Ignite Creation Date:
2024-05-06 @ 7:19 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05963334
Status:
COMPLETED
Last Update Posted:
2023-07-27
First Post:
2023-07-10
Brief Title:
Comparison of Weekly Versus Every Three Weeks of Carboplatin Plus Paclitaxel in Patients With Advanced Epithelial Ovarian Cancer
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
A Non-randomized Control Study Comparing Weekly Versus Every Three Weeks of Carboplatin Plus Paclitaxel in Patients With Advanced Epithelial Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2023-07
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:
None
Brief Summary:
The aim of the current study is to compare weekly versus three-week collective of carboplatinpaclitaxel in advanced epithelial ovarian cancer The authors hypothesis was to study and correlate routine laboratory tests clinical biomarkers and quality of life questionnaires between weekly and three-week standard carboplatin regimens in order to reveal any possible superiority for the weekly study arm
Detailed Description:
Ovarian cancer as the fifth leading cause of death in women worldwide Since most women suffer asymptomatic manifestations or nonspecific symptoms subsequent diagnosis is very tricky and late most of the time Carboplatinpaclitaxel has been among the first line options for treatment of ovarian cancer for decades however account for a great of deal of adverse effects affecting patient safety These side effects are dose related whereas dose of carboplatin is calculated individually for each patient using the Calvert equation focusing on renal functions at baseline Carboplatin adverse effects are believed to mainly affect the kidneys hematological system and may cause neurotoxicity thus exhibit quality of life deteriorations
The study purpose was to investigate a triple correlation between 3 different aspects comparing the weekly dose versus the three-week dense dose of carboplatinpaclitaxel in treating advanced epithelial ovarian cancer
Points of comparison
1 Routine laboratory parameters in an attempt to identify the possible adverse effects accounted to each regimen focusing on hematological renal hepatic and tumor marker panels
2 Additional biomarkers including cystatin-C neutrophil gelatinase associated lipocalin hepcidin kidney injury marker-1 and interleukin-18 assessing the probable incidence of acute kidney injury and anemia
3 Quality of life analyzed by comparing functional assessment of cancer therapy-ovarian and functional assessment of cancer therapygynecologic oncology group-neurotoxicity surveys between both groups
The study encouraged the patient right to be involved and consent to the assigned protocol
The correlation between all three aspects studied as of routine lab work toxicity biomarkers and quality of life besides the economic burden aim to provide a decent patient tailored treatment regimen balancing efficacy and safety
The study purpose was to investigate a triple correlation between 3 different aspects comparing the weekly dose versus the three-week dense dose of carboplatinpaclitaxel in treating advanced epithelial ovarian cancer
Points of comparison
1 Routine laboratory parameters in an attempt to identify the possible adverse effects accounted to each regimen focusing on hematological renal hepatic and tumor marker panels
2 Additional biomarkers including cystatin-C neutrophil gelatinase associated lipocalin hepcidin kidney injury marker-1 and interleukin-18 assessing the probable incidence of acute kidney injury and anemia
3 Quality of life analyzed by comparing functional assessment of cancer therapy-ovarian and functional assessment of cancer therapygynecologic oncology group-neurotoxicity surveys between both groups
The study encouraged the patient right to be involved and consent to the assigned protocol
The correlation between all three aspects studied as of routine lab work toxicity biomarkers and quality of life besides the economic burden aim to provide a decent patient tailored treatment regimen balancing efficacy and safety
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?:
False
Is an FDA AA801 Violation?:
None