Contact information
Type
Scientific
Primary contact
Dr P.M.L.H. Vencken
ORCID ID
Contact details
Erasmus Medical Center
Department Obstetrics and Gynecology
Dr. Molewaterplein 60
Rotterdam
3015 GJ
Netherlands
+31 (0)10 463 6363
p.vencken@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MEC 2005-128
Study information
Scientific title
A randomised phase III study for the treatment of recurrent epithelial ovarian cancer: chemotherapy alone versus chemotherapy followed by secondary cytoreductive surgery in patients with a disease-free interval of more than 6 months
Acronym
LOROCSON
Study hypothesis
The median progression-free survival in the chemotherapy-alone arm is assumed to be 13 months. It is assumed that the addition of surgery increases the median progression-free survival with four months.
Ethics approval
Received from the local medical ethics committee
Study design
Multicentre, randomised, active controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Ovarian cancer
Intervention
After registration the patient will immediately start the first course of chemotherapy. After the induction chemotherapy the response to therapy will be evaluated. In case of progressive disease the patient will go off treatment. The other patients will be randomised to either continuation of the chemotherapy without surgery (treatment A) versus secondary cytoreductive surgery followed by chemotherapy (treatment B).
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Progression-free survival.
Secondary outcome measures
1. Survival
2. Toxicity
3. Surgical treatment related complications
4. Quality of life
Overall trial start date
01/10/2005
Overall trial end date
01/10/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Recurrence of epithelial ovarian cancer
2. After first line chemotherapy with a disease-free interval of at least 6 months
3. Aged greater than 18 years
4. World Health Organization (WHO) Performance Status 0 - 2
5. First-line therapy should have consisted of at least four courses of either cisplatin or carboplatin
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
700
Participant exclusion criteria
1. More than one line chemotherapy
2. Complete bowel obstruction
3. Metastasised carcinoma (other tumour)
4. Leptomeningeal or brain metastases
Recruitment start date
01/10/2005
Recruitment end date
01/10/2010
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus Medical Center
Rotterdam
3015 GJ
Netherlands
Sponsor information
Organisation
Erasmus Medical Centre (The Netherlands)
Sponsor details
Department of Obstetrics and Gynecology
Dr. Molewaterplein 60
Rotterdam
3015 GJ
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Erasmus Medical Centre (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary