LOROCSON study: Late Onset Recurrent Ovarian Cancer: Surgery Or Not
| ISRCTN | ISRCTN50678517 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50678517 |
| Protocol serial number | MEC 2005-128 |
| Sponsor | Erasmus Medical Centre (The Netherlands) |
| Funder | Erasmus Medical Centre (The Netherlands) |
- 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
Scientific
Erasmus Medical Center
Department Obstetrics and Gynecology
Dr. Molewaterplein 60
Rotterdam
3015 GJ
Netherlands
| Phone | +31 (0)10 463 6363 |
|---|---|
| p.vencken@erasmusmc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre, randomised, active controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Study acronym | LOROCSON |
| Study objectives | 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(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Progression-free survival. |
| Key secondary outcome measure(s) |
1. Survival |
| Completion date | 01/10/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 700 |
| Key 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 |
| Key exclusion criteria | 1. More than one line chemotherapy 2. Complete bowel obstruction 3. Metastasised carcinoma (other tumour) 4. Leptomeningeal or brain metastases |
| Date of first enrolment | 01/10/2005 |
| Date of final enrolment | 01/10/2010 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus Medical Center
Rotterdam
3015 GJ
Netherlands
3015 GJ
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
