Survival Effect of Hepato-celiac Lymphadenectomy In Primary or Relapsed Ovarian Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorShanghai Gynecologic Oncology Group
About this trial
The purpose of this study is to evaluate the safety and the effectiveness of hepato-celiac lymphadenectomy in the treatment of primarily diagnosed advanced epithelial ovarian cancer and platinum-sensitive recurrent ovarian cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years to ≤ 75 years.
Pathologic confirmed stage III or IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma (EOC, PPC, FTC) or platinum sensitive, relapsed EOC, PPC or FTC (no more than 4 lines of therapy)
Hepato-celiac lymph nodes metastases diagnosed by imaging before surgery and enlarged palpable lymph nodes by surgical findings
Assessed by the experienced surgeons, complete resection is feasible according to preoperative evaluation
Disqualifiers
Patients with non-epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma.
Low-grade carcinoma.
Mucinous ovarian cancer.
Infeasible complete resection according to preoperative evaluation
Trial design
Design model
Single group
Treatments tested in this trial
Hepato-celiac lymphadenectomy
Procedure/SurgeryHepato-celiac lymphadenectomy in the treatment of epithelial ovarian cancer, with a maximum cytoreduction, in the circumstance of primarily diagnosed advanced epithelial ovarian cancer (primary debulking surgery or interval debulking surgery) and of platinum-sensitive recurrent ovarian cancer (no more than 4 lines of therapy).
Treatment groups
94 Participants
are divided into 1 treatment groupGroup A: Hepato-celiac lymphadenectomyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
2-years Non-Progression Rate
The proportion of patients without disease progression or death at 2 years after entry into the study.
Time frame
Participants will be followed up to 2 years after randomizationSecondary outcomes
1
Progression free survival
The time from entry into the study to the diagnosis of the first progression or recurrence or death, whichever occurs first
Time frame
Participants will be followed up to 24 months after randomization2
Overall survival
The time from date of randomization until the date of death from any cause or last follow-up
Time frame
Participants will be followed up to 60 months after randomization3
Objective response rate
The proportion of patients who achieved complete response (CR) or partial response (PR)
Time frame
Participants will be followed up to 24 months after randomization4
Disease control rate
The proportion of patients who achieved complete response (CR) or partial response (PR) or stable disease (SD)
Time frame
Participants will be followed up to 24 months after randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Shanghai Gynecologic Oncology Group
Lead sponsor
Fudan University
Collaborator
Source ClinicalTrials.gov