Ovarian CancerLOVENCT04710797
Lymphadenectomy in Early Ovarian Cancer
A study testing Completion staging surgery including systematic pelvic and para-aortic lymphadenectomy and Comprehensive staging surgery with no Lymphadenectomy in people with Ovarian Cancer and Lymphadenectomy, run by Sun Yat-sen University at 1 site in China.
Trial summary
To assess the impact of comprehensive staging surgery with no lymphadenectomy on survival and quality of life in patients with early-stage ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Ovarian Cancer, Lymphadenectomy
- What is being tested?
- Completion staging surgery including systematic pelvic and para-aortic lymphadenectomy and Comprehensive staging surgery with no Lymphadenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 656 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2021to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 18 years to 70 years.
- Primary diagnosis of epithelial ovarian cancer FIGO stage IA-IIA ( recevive no prior treatment or receive incomplete initial surgery)，with indications of adjuvant chemotherapy：①High-grade serous carcinoma; ②Grade 3 endometrioid carcinoma; ③Clear cell carcinoma; ④Grade 2 endometrioid carcinoma with capsule ruptured or pelvic tissues extension ⑤Low-grade serous carcinoma、Grade 1 endometrioid carcinoma and Mucinous carcinoma of the ovary with pelvic tissues extension.
- Patients who have given their signed and written informed consent.
- Good performance status (ECOG 0/1).
Who cannot join
- Non epithelial ovarian malignancies and borderline tumors.
- Suspicious lymph nodes at preoperative radiological evaluation.
- Intraoperative clinically suspicious lymph nodes (bulky nodes).
- 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.
- Prior chemotherapy for ovarian cancer or abdominal/pelvic radiotherapy.
- Diseases of the lymph system (including lymph edema of unknown origin).
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- Prior retroperitoneal lymph node dissection (systematic or sampling).
- Any other concurrent medical conditions contraindicating surgery.
- Pregnancy.
- Any reasons interfering with giving of informed consent , abiding by protocol, or regular follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Jihong Liu, Ph.D., 86-20-87343102, liujih@mail.sysu.edu.cn
Ting Deng, Ph.D., 86-20-87343105, dengting@sysucc.org.cn
About this study
Official title: A Prospective Randomized Multicentre Trial for Lymphadenectomy in Early-stage Ovarian Cancer
To assess the impact of comprehensive staging surgery with no lymphadenectomy on survival and quality of life in patients with early-stage ovarian cancer.
Read the detailed description
OBJECTIVES: Compare the efficacy and safety in patients with International Federation of Gynecology and Obstetrics (FIGO) stage IA -IIA epithelial ovarian cancer, undergo completion staging surgery including systematic pelvic and para-aortic lymphadenectomy versus comprehensive staging surgery without lymphadenectomy.
OUTLINE: This is a randomized phase III multicenter study. Patients will receive comprehensive staging surgery without Lymphadenectomy or completion staging surgery including systematic pelvic and para-aortic lymphadenectomy, and the adjuvant chemotherapy will accord to National Comprehensive Cancer Network (NCCN) guidelines. Patients are followed up every 3 months within the first 2 years, and then every 6 months.
PROJECTED ACCRUAL: A total of 656 patients will be recruited for this study within 5 years.
- Conditions
- Ovarian Cancer, Lymphadenectomy
- Being tested
- Completion staging surgery including systematic pelvic and para-aortic lymphadenectomy, Comprehensive staging surgery with no Lymphadenectomy
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Completion staging surgery including systematic pelvic and para-aortic lymphadenectomyProcedure or surgery
- open or minimally invasive surgical approach
- cytologic examinations
- All peritoneal surfaces should be visualized, and any peritoneal suspicious for metastasis should be selectively excised or biopsied
- BSO and hysterectomy
- For selected patients desiring to preserve fertility, USO or BSO with uterine preservation may be considered
- Omentectomy
- Para-aortic lymph node dissection should be performed by stripping the nodal tissue from the vena cava and the aorta bilaterally to at least the level of the inferior mesenteric artery and preferably to the level of the renal vessels
- The preferred method of dissecting pelvic lymph nodes is bilateral removal of lymph nodes overlying and anterolateral to the common iliac vessel, overlying and medial to the external iliac vessel, overlying and medial to the hypogastric vessels, and from the obturator fossa at a minimum anterior to the obturator nerve
Comprehensive staging surgery with no LymphadenectomyProcedure or surgery
- open or minimally invasive surgical approach
- cytologic examinations
- All peritoneal surfaces should be visualized, and any peritoneal suspicious for metastasis should be selectively excised or biopsied
- BSO and hysterectomy
- For selected patients desiring to preserve fertility, USO or BSO with uterine preservation may be considered
- Omentectomy
- In open approach surgery, exploring the pelvic and Para-aortic lymph node with hand. In minimally invasive surgery, the peritoneal above the pelvic and Para-aortic lymph node area should be open and visualized.Biopsy and frozen section of the suspicious lymph nodes
| Study group | Role | What they receive |
|---|---|---|
| No Lymphadenectomy | Experimental | Comprehensive staging surgery with no Lymphadenectomy Receives: Procedure: Comprehensive staging surgery with no Lymphadenectomy |
| Lymphadenectomy | Active comparator | Completion staging surgery including systematic pelvic and para-aortic lymphadenectomy Receives: Procedure: Completion staging surgery including systematic pelvic and para-aortic lymphadenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS(Progression-free survival)
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Secondary outcomes (4)
OS(Overall Survival)
From date of randomization until the date of death from any cause or date of last follow up, whichever came first
Measured: From date of randomization until the date of death from any cause or date of last follow up, up to 100 mons
Recurrence rate of lymph node
The recurrence rate in the retroperitoneal lymph nodes after primary surgery
Measured: 3 years
QoL(Quality of life)
Quality of life before surgery, and at 6 months and 1 year after surgery in both groups will be evaluated using European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire
Measured: Baseline, 6 months and 1 year after surgery
Postoperative complications
The difference of the rate of Postoperative complications between two groups
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start31 Jan 2021 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- comprehensive staging surgery with or without lymphadenectomy
- Masking
- None (open label)
- Enrolment
- 656 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jihong Liu, Sun Yat-sen University
- Investigators
- Jihong Liu, Ph.D., Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04710797
- Sponsor's protocol ID
- 2020-FXY-405
- Acronym
- LOVE
- Status last verified
- Jan 2021
- First submitted
- 11 Jan 2021
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Deng T, Liu K, Chen L, Chen X, Li HW, Guo H, Zhang H, Xiang L, Feng X, Wang X, Ngan HY, Zhao J, Zou D, Liu Q, Liu J. A prospective randomized multicenter trial for lymphadenectomy in early-stage ovarian cancer: LOVE study. J Gynecol Oncol. 2023 May;34(3):e52. doi: 10.3802/jgo.2023.34.e52. Epub 2023 Apr 10.
PubMed 37116952
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Multicentre Trial for Lymphadenectomy in Early-stage Ovarian Cancer
- ClinicalTrials.gov ID
- NCT04710797
- Acronym / sponsor ID
- LOVE / 2020-FXY-405
- Conditions
- Ovarian Cancer, Lymphadenectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 656 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 31 Jan 2021 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 15 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the impact of comprehensive staging surgery with no lymphadenectomy on survival and quality of life in patients with early-stage ovarian cancer.
Detailed description
OBJECTIVES: Compare the efficacy and safety in patients with International Federation of Gynecology and Obstetrics (FIGO) stage IA -IIA epithelial ovarian cancer, undergo completion staging surgery including systematic pelvic and para-aortic lymphadenectomy versus comprehensive staging surgery without lymphadenectomy.
OUTLINE: This is a randomized phase III multicenter study. Patients will receive comprehensive staging surgery without Lymphadenectomy or completion staging surgery including systematic pelvic and para-aortic lymphadenectomy, and the adjuvant chemotherapy will accord to National Comprehensive Cancer Network (NCCN) guidelines. Patients are followed up every 3 months within the first 2 years, and then every 6 months.
PROJECTED ACCRUAL: A total of 656 patients will be recruited for this study within 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- comprehensive staging surgery with or without lymphadenectomy
| Arm | Type | Receives |
|---|---|---|
| No Lymphadenectomy | Experimental | Procedure: Comprehensive staging surgery with no LymphadenectomyComprehensive staging surgery with no Lymphadenectomy |
| Lymphadenectomy | Active comparator | Procedure: Completion staging surgery including systematic pelvic and para-aortic lymphadenectomyCompletion staging surgery including systematic pelvic and para-aortic lymphadenectomy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women aged 18 years to 70 years.
- Primary diagnosis of epithelial ovarian cancer FIGO stage IA-IIA ( recevive no prior treatment or receive incomplete initial surgery)，with indications of adjuvant chemotherapy：①High-grade serous carcinoma; ②Grade 3 endometrioid carcinoma; ③Clear cell carcinoma; ④Grade 2 endometrioid carcinoma with capsule ruptured or pelvic tissues extension ⑤Low-grade serous carcinoma、Grade 1 endometrioid carcinoma and Mucinous carcinoma of the ovary with pelvic tissues extension.
- Patients who have given their signed and written informed consent.
- Good performance status (ECOG 0/1).
Key exclusion criteria (10 listed)
- Non epithelial ovarian malignancies and borderline tumors.
- Suspicious lymph nodes at preoperative radiological evaluation.
- Intraoperative clinically suspicious lymph nodes (bulky nodes).
- 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.
- Prior chemotherapy for ovarian cancer or abdominal/pelvic radiotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Completion staging surgery including systematic pelvic and para-aortic lymphadenectomy* open or minimally invasive surgical approach * cytologic examinations * All peritoneal surfaces should be visualized, and any peritoneal suspicious for metastasis should be selectively excised or biopsied * BSO and hysterectomy * For selected patients desiring to preserve fertility, USO or BSO with uterine preservation may be considered * Omentectomy * Para-aortic lymph node dissection should be performed by stripping the nodal tissue from the vena cava and the aorta bilaterally to at least the level of the inferior mesenteric artery and preferably to the level of the renal vessels * The preferred method of dissecting pelvic lymph nodes is bilateral removal of lymph nodes overlying and anterolateral to the common iliac vessel, overlying and medial to the external iliac vessel, overlying and medial to the hypogastric vessels, and from the obturator fossa at a minimum anterior to the obturator nerve | Procedure or surgery | Lymphadenectomy |
| Comprehensive staging surgery with no Lymphadenectomy* open or minimally invasive surgical approach * cytologic examinations * All peritoneal surfaces should be visualized, and any peritoneal suspicious for metastasis should be selectively excised or biopsied * BSO and hysterectomy * For selected patients desiring to preserve fertility, USO or BSO with uterine preservation may be considered * Omentectomy * In open approach surgery, exploring the pelvic and Para-aortic lymph node with hand. In minimally invasive surgery, the peritoneal above the pelvic and Para-aortic lymph node area should be open and visualized.Biopsy and frozen section of the suspicious lymph nodes | Procedure or surgery | No Lymphadenectomy |
Primary outcome
PFS(Progression-free survival)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first
4 secondary outcomes
OS(Overall Survival)
Time frame: From date of randomization until the date of death from any cause or date of last follow up, up to 100 mons
Recurrence rate of lymph node
Time frame: 3 years
QoL(Quality of life)
Time frame: Baseline, 6 months and 1 year after surgery
Postoperative complications
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Derived from this study: PubMed 37116952Deng T, Liu K, Chen L, Chen X, Li HW, Guo H, Zhang H, Xiang L, Feng X, Wang X, Ngan HY, Zhao J, Zou D, Liu Q, Liu J. A prospective randomized multicenter trial for lymphadenectomy in early-stage ovarian cancer: LOVE study. J Gynecol Oncol. 2023 May;34(3):e52. doi: 10.3802/jgo.2023.34.e52. Epub 2023 Apr 10.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jihong Liu, Ph.D. principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Completion staging surgery including systematic pelvic and para-aortic lymphadenectomy and Comprehensive staging surgery with no Lymphadenectomy in people with Ovarian Cancer and Lymphadenectomy, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jihong Liu, Ph.D. (86-20-87343102, liujih@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS(Progression-free survival) (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04710797, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2021.