Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04757337
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2021-02-10
Brief Title:
Comparison of Oral Cyclophosphamide vs Doxorubicin in 65 Years Old Advanced or Metastatic Soft Tissue Sarcoma Patients
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
Randomized Phase III Study of Oral Cyclophosphamide vs Doxorubicin in 65 Years or Older Patients With Advanced or Metastatic Soft Tissue Sarcoma a UNICANCERGERICO Multicenter Program
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GERICO14
Brief Summary:
Most advanced or metastatic soft tissue sarcoma STS are unfortunately incurable making the preservation of the patients 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
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
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 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 1417 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-000542-20 | EUDRACT_NUMBER | None | None |