Ignite Creation Date:
2024-05-06 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05841420
Status:
RECRUITING
Last Update Posted:
2023-07-27
First Post:
2023-03-16
Brief Title:
Gemcitabine Versus Reduced-dose Combination Chemotherapy in Fragile Patients With Non-resectable Pancreatic Cancer
Sponsor:
Morten Ladekarl
Organization:
Aalborg University Hospital
Study Overview
Official Title:
A Randomized Phase II Study of Gemcitabine Versus Reduced-dose Combination Chemotherapy in Fragile Patients With Non-resectable Pancreatic Cancer
Status:
RECRUITING
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 study is to compare the efficacy and toxicity of full-dose Gemcitabine and reduced-dose combination chemotherapy in patients with non-resectable pancreatic cancer who are unfit for full-dose combination chemotherapy
The patients will be equally randomized to arm A or arm B
Arm A Full-dose single agent treatment with Gemcitabine 1000 mgm2 weekly on days 1 8and 15 every 4 weeks
Arm B Reduced-dose 80 combination-treatment with Gemcitabine plus Nab-Paclitaxel Gemcitabine 800 mgm2 plus Nab-Paclitaxel 100 mgm2 on day 1 8 and 15 every 4 weeks
Progression-free survival overall survival and response rate will be estimated for each group as well as toxicity and quality of life will be prospectively registered
The patients will be equally randomized to arm A or arm B
Arm A Full-dose single agent treatment with Gemcitabine 1000 mgm2 weekly on days 1 8and 15 every 4 weeks
Arm B Reduced-dose 80 combination-treatment with Gemcitabine plus Nab-Paclitaxel Gemcitabine 800 mgm2 plus Nab-Paclitaxel 100 mgm2 on day 1 8 and 15 every 4 weeks
Progression-free survival overall survival and response rate will be estimated for each group as well as toxicity and quality of life will be prospectively registered
Detailed Description:
According to guidelines the recommended treatment for patients with non-resectable pancreatic cancer PC is combination chemotherapy whereas old andor fragile patients can be offered Gemcitabine monotherapy if they are fit for treatment Phase III trials show improved effect of combination chemotherapy compared to Gemcitabine but these trials were restricted to fit patients younger than 75 years of age as full-dose combination chemotherapy is more toxic
Studies in colorectal cancer and a post-hoc analysis of Gemcitabine plus Nab-Paclitaxel in PC suggest that reduced-dose of combination chemotherapy may be more efficient in terms of progression-free survival and less toxic as compared to monotherapy in elderly andor frail patients but reduced start-dosing of GemNab is not currently labelled
Moreover a recent Danish register-based study showed that more use of combination chemotherapy at oncological departments was associated with improved outcome of patients with PC
Elderly and frail patients with PC are in great need of better treatment results Hence a comparative study of reduced-dose combination chemotherapy is warranted and may be practice changing
The aim of the study is to compare the efficacy and toxicity of full-dose Gemcitabine and reduced-dose combination chemotherapy in patients with non-resectable PC who are unfit for full-dose combination chemotherapy
The study is a national multicenter prospective randomized phase II trial endorsed by the Danish Pancreas Cancer Group DPCG 98 patients with non-resectable PC unfit for full-dose combination chemotherapy but eligible for first-line chemotherapy will be included
The patients will be equally randomized to arm A or arm B
Arm A Full-dose single agent treatment with Gemcitabine 1000 mgm2 weekly on days 1 8 and 15 every 4 weeks
Arm B Reduced-dose 80 combination-treatment with GemNab Gemcitabine 800 mgm2 plus Nab-Paclitaxel 100 mgm2 on day 1 8 and 15 every 4 weeks
Progression-free survival overall survival and response rate will be estimated for each group as well as toxicity and quality of life will be prospectively registered
Studies in colorectal cancer and a post-hoc analysis of Gemcitabine plus Nab-Paclitaxel in PC suggest that reduced-dose of combination chemotherapy may be more efficient in terms of progression-free survival and less toxic as compared to monotherapy in elderly andor frail patients but reduced start-dosing of GemNab is not currently labelled
Moreover a recent Danish register-based study showed that more use of combination chemotherapy at oncological departments was associated with improved outcome of patients with PC
Elderly and frail patients with PC are in great need of better treatment results Hence a comparative study of reduced-dose combination chemotherapy is warranted and may be practice changing
The aim of the study is to compare the efficacy and toxicity of full-dose Gemcitabine and reduced-dose combination chemotherapy in patients with non-resectable PC who are unfit for full-dose combination chemotherapy
The study is a national multicenter prospective randomized phase II trial endorsed by the Danish Pancreas Cancer Group DPCG 98 patients with non-resectable PC unfit for full-dose combination chemotherapy but eligible for first-line chemotherapy will be included
The patients will be equally randomized to arm A or arm B
Arm A Full-dose single agent treatment with Gemcitabine 1000 mgm2 weekly on days 1 8 and 15 every 4 weeks
Arm B Reduced-dose 80 combination-treatment with GemNab Gemcitabine 800 mgm2 plus Nab-Paclitaxel 100 mgm2 on day 1 8 and 15 every 4 weeks
Progression-free survival overall survival and response rate will be estimated for each group as well as toxicity and quality of life will be prospectively registered
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