OncoMatch/Clinical Trials/NCT04757337
Comparison of Oral Cyclophosphamide vs Doxorubicin in ≥65 Years Old Advanced or Metastatic Soft Tissue Sarcoma Patients
Is NCT04757337 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Doxorubicin and Cyclophosphamide for advanced soft-tissue sarcoma.
Treatment: Doxorubicin · Cyclophosphamide — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Sarcoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: systemic treatment
Previous systemic treatment for advance or metastatic sarcoma
Cannot have received: anthracycline
Exception: neoadjuvant or adjuvant setting for localized sarcoma
Previous neoadjuvant or adjuvant anthracycline treatment for localized sarcoma
Lab requirements
Blood counts
ANC ≥1,500/mm³; platelets ≥100,000/mm³; hemoglobin ≥9.0 g/dL
Kidney function
Serum creatinine ≤2 x ULN; GFR ≥50 ml/min/1.73m² (calculated with MDRD)
Liver function
AST and ALT ≤2.5 x ULN (≤5.0 × ULN for patients with liver involvement); total bilirubin ≤1.5 X ULN; alkaline phosphatase ≤2.5 x ULN (≤5 x ULN with liver involvement); serum albumin >25 g/L
Cardiac function
Left ventricular ejection fraction (LVEF) by echocardiogram or MUGA ≥55%
Adequate bone marrow, renal, and hepatic function, as evidenced by the following within 7 days of study treatment initiation: ... Left ventricular ejection fraction (LVEF) value by echocardiogram or Multiple gated acquisition scanning (MUGA) ≥55%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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