- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04710797
Lymphadenectomy in Early Ovarian Cancer (LOVE)
A Prospective Randomized Multicentre Trial for Lymphadenectomy in Early-stage Ovarian Cancer
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jihong Liu, Ph.D.
- Phone Number: 86-20-87343102
- Email: Liujih@mail.sysu.edu.cn
Study Contact Backup
- Name: Ting Deng, Ph.D.
- Phone Number: 86-20-87343105
- Email: dengting@sysucc.org.cn
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510060
- Recruiting
- Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center
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Contact:
- Jihong Liu, Ph.D.
- Phone Number: 86-20-87343102
- Email: Liujih@mail.sysu.edu.cn
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Contact:
- Ting Deng, Ph.D.
- Phone Number: 86-20-87343105
- Email: dengting@sysucc.org.cn
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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).
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: No Lymphadenectomy
Comprehensive staging surgery with no Lymphadenectomy
|
|
Active Comparator: Lymphadenectomy
Completion staging surgery including systematic pelvic and para-aortic lymphadenectomy
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
From date of randomization until the date of death from any cause or date of last follow up, whichever came first
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From date of randomization until the date of death from any cause or date of last follow up, up to 100 mons
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Recurrence rate of lymph node
Time Frame: 3 years
|
The recurrence rate in the retroperitoneal lymph nodes after primary surgery
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3 years
|
QoL(Quality of life)
Time Frame: Baseline, 6 months and 1 year after surgery
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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
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Baseline, 6 months and 1 year after surgery
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Postoperative complications
Time Frame: 3 years
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The difference of the rate of Postoperative complications between two groups
|
3 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jihong Liu, Ph.D., Sun Yat-sen University
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
Other Study ID Numbers
- 2020-FXY-405
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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