Clinical trial NCT05236686: Survival Effect of Hepato-celiac Lymphadenectomy In Primary or Relapsed Ovarian Cancer
Official title: A Prospective, Single-center, Single-Arm Phase II Clinical Study to Evaluate Safety and Effectiveness of Hepato-celiac Lymphadenectomy in the Treatment of Advanced and Recurrent Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Epithelial Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Carcinoma
Keywords: Ovarian Cancer
Surgery
Lymph Node Metastasis
Hepato-celiac Lymphadenectomy
Lead sponsor: Shanghai Gynecologic Oncology Group
Sponsor class: OTHER_GOV
Collaborators: name: Fudan University
First posted: 2022-02-11
Enrollment: 69
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This single-arm, single-center, phase II trial is to evaluate the safety and effectiveness of hepato-celiac lymphadenectomy in the treatment of ovarian cancer with hepato-celiac lymph nodes metastases, 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).

Eligibility criteria: Inclusion Criteria:

* 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)
* Assessed by the experienced surgeons, complete resection is feasible according to preoperative evaluation
* 1 to 3 episodes of neoadjuvant chemotherapy is allowed in primary settings
* Platinum sensitive relapse is defined as those with platinum-free interval of 6 months or more.
* ASA score of 1 to 2
* ECOG performance status of 0 to 2
* Adequate bone marrow, liver and renal function to receive chemotherapy and subsequently to undergo surgery:
* White blood cells \>3,000/µL, absolute neutrophil count ≥1,500/µL, platelets ≥100,000/µL, hemoglobin ≥9 g/dL,
* Serum creatinine \<1.25 x upper normal limit (UNL) or creatinine clearance ≥60 mL/min according to Cockcroft-Gault formula or to local lab measurement
* Serum bilirubin \<1.25 x UNL, AST(SGOT) and ALT(SGPT) \<2.5 x UNL
* Comply with the study protocol and follow-up.
* Written informed consent.

Exclusion Criteria:

* 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
* Unresectable pulmonary and hepatic parenchymal metastases, multiple thoracic lymph nodes metastases, brain or bone metastases according to preoperative evaluation.
* Carcinomatosis on small bowel mesentery or intestinal wall by surgical findings and infeasible optimal surgery by bowel resection or peritonectomy.
* Progression after neoadjuvant chemotherapy in primary settings.
* Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ or breast cancer (without any signs of relapse or activity).
* Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise the adherence to the protocol.
* Other conditions, such as religious, psychological and other factors, that could interfere with provision of informed consent, compliance to study procedures, or follow-up.

Primary outcomes:
measure: 2-years Non-Progression Rate
timeFrame: Participants will be followed up to 2 years after randomization
Secondary outcomes:
measure: Progression free survival
timeFrame: Participants will be followed up to 24 months after randomization
measure: Overall survival
timeFrame: Participants will be followed up to 60 months after randomization
measure: Objective response rate
timeFrame: Participants will be followed up to 24 months after randomization
measure: Disease control rate
timeFrame: Participants will be followed up to 24 months after randomization
measure: Post-operative complications
timeFrame: Participants will be followed up to 90 days after randomization
measure: Quality of life assessments (QLQ-C30)
timeFrame: Baseline; 6 months, 12 months and 24 months after randomization
measure: Quality of life assessments (FACT-Q)
timeFrame: Baseline; 6 months, 12 months and 24 months after randomization
measure: Patterns of subsequent recurrence
timeFrame: Participants will be followed up to 24 months after randomization
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
Study officials:
affiliation: Fudan University
name: Rongyu Zang
role: STUDY_CHAIR
References: