Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 comprehensive geriatric assessment (CGA) is frequently considered as essential and mandatory for elderly cancer patients. The G8 questionnaire is able to identify patients requiring CGA, with a threshold score of ≤14/17 and with a strong 1-year prognostic value. According to guidelines, the recommended first-line treatment of these patients relies on single agent chemotherapy with anthracyclines (including doxorubicin); however, anthracycline-based treatments have modest performance in patients with metastatic STS with a median progression-free survival of about 4 months and an overall survival of about 12 months. Previous studies have demonstrated promising activity of oral metronomic cyclophosphamide in STS patients and its favorable safety profile. To evaluate this promising activity we designed a phase III, randomized, open-label, multicentric study comparing daily oral cyclophosphamide versus standard 3-week intravenous injection of doxorubicin in 65 years or older patients with advanced or metastatic STS. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04757337
Study type Interventional
Source UNICANCER
Contact Thibaud Valentin, M.D
Phone +33 5 31 15 51 70
Email Valentin.Thibaud@iuct-oncopole.fr
Status Recruiting
Phase Phase 3
Start date June 18, 2021
Completion date April 2026

See also
  Status Clinical Trial Phase
Terminated NCT05043649 - Camsirubicin + Pegfilgrastim to Determine MTD in ASTS Phase 1
Recruiting NCT05146440 - Multicohort Trial of Different Schemes of PM14 in Monotherapy and in Combination With Radiotherapy in Soft Tissue Sarcomas and Other Solid Tumor Phase 1/Phase 2
Recruiting NCT05620693 - Study of NY-ESO-1 TCR-T in Advanced Soft Tissue Sarcoma N/A
Recruiting NCT05809830 - Phase I/II of LB-100 Plus Doxorubicin vs. Doxorubicin Alone in First Line of Advanced Soft Tissue Sarcomas Phase 1/Phase 2
Not yet recruiting NCT06367075 - A Trial of Cadonilimab With Adriamycin in Patients With Advanced Soft Tissue Sarcoma Phase 2
Recruiting NCT04874311 - Bintrafusp Alfa and Doxorubicin Hydrochloride in Treating Patients With Advanced Sarcoma Phase 2
Recruiting NCT05876715 - LINNOVATE: Lurbinectedin, Ipilimumab and Nivolumab for Soft Tissue Sarcoma Phase 1/Phase 2
Recruiting NCT04705818 - Combining Epigenetic And Immune Therapy to Beat Cancer. Phase 2
Terminated NCT05154630 - Study on Tolerability and Pharmacokinetics of TQB2858 Injection in Subjects With Advanced Malignant Tumors Phase 1/Phase 2
Recruiting NCT05099666 - Lurbinectedin + Doxorubicin In Leiomyosarcoma Phase 1/Phase 2
Completed NCT03022448 - Geriatric Assessmen of Elderly "Unsuited" Patients Receiving Trabectedin in First Line Treatment For Advanced Soft Tissue Sarcomas (STS)
Recruiting NCT04204941 - Tazemetostat in Combination With Doxorubicin as Frontline Therapy for Advanced Epithelioid Sarcoma Phase 3
Recruiting NCT05182164 - Combination of Pembrolizumab and Cabozantinib in Patients With Advanced Sarcomas Phase 2
Recruiting NCT05180695 - HDM201 and Pazopanib in Patients With P53 Wild-type Advanced/Metastatic Soft Tissue Sarcomas Phase 1/Phase 2
Terminated NCT04780464 - A 3 Arm Randomized Study on Health-related QoL of Elderly Patients With Advanced Soft Tissue Sarcoma Phase 3