Condition category
Cancer
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
13/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.erasmusmc.nl/content/englishindex.htm

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

Publication citations

Additional files

Editorial Notes