Ignite Creation Date:
2024-07-17 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06476184
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-05
Brief Title:
Utility of Adjusting Chemotherapy Dose Dosing Schedule with the SALVage Weekly Dose-dense Regimen in Patients with Poor Prognostic OVARian Cancers Based on the Tumor Unfavorable Primary Chemosensitivity and Incomplete Debulking Surgery
Sponsor:
ARCAGY GINECO GROUP
Organization:
ARCAGY GINECO GROUP
Study Overview
Official Title:
A Pragmatic Randomized Phase III Trial to Assess the Utility of Adjusting Chemotherapy Dose Dosing Schedule with the SALVage Weekly Dose-dense Regimen in Patients with Poor Prognostic OVARian Cancers Based on the Tumor Unfavorable Primary Chemosensitivity and Incomplete Debulking Surgery
Status:
RECRUITING
Status Verified Date:
2024-08
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:
SALVOVAR
Brief Summary:
SALVOVAR will be a pragmatic open-label multicenter randomized phase III trial ratio 11 comparing the efficacy of the salvage weekly dose-dense regimen with those of the continuation of the standard regimen
Detailed Description:
SALVOVAR is a pragmatic open-label multicenter randomized phase III trial ratio 11 comparing the efficacy of the salvage weekly dose-dense regimen with those of the continuation of the same standard regimen as given during neo-adjuvant period The randomization will be stratified on the main clinical prognostic factors assumed to impact the efficacy of the assessed arms and the overall survival
1 Bevacizumab planned administration Yes vs No
2 BRCA mutation planned administration Yes vs NoUnknown
3 KELIMTM strate within unfavorable KELIM subgroup very unfavorable 07 vs moderately unfavorable 07-10
The trial will be pragmatic as it aims at confirming the superiority of the adjusted chemotherapy compared to the continuation of the standard chemotherapy in routine clinical practice in a population of ovarian cancer patients close to the real-life clinical activity with few selection criteria
1 Bevacizumab planned administration Yes vs No
2 BRCA mutation planned administration Yes vs NoUnknown
3 KELIMTM strate within unfavorable KELIM subgroup very unfavorable 07 vs moderately unfavorable 07-10
The trial will be pragmatic as it aims at confirming the superiority of the adjusted chemotherapy compared to the continuation of the standard chemotherapy in routine clinical practice in a population of ovarian cancer patients close to the real-life clinical activity with few selection criteria
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 |
|---|---|---|---|
| RECF-005636 | OTHER | None | None |