Status:
RECRUITING
Comparison of Oral Cyclophosphamide vs Doxorubicin in ≥65 Years Old Advanced or Metastatic Soft Tissue Sarcoma Patients
Lead Sponsor:
UNICANCER
Conditions:
Advanced Soft-tissue Sarcoma
Metastatic Soft-tissue Sarcoma
Eligibility:
All Genders
65+ years
Phase:
PHASE3
Brief 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 ...
Detailed Description
Co-morbidities increase in number and severity with age, competing with cancer prognosis and making prioritizing medical issues necessary. Individualization of cancer treatment by integrating a compre...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patient must have signed a written informed consent form prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trust person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent
- Age ≥65 years (inclusions will be managed to ensure that at least 50% of the randomized patients are ≥75 years old)
- Diagnosis of soft-tissue sarcoma histologically confirmed by Réseau de Référence en Pathologie des Sarcomes et des Viscères (RRePS)
- Metastatic or locally advanced disease not amenable to surgery, radiation, or combined modality treatment with curative intent. Palliative radiation therapy is permitted only if direct on nontarget lesion
- Documentation of disease progression within the last 6 months before randomization
- Measurable disease, defined as at least 1 unidimensionally measurable lesion on a CT-scan as defined by response evaluation criteria in solid tumors version 1.1 (RECIST v1.1)
- Life expectancy of at least 6 months
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- G8 score \>14
- Left ventricular ejection fraction (LVEF) value by echocardiogram or Multiple gated acquisition scanning (MUGA) ≥55%
- Adequate bone marrow, renal, and hepatic function, as evidenced by the following within 7 days of study treatment initiation:
- Absolute neutrophil count (ANC) ≥1,500/mm³
- Platelets ≥100,000/mm³
- Hemoglobin ≥9.0 g/dL
- Serum creatinine ≤2 x upper limit of normal (ULN)
- Glomerular filtration rate (GFR) ≥50 ml/min/1.73m² (calculated with MDRD)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x ULN (≤5.0 × ULN for patients with liver involvement of their cancer )
- Total bilirubin ≤1.5 X ULN
- Alkaline phosphatase ≤2.5 x ULN (≤5 x ULN with liver involvement of their cancer)
- serum albumin \>25 g/L
- Prothrombin time (PT)/International normalized ratio (INR) ≤1.5 x ULN Patients who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists. Close monitoring of at least weekly evaluations will be performed until PT/INR is stable based on a measurement that is pre-dose as defined by the local standard of care
- Male patients must agree to use adequate contraception for the duration of trial participation and up to 6 months after completing treatment/therapy. Adequate contraception is defined as any medically recommended method (or combination of methods) as per standard of care
- Patients must be affiliated to a Social Security System (or equivalent)
- Patient is willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests and other study procedures including follow-up
- Exclusion Criteria:
- Previous systemic treatment for advance or metastatic sarcoma
- Previous neoadjuvant or adjuvant anthracycline treatment for localized sarcoma
- Soft-tissue sarcoma with the following histological subtypes: dermatofibrosarcoma protuberans, desmoid tumor, alveolar or embryonal rhabdomyosarcoma, Desmoplastic small round cell tumor, Kaposi Sarcoma, Gastro-Intestinal stromal tumor, Peripheral neuroectodermal tumors
- Primary bone sarcoma (including osteosarcoma, Ewing tumor, chondrosarcoma, and chordoma)
- Symptomatic or known central nervous system (CNS) metastases
- Known history of or concomitant malignancy likely to affect life expectancy in the judgment of the investigator and history of radiotherapy mediastinal in the last five years
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before Day 1 of treatment
- Active cardio vascular disease including any of the following: Congestive heart failure (New York Heart Association (NYHA) ≥Class 2), unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months), acute inflammatory cardiopathy, severe arrythmia, high risk of bleeding, cerebrovascular accident within the last 6 months
- Uncontrolled grade \>2 hypertension. (Systolic blood pressure ≥160 mmHg or diastolic pressure ≥100 mmHg despite optimal medical management)
- Ongoing infection ≥Grade 2 according to NCI Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)
- Known history of human immunodeficiency virus (HIV) infection
- Known history of chronic hepatitis B or C
- History of organ allograft
- Pre-existing acute hemorrhagic cystitis, urinary tract obstruction, acute urinary tract infection
- Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
- Substance abuse, medical condition, that may interfere with the patient's participation in the study or evaluation of the study results
- Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation
- Inability to swallow oral medications, any malabsorption condition.
- Persons deprived of their liberty or under protective custody or guardianship
- Participation in another therapeutic trial within the 30 days prior to randomization and during the study
- Patients having received live attenuated vaccine therapy used for prevention of diseases as influenza, chickenpox, zoster, measles, mumps, rubella, tuberculosis, rotavirus or yellow fever within 4 weeks of the first dose of study drug. These vaccinations are not permitted during the study up to 6 months after the last treatment
- Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons
Exclusion
Key Trial Info
Start Date :
June 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT04757337
Start Date
June 18 2021
End Date
April 1 2026
Last Update
March 25 2025
Active Locations (1)
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1
Institut Claudius Reagaud-IUCT Oncopôle
Toulouse, France, 31100