LOROCSON study: Late Onset Recurrent Ovarian Cancer: Surgery Or Not

ISRCTN ISRCTN50678517
DOI https://doi.org/10.1186/ISRCTN50678517
Secondary identifying numbers MEC 2005-128
Submission date
20/12/2005
Registration date
20/12/2005
Last edited
13/10/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr P.M.L.H. Vencken
Scientific

Erasmus Medical Center
Department Obstetrics and Gynecology
Dr. Molewaterplein 60
Rotterdam
3015 GJ
Netherlands

+31 (0)10 463 6363
p.vencken@erasmusmc.nl

Study information

Study designMulticentre, randomised, active controlled, parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleA 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
Study acronymLOROCSON
Study objectivesThe 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(s)Received from the local medical ethics committee
Health condition(s) or problem(s) studiedOvarian cancer
InterventionAfter 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 typeOther
Primary outcome measureProgression-free survival.
Secondary outcome measures1. Survival
2. Toxicity
3. Surgical treatment related complications
4. Quality of life
Overall study start date01/10/2005
Completion date01/10/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants700
Key inclusion criteria1. 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
Key exclusion criteria1. More than one line chemotherapy
2. Complete bowel obstruction
3. Metastasised carcinoma (other tumour)
4. Leptomeningeal or brain metastases
Date of first enrolment01/10/2005
Date of final enrolment01/10/2010

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Erasmus Medical Center
Rotterdam
3015 GJ
Netherlands

Sponsor information

Erasmus Medical Centre (The Netherlands)
Hospital/treatment centre

Department of Obstetrics and Gynecology
Dr. Molewaterplein 60
Rotterdam
3015 GJ
Netherlands

http://www.erasmusmc.nl/content/englishindex.htm
ROR logo https://ror.org/018906e22

Funders

Funder type

Hospital/treatment centre

Erasmus Medical Centre (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan
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