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 involves toxicity and morbidity, quality of life,…
ID
Source
Brief title
Condition
- Reproductive neoplasms male malignant and unspecified
- Ovarian and fallopian tube disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Recurrence free survival
Secondary outcome
toxicity;morbidity, quality of life; overall survival; tumour response
Background summary
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 100.000. 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 consist 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 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).
Study objective
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 involves 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
Intervention
Intervaldebulking with or without rinsing of the abdomen during surgery with
cisplatin under hyperthermic conditions.
Study burden and risks
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).
During surgery tissue samples will be taken from the abdominal cavity for
pathohistological studies.
From patients who participate in the farmacokinetic study (20) an additonal 2
biopsies will be taken from the abdominal cavity during surgery. In additon 6
bloodsamples will be taken during 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 physical exam,
routine pelvic exam and a vaginal ultrasound is performed.
CT-scans will be performed in the first 2 years before randomisation (twice)
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. In additon there might be a
higher chance on bowel perforation among the patients treated with OVHIPEC
which can result in a longer hospital stay and possibly an operation. To
prevent systemic side effects of intra-abdominally administered cisplatin,
sodium thiosulphate is administered intravenously during surgery.
Plesmanlaan 121
1066 CX Amsterdam
NL
Plesmanlaan 121
1066 CX Amsterdam
NL
Listed location countries
Age
Inclusion criteria
1. age between 18 and 76 years
2. histological or cytological proven primary epithelial ovarian carcinoma or peritoneal cancer (PPSC) or fallopian tube carcinoma FIGO stage III, including serous papillary adenocarcinoma, mucinous adenocarcinoma and endometrioid adenocarcinoma.
3. in case of pleural effusion cytology should be negative for tumour cells
4. In case diagnosis is made based on cytology only (i.e. patients treated by primary chemotherapy) additional criteria apply:
§ Normal mammogram (< 6 weeks before first registration) and
§ Presence of pelvic mass and
§ CA 125 > 200 kU/l and
§ Serum CA125/CEA ratio > 25. If the serum CA125/CEA ratio is < 25, a barium enema or colonoscopy and gastroscopy or radiological examination of the stomach should be negative for the presence of a primary tumour of the digeste tract (< 6 weeks before first registration) and
§ Omental cake or other metastases larger than 2 cm in the upper abdomen and/or regional lymphnode metastasis irrespective of size (CT/MRI or ultrasound or laparoscopy)
5. Patients eligible for interval debulking for the following 2 reasons:
- Primary debulking surgery not feasible due to tumour extension or general
condition (patients treated by primary chemotherapy) or
- Incomplete primary debulking with residual disease > 1 cm
6. In case of primary chemotherapy:
- chemotherapy consists of 3 courses of carboplatin or cisplatin combined
with taxol
- Following 2 cycles of chemotherapy no progression should occur
7. In case of an incomplete primary debulking as indicated under 5 followed by chemotherapy:
- chemotherapy consists of 3 courses of carboplatin or cisplatin combined
with taxol
8. General criteria:
- Fit for major surgery, ASA 1 or ASA 2
- WHO performance status 0-2
- Written informed consent
- Laboratory values: serum creatinine < 140 µmol/L; creatinine clearance > 60 ml/min (Cockroft formula) ; white blood cell count > 3.5 x 109/l; platelets > 100 x 109 /l
9. For quality of life studies:
- baseline questionnaires should be filled in before randomisation
Exclusion criteria
History of breast cancer or previous malignancies within 5 years prior to inclusion, with the exception of radically excised basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
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 |
|---|---|
| EudraCT | EUCTR2006-003466-34-NL |
| CCMO | NL14635.031.06 |