This study has been transitioned to CTIS with ID 2023-509049-11-00 check the CTIS register for the current data. The primary objective of this study is to evaluate the effect of HIPEC on overall survival when added to primary cytoreductive surgery…
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is overall survival, defined as the time from
randomization to the date of death from any cause. For subjects that are alive,
their survival time will be censored at the date of last contact (*last known
alive date*). Overall survival will be censored for subjects at the date of
randomization if they were randomized but had no follow-up.
Secondary outcome
In addition, we will also investigate whether HIPEC influences disease-free
survival, the time until the next treatment after the first recurrence, the
side effects and quality of life. We will also investigate whether the
treatment is cost effective. We will also do additional biomarker research of
mutations in the tissue and blood.
Background summary
More than 75% of patients with ovarian cancer are diagnosed with an advanced
disease that has spread beyond the ovaries to the peritoneal surface. Optimal
treatment for advanced disease includes cytoreductive surgery (CRS) followed by
six cycles of intravenous (IV) chemotherapy with carboplatin and paclitaxel or
interval CRS after three cycles of chemotherapy. The 5-year survival of
patients with FIGO stage IIb-IV disease is 20-60%. The chance of recurrent
disease within 2 years is 80%. In order to reduce the recurrence rates,
additional strategies for these patients have been indicated. The OVHIPEC-1
study shows that the addition of hyperthermic intraperitoneal chemotherapy
(HIPEC) to interval-cytoreductive surgery significantly improves
recurrence-free and overall survival for patients with stage III epithelial
ovarian cancer. For patients with stage III epithelial ovarian cancer, for
which primary CRS seems feasible, it is still uncertain whether HIPEC has a
similar benefit.
Study objective
This study has been transitioned to CTIS with ID 2023-509049-11-00 check the CTIS register for the current data.
The primary objective of this study is to evaluate the effect of HIPEC on
overall survival when added to primary cytoreductive surgery in patients with
FIGO stage III ovarian cancer who are eligible for primary cytoreductive
surgery resulting in no residual disease, or residual disease up to 2.5 mm.
Study design
We propose a randomized, controlled, open label, multicenter phase III trial to
evaluate whether the addition of HIPEC procedure increases overall survival in
patients with stage III epithelial ovarian cancer in whom primary cytoreductive
surgery resulting in no residual disease, or residual disease up to 2.5 mm is
reached.
Intervention
Patients in the control arm are treated by primary cytoreductive surgery with
no more than 2.5 mm residual disease, and 6 cycles of adjuvant chemotherapy as
is routinely administered for stage III epithelial ovarian cancer. Patients in
the treatment arm are treated in the same way as the control arm, with the
addition of hyperthermic intra-abdominal perfusion of cisplatin 100 mg/m2 at
the end of the primary cytoreductive surgery (residual disease < 2.5 mm).
Study burden and risks
There is a chance that due to HIPEC during the operation the ovarian cancer is
less likely to come back. The quality of your life may improve in the longer
term.
Participation in this study provides information that could possibly help
cancer patients in the future.
Disadvantages that must be taken into account when participating are:
• Longer operating time in the case of HIPEC
• Longer hospital stay of about 1-2 days in the case of HIPEC
• 1 day stay on medium care / intensive care in case of HIPEC
• possibly a longer hospital stay or extra surgery in case of complications
• additional questionnaires
• extra blood samples and other extra tests such as CT scans, which would
otherwise not be done
• possible side effects and / or adverse effects of HIPEC
*
Plesmanlaan 121
Amsterdam 1066CX
NL
Plesmanlaan 121
Amsterdam 1066CX
NL
Listed location countries
Age
Inclusion criteria
1. signed and written informed consent
2. age >=18
3. histological proven FIGO stage III primary epithelial ovarian, fallopian
tube, or extra-ovarian
cancer, treated with primary complete cytoreduction, or primary
cytoreduction with no more than
2.5 mm residual disease
a. in case of extra-abdominal enlarged lymph nodes, representative
cytology/histology or FDG-
PET scan must be negative;
b. resectable, local bowel involvement, iatrogenic abdominal wall
metastases or umbilical lesions are allowed;
c. in case no histological proof is available before surgery, patients can
be randomized during
surgery based on histological proof on intraoperative frozen section
material
4. fit for major surgery, WHO performance status 0-2
5. adequate bone marrow function, hepatic function and renal function
6. baseline health-outcome questionnaire should be completed before
randomization
7. able to understand the patient information and questionnaires.
Exclusion criteria
1. history of previous malignancy treated with chemotherapy
2. history of previous malignancy within five years prior to inclusion, with
the exception of carcinoma
in situ, radically excised basal cell or squamous cell cancer of the skin
or synchronal
endometrial carcinoma FIGO IA G1/2
3. if complete primary cytoreduction is not feasible
4. in case of a known psychiatric disorder, substance abuse disorder, or high
suspicion of a mental disorder that could interfere with cooperation or
compliance with the requirements of the trial
5. when opting for fertility sparing surgery, or when breastfeeding
6. in case of a known history of Human Immunodeficiency Virus (HIV, or HIV 1/2
antibodies)
7. in case of known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C
(e.g., HCV RNA
[qualitative])
8. patients who received prior treatment for the current malignancy.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2023-509049-11-00 |
| EudraCT | EUCTR2018-003346-17-NL |
| ClinicalTrials.gov | NCT03772028 |
| CCMO | NL63742.031.18 |