
- Acute hemorrhagic cystitis, urinary tract obstruction or infection
- Conditions interfering with study conduct or posing unacceptable risk
- Substance abuse or medical issues interfering with participation or evaluation
- Known allergy to study drugs or their ingredients
- Unable to swallow oral medications or malabsorption conditions
- Persons deprived of liberty or under custody/guardianship
- Participation in another therapeutic trial within 30 days before and during the study
- Live attenuated vaccination within 4 weeks before first dose or during study until 6 months after last treatment
- Unable or unwilling to comply with required medical follow-up due to geographic, social, or psychological reasons
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Institut Claudius Reagaud-IUCT Oncopôle
Toulouse, France, 31100
Actively Recruiting
Research Team
T
Thibaud Valentin, M.D
CONTACT
M
Meryem Brihoum
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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