Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06513065
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-25
Brief Title:
Study to Evaluate the Non-inferiority of Low-dose HIPEC Versus High-dose HIPEC in the Treatment of PMP HIPEC-PMP
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single Blinded Randomised Controlled Study to Evaluate the Non-inferiority of HIPEC With Mitomycin C 10 mgm2 for 60 Minutes Versus HIPEC With Mitomycin C 35mgm2 for 90 Minutes in the Treatment of Pseudomyxoma Peritonei From Perforated Epithelial Mucinous Tumours of the Appendix
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HIPEC-PMP
Brief Summary:
The Investigators are researching how to improve the treatment currently available for patients diagnosed with Pseudomyxoma Peritonei PMP This is a rare cancer that usually starts in the appendix and spreads around the abdomen
PMP is usually treated using a type of surgery called Cytoreductive Surgery CRS During the surgery heated chemotherapy will also be used to treat any cancer cells that cannot be seen and may be left behind This is called Hyperthermic Intraperitoneal Chemotherapy HIPEC
This treatment is commonly used in the UK and in Europe however the chemotherapy can be given at two different doses a lower dose over 60 minutes or a higher-dose over 90 minutes
The Investigators want to understand if there is a difference between these two doses The higher dose has been associated with a slightly increased rate of complications but may be better at killing cancer cells and preventing recurrence of cancer In Basingstoke the lower dose over 60 minutes is used and survival results are similar to centres who use the higher dose
Previous studies have shown that both doses are effective at treating PMP but no research has shown which is better for patients The Investigators hope to show that the lower-dose over 60-minutes is as good as the higher-dose over 90-minutes
PMP is usually treated using a type of surgery called Cytoreductive Surgery CRS During the surgery heated chemotherapy will also be used to treat any cancer cells that cannot be seen and may be left behind This is called Hyperthermic Intraperitoneal Chemotherapy HIPEC
This treatment is commonly used in the UK and in Europe however the chemotherapy can be given at two different doses a lower dose over 60 minutes or a higher-dose over 90 minutes
The Investigators want to understand if there is a difference between these two doses The higher dose has been associated with a slightly increased rate of complications but may be better at killing cancer cells and preventing recurrence of cancer In Basingstoke the lower dose over 60 minutes is used and survival results are similar to centres who use the higher dose
Previous studies have shown that both doses are effective at treating PMP but no research has shown which is better for patients The Investigators hope to show that the lower-dose over 60-minutes is as good as the higher-dose over 90-minutes
Detailed Description:
HIPEC-PMP is a randomised non-inferiority phase III trial with two parallel groups designed to assess two doses of mitomycin C MMC for the treatment of pseudomyxoma peritonei The trial is to be carried out in a single specialist centre
The low and high doses within the trial are used routinely across the world but to date they have not been compared directly As the lead site use low dose MMC the trial has been designed to assess whether this has comparable performance to high dose with respect to clinical outcomes primarily disease-free survival DFS hence the non-inferiority design The trial uses a Bayesian design to incorporate existing information on the two treatments given they are used routinely and various studies have reported DFS rates in cohort studies The design allows for discounting the prior information through data-driven weighting of different prior distributions if the observed data is observed to be markedly different to prior data
Cytoreductive surgery CRS and hyperthermic intraperitoneal chemotherapy HIPEC represent the standard of care for Pseudomyxoma Peritonei PMP of appendiceal origin Although Mitomycin C is used as standard of care HIPEC treatment the optimal dose of Mitomycin C MMC and duration of HIPEC following cytoreductive surgery remains to be defined
This study therefore aims to evaluate the non-inferiority of HIPEC with mitomycin C 10 mgm2 for 60 minutes versus HIEPC with mitomycin C 35 mgm2 for 90 minutes There is a small risk of higher toxicity with 35 mgm2 of Mitomycin C however Kuijpers et al found that morbidity was tolerable and convincing survival
There is limited evidence on the quality of life in patients with PMP therefore assessing quality of life will provide information that could be used to improve patient care and well-being In addition furthering understanding of the genetics of the disease could improve prognostication and targeted treatments for patient benefit could be explored and will therefore be investigated in this study Translational blood samples including tissue normal primary and metastatic serum plasma DNA RNA and buffy coat will be collected for genetic analysis
The low and high doses within the trial are used routinely across the world but to date they have not been compared directly As the lead site use low dose MMC the trial has been designed to assess whether this has comparable performance to high dose with respect to clinical outcomes primarily disease-free survival DFS hence the non-inferiority design The trial uses a Bayesian design to incorporate existing information on the two treatments given they are used routinely and various studies have reported DFS rates in cohort studies The design allows for discounting the prior information through data-driven weighting of different prior distributions if the observed data is observed to be markedly different to prior data
Cytoreductive surgery CRS and hyperthermic intraperitoneal chemotherapy HIPEC represent the standard of care for Pseudomyxoma Peritonei PMP of appendiceal origin Although Mitomycin C is used as standard of care HIPEC treatment the optimal dose of Mitomycin C MMC and duration of HIPEC following cytoreductive surgery remains to be defined
This study therefore aims to evaluate the non-inferiority of HIPEC with mitomycin C 10 mgm2 for 60 minutes versus HIEPC with mitomycin C 35 mgm2 for 90 minutes There is a small risk of higher toxicity with 35 mgm2 of Mitomycin C however Kuijpers et al found that morbidity was tolerable and convincing survival
There is limited evidence on the quality of life in patients with PMP therefore assessing quality of life will provide information that could be used to improve patient care and well-being In addition furthering understanding of the genetics of the disease could improve prognostication and targeted treatments for patient benefit could be explored and will therefore be investigated in this study Translational blood samples including tissue normal primary and metastatic serum plasma DNA RNA and buffy coat will be collected for genetic analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None