Lymphadenectomy in ovarian neoplasms
| ISRCTN | ISRCTN05335540 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN05335540 |
| ClinicalTrials.gov number | NCT00712218 |
| Secondary identifying numbers | AGO-Ovar OP.3 |
- Submission date
- 09/10/2008
- Registration date
- 23/10/2008
- Last edited
- 10/04/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Ovarian cancers are classed as advanced when the cancer has spread away from the ovary to other parts of the body, such as the lymph nodes. Lymphadenectomy is a surgical procedure that it is often carried out as part of cancer treatment to remove groups of lymph nodes (e.g., the pelvic and para-aortic lymph nodes). The aim of this study is to assess the effectiveness of pelvic and para-aortic lymphadenectomy in patients with advanced ovarian cancer, in terms of its safety and its effects on patient survival and quality of life.
Who can participate?
Women aged 18-75 with advanced ovarian cancer
What does the study involve?
Participants are randomly allocated to one of two groups. One group undergoes standard surgery for advanced ovarian cancer, while the other group undergoes standard surgery and lymphadenectomy. Patient survival, quality of life and complications are assessed in the two groups.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Philipps-University of Marburg (Germany)
When is the study starting and how long is it expected to run for?
October 2008 to December 2017
Who is funding the study?
German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany)
Who is the main contact?
Prof Uwe Wagner
Contact information
Scientific
Klinik für Gynäkologie
Baldingerstrasse
Marburg
35032
Germany
Study information
| Study design | Open randomised prospective multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Lymphadenectomy in ovarian neoplasms |
| Study acronym | LION |
| Study objectives | The primary study objective is to assess the efficacy of systematic pelvic and para-aortic lymphadenectomy in patients with advanced ovarian cancer and intra-abdominal complete debulking with respect to overall survival. Secondary objectives are the safety of systematic pelvic and para-aortic lymphadenectomy in these patients and the effect of systematic lymphadenectomy on progression-free survival (PFS) and quality of life (QoL). A further objective is to explore the association of number of resected lymph nodes and primary and secondary outcome measures. |
| Ethics approval(s) | Ethics committee of the Philipps-University of Marburg, 11/08/2008, ref: AZ 115/08 |
| Health condition(s) or problem(s) studied | Ovarian cancer |
| Intervention | Control group: standard surgery Intervention group: standard surgery + lymphadectomy |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Overall survival. Time frame: time from randomisation until death. |
| Secondary outcome measures | 1. Progression-free survival (PFS). Time frame: Progression-free survival time is calculated from the date of surgery until the date of first progressive disease or death, whichever occurs first or date of last contact. 2. Quality of life (QoL) as measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer patients (EORTC QLQ-C30), OV28 at baseline, Day 7-21 after surgery, at Visit 2 (within 6 weeks after end of primary chemotherapy or 6 months after surgery, whichever occurs first), 6 months after chemotherapy 3. Number of resected lymph nodes. Time frame: intra operative 4. Complications. Time frame: intra operative, 60 days after surgery |
| Overall study start date | 23/10/2008 |
| Completion date | 31/12/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Female |
| Target number of participants | 640 |
| Key inclusion criteria | 1. Primary diagnosis of invasive epithelial ovarian cancer, Federation of Obstetricians and Gynaecologists (FIGO) stage IIB-IV (IV only if resectable metastasis in pleura, liver, spleen, and/or abdominal wall) 2. Macroscopic complete resection 3. Age 18-75 years 4. Patients who have given their signed and written informed consent 5. Good performance status (Eastern Cooperative Oncology Group [ECOG] 0/1) |
| Key exclusion criteria | 1. Non epithelial ovarian malignancies and borderline tumours 2. Intraoperative clinically suspicious lymph nodes (bulky nodes) 3. Secondary invasive neoplasms in the last 5 years (except synchronal endometrial carcinoma FIGO IA G1/2, non melanoma skin cancer, breast cancer T1 N0 M0 G1/2) or with any signs of relapse or activity 4. Recurrent ovarian cancer 5. Prior chemotherapy for ovarian cancer or abdominal/pelvic radiotherapy 6. Diseases of the lymph system (including lymph oedema of unknown origin) 7. Clinically relevant dysfunctions of blood clotting (including medicamentous conditioned reasons, e.g., ASS, if not stopped at least 7 days prior to surgery) 8. Any significant medical reasons, age or performance status that contraindicate the study procedures (in the opinion of investigator) 9. Prior retroperitoneal lymph node dissection (systematic or sampling) 10. Pregnancy 11. Those who suffer from dementia or significantly altered mental status, and therefore, are unable to understand the trial details and give informed consent 12. Any reasons interfering with regular follow-up |
| Date of first enrolment | 23/10/2008 |
| Date of final enrolment | 31/12/2017 |
Locations
Countries of recruitment
- Germany
Study participating centre
35032
Germany
Sponsor information
University/education
Robert-Kochstr. 5
Marburg
35037
Germany
| Website | http://www.kks-mr.de |
|---|---|
"ROR" |
https://ror.org/01rdrb571 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- German Research Association, German Research Foundation, DFG
- Location
- Germany
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 28/02/2019 | 10/04/2019 | Yes | No |
Editorial Notes
10/04/2019: Publication reference added.
24/03/2016: Plain English summary added.
