Condition category
Cancer
Date applied
09/10/2008
Date assigned
23/10/2008
Last edited
24/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Uwe Wagner

ORCID ID

Contact details

Klinik für Gynäkologie
Baldingerstrasse
Marburg
35032
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00712218

Protocol/serial number

AGO-Ovar OP.3

Study information

Scientific title

Lymphadenectomy in ovarian neoplasms

Acronym

LION

Study hypothesis

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

Ethics committee of the Philipps-University of Marburg, 11/08/2008, ref: AZ 115/08

Study design

Open randomised prospective multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Ovarian cancer

Intervention

Control group: standard surgery
Intervention group: standard surgery + lymphadectomy

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

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 trial start date

23/10/2008

Overall trial end date

31/12/2017

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

640

Participant 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

Recruitment start date

23/10/2008

Recruitment end date

31/12/2017

Locations

Countries of recruitment

Germany

Trial participating centre

Klinik für Gynäkologie
Marburg
35032
Germany

Sponsor information

Organisation

Philipps-University of Marburg (Germany)

Sponsor details

Robert-Kochstr. 5
Marburg
35037
Germany

Sponsor type

University/education

Website

http://www.kks-mr.de

Funders

Funder type

Government

Funder name

Deutsche Forschungsgemeinschaft (ref: GZ: WA 740/4-1)

Alternative name(s)

German Research Foundation, DFG

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Germany

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

24/03/2016: Plain English summary added.