To investigate whether laparoscopy is cost-effective in predicting which patients will benefit from primary surgery and which patients should be treated with neoadjuvant chemotherapy and interval surgery instead.
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
Our main outcome will be the frequency of futile laparotomies e.g. suboptimal
primary debulking procedures.
Secondary outcome
Secondary outcome measures will be the frequency of complete cytoreductive
surgery (no residual tumor), residual tumor <1 cm, progression free survival,
overall survival, morbidity, quality of life, days in hospital, and costs.
Background summary
Traditionally standard treatment of patients with advanced ovarian cancer is
complete cytoreductive surgery, defined as debulking surgery without residual
tumor, followed by chemotherapy. In cases of suboptimal debulking at primary
surgery patients will be treated with neoadjuvant chemotherapy and interval
debulking to gain an optimal survival. In these patients primary surgery is
futile, causing reduction of quality of life, increasing costs and chances of
more complications, without survival advantage.
In The Netherlands about 40% of primary debulking surgery is suboptimal.
Diagnostic laparoscopy added to the standard clinical and CT evaluation in
selecting patients eligible for primary debulking surgery is likely to be more
reliable in prediction of suboptimal surgery. Randomised research on reduction
in morbidity and costs while adding diagnostic laparoscopy to conventional
staging has not yet been performed.
Hypothesis: Adding laparoscopy to conventional staging in patients suspected of
advanced ovarian carcinoma could prevent unnecessary laparotomy, thus limiting
morbidity and costs.
Study objective
To investigate whether laparoscopy is cost-effective in predicting which
patients will benefit from primary surgery and which patients should be treated
with neoadjuvant chemotherapy and interval surgery instead.
Study design
A multicentre prospective randomized clinical trial. After inclusion and
informed consent 200 patients will be randomized to additional laparoscopy or
direct primary cytoreductive surgery.
Intervention
Additional staging laparoscopy as compared to the standard conventional staging
in the selection for primary cytoreductive surgery or neoadjuvant chemotherapy
plus interval cytoreductive surgery.
Study burden and risks
Women randomised for additional staging laparoscopy will have an extra
operation under general anesthesia and will be admitted for one day in the
hospital. Diagnostic laparoscopy is a routinly performed technique for
gynaecologists, with a low rate of complications. The open technique is thought
to be the safest in our groep of patients. With the laparoscopy a futile
primary debulking can be prevented. All patients have to fill in three
questionaires.
If laparoscopy proves to be cost-effective in improving the frequency of
optimal debulking with equal or better survival rate, this procedure will be
added to conventional staging in all patients. Therefore future patients will
benefit from this trial.
Meibergdreef 9
1105 AZ
NL
Meibergdreef 9
1105 AZ
NL
Listed location countries
Age
Inclusion criteria
All patients suspected of having advanced ovarian cancer between 18-80 years of age, who are scheduled to undergo primary debulking surgery, who signed informed consent
Exclusion criteria
Contraindications for primary cytoreductive surgery, and therefore, exclusion criteria for this study will be:
1. Poor general conditions (WHO performance status >3) and age > 80 years or under 18 years.
2. Intrahepatic metastatic disease > 1 cm.
3. Extra-abdominal metastatic disease (excl. inguinal lymph nodes or pleural fluid).
4. Imaging suggestive of
a. Peri-aortic lymphadenopathy larger than 1 cm above the level of the renal veins. b.Extensive peritoneal carcinomatosis > 1 cm at the diaphragmatic level.
c. Extensive bowel mesentery involvement
5. Large immobile pelvic tumor, probably requiring bowel resection for complete debulking
6. Contra-indication for laparoscopic surgery
Design
Recruitment
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 |
|---|---|
| CCMO | NL31441.018.10 |