Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00426257
Status:
COMPLETED
Last Update Posted:
2018-08-24
First Post:
2007-01-23
Brief Title:
Secondary Debulking Surgery - Hyperthermic Intraperitoneal Chemotherapy in Stage III Ovarian Cancer
Sponsor:
The Netherlands Cancer Institute
Organization:
The Netherlands Cancer Institute
Study Overview
Official Title:
Phase III Randomised Clinical Trial for Stage III Ovarian Carcinoma Randomising Between Secondary Debulking Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy
Status:
COMPLETED
Status Verified Date:
2017-08
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:
None
Brief Summary:
This study evaluates the efficacy and safety of the addition of hyperthermic intraperitoneal chemotherapy to secondary debulking surgery in stage III ovarian cancer
Detailed Description:
Rationale Ovarian cancer is the second most common gynaecologic cancer in the Netherlands preceded by endometrial cancer It is however the leading cause of death among women with gynaecologic malignancies with an annual mortality rate of 9 per 100000 The majority of the patients are diagnosed with a high stage ovarian carcinoma due to the fact that symptoms occur at a late stage of the disease and screening methods for ovarian cancer are suboptimal Optimal treatment consists of a combination of chemotherapy and debulking surgery Despite the appearance of localized disease and the absence of obvious residual tumour following primary treatment the majority of patients 80 will have persistent disease or will develop recurrent disease Additional strategies are warranted to reduce the recurrence rate and increase disease free survival and overall survival in this group of patients
The concept of administering intraperitoneal chemotherapy is based on the ideas on peritoneal dialysis Intraperitoneal drug therapy is designed to maximize drug delivery to the tumour with generally acceptable systemic side effects associated with IV administration of the drug This strategy is especially attractive for treatment of ovarian carcinoma which remains largely restricted to the abdominal cavity for most of its natural history So far 3 randomised controlled trials have shown an overall and progression-free survival benefit when cisplatin is administered postoperatively by the IP route in patients with stage III optimally resected disease These studies however found that the majority of patients did not complete all planned 6 cycles due to catheter related problems An alternative way of administering chemotherapy intra abdominally whilst bypassing the use of a catheter intra- abdominally is provided by perfusion of the abdomen during surgery under hyperthermic conditions This study compares the interval debulking plus or minus the perfusion of the abdomen with chemotherapy under hyperthermic conditions during surgery OVHIPEC
Objective The primary objectives of this study are comparing the duration of recurrence free survival following completion of treatment between the 2 study arms
Secondary objectives of this study involve toxicity and morbidity quality of life tumour response following treatment and overall survival of the study arm compared to the standard arm
Study design Phase III randomised trial Study population Patients diagnosed with stage III ovarian carcinoma peritoneal cell carcinoma or tuba carcinoma who are eligible for interval debulking surgery either following primary chemotherapy or following incomplete primary debulking and chemotherapy Age between 18 - 76 yr old
Intervention One group undergoes interval debulking with hyperthermic perfusion of the abdominal cavity with cisplatin 100 mgm2 at the end of surgery The other group is treated by interval debulking only
Main study parametersendpoints Recurrence free survival Nature and extent of the burden and risks associated with participation benefit and group relatedness Participants of the study will be asked to fill in quality of life questionnaires 12 times in 2 year Blood samples will be taken following written informed consent before treatment during surgery and during follow-up visits for marker studies and proteomics studies 10 times during 2 year For patients participating in the pharmacokinetic studies 20 2 tissue samples will be taken from the abdominal cavity during surgery and blood samples will be taken 6 times during and after surgery
During follow-up 3 monthly visits will be scheduled in the first 2 years and 6-monthly visits during year 3-5 During these follow-up visits routine physical exam including pelvic exam and vaginal ultrasound optional is performed CT-scans will be performed in the first 2 years before randomisation and 4 times at follow-up
Risks of participating in this trial are related to the abdominal perfusion of cisplatin This can cause systemic effects such as nephrotoxicity bone marrow toxicity neurotoxicity and longer hospital stay It can also increase the chance on bowel perforation of a bowel anastomoses resulting in a longer hospital stay and possibly surgical intervention To prevent systemic side effects of intra-abdominally administered cisplatin sodium thiosulphate is administered intravenously during surgery
The concept of administering intraperitoneal chemotherapy is based on the ideas on peritoneal dialysis Intraperitoneal drug therapy is designed to maximize drug delivery to the tumour with generally acceptable systemic side effects associated with IV administration of the drug This strategy is especially attractive for treatment of ovarian carcinoma which remains largely restricted to the abdominal cavity for most of its natural history So far 3 randomised controlled trials have shown an overall and progression-free survival benefit when cisplatin is administered postoperatively by the IP route in patients with stage III optimally resected disease These studies however found that the majority of patients did not complete all planned 6 cycles due to catheter related problems An alternative way of administering chemotherapy intra abdominally whilst bypassing the use of a catheter intra- abdominally is provided by perfusion of the abdomen during surgery under hyperthermic conditions This study compares the interval debulking plus or minus the perfusion of the abdomen with chemotherapy under hyperthermic conditions during surgery OVHIPEC
Objective The primary objectives of this study are comparing the duration of recurrence free survival following completion of treatment between the 2 study arms
Secondary objectives of this study involve toxicity and morbidity quality of life tumour response following treatment and overall survival of the study arm compared to the standard arm
Study design Phase III randomised trial Study population Patients diagnosed with stage III ovarian carcinoma peritoneal cell carcinoma or tuba carcinoma who are eligible for interval debulking surgery either following primary chemotherapy or following incomplete primary debulking and chemotherapy Age between 18 - 76 yr old
Intervention One group undergoes interval debulking with hyperthermic perfusion of the abdominal cavity with cisplatin 100 mgm2 at the end of surgery The other group is treated by interval debulking only
Main study parametersendpoints Recurrence free survival Nature and extent of the burden and risks associated with participation benefit and group relatedness Participants of the study will be asked to fill in quality of life questionnaires 12 times in 2 year Blood samples will be taken following written informed consent before treatment during surgery and during follow-up visits for marker studies and proteomics studies 10 times during 2 year For patients participating in the pharmacokinetic studies 20 2 tissue samples will be taken from the abdominal cavity during surgery and blood samples will be taken 6 times during and after surgery
During follow-up 3 monthly visits will be scheduled in the first 2 years and 6-monthly visits during year 3-5 During these follow-up visits routine physical exam including pelvic exam and vaginal ultrasound optional is performed CT-scans will be performed in the first 2 years before randomisation and 4 times at follow-up
Risks of participating in this trial are related to the abdominal perfusion of cisplatin This can cause systemic effects such as nephrotoxicity bone marrow toxicity neurotoxicity and longer hospital stay It can also increase the chance on bowel perforation of a bowel anastomoses resulting in a longer hospital stay and possibly surgical intervention To prevent systemic side effects of intra-abdominally administered cisplatin sodium thiosulphate is administered intravenously during surgery
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006-003466-34 | EUDRACT_NUMBER | None | None |
| 2006-16 | OTHER_GRANT | Commissie Klinische Studies | None |