Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
Conditions
Keywords
Ovarian Cancer, Surgery, Lymph Node Metastasis, Hepato-celiac Lymphadenectomy
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, multi-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).
Interventions
PROCEDUREHepato-celiac lymphadenectomy
Hepato-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).
Sponsors
Fudan University
Shanghai Gynecologic Oncology Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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) * 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 * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2-years Non-Progression Rate | Participants will be followed up to 2 years after randomization | The proportion of patients without disease progression or death at 2 years after entry into the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | Participants will be followed up to 60 months after randomization | The time from date of randomization until the date of death from any cause or last follow-up |
| Objective response rate | Participants will be followed up to 24 months after randomization | The proportion of patients who achieved complete response (CR) or partial response (PR) |
| Disease control rate | Participants will be followed up to 24 months after randomization | The proportion of patients who achieved complete response (CR) or partial response (PR) or stable disease (SD) |
| Progression free survival | Participants will be followed up to 24 months after randomization | The time from entry into the study to the diagnosis of the first progression or recurrence or death, whichever occurs first |
| Quality of life assessments (QLQ-C30) | Baseline; 6 months, 12 months and 24 months after randomization | Assessment of potential impact of first line treatment on functionality and well-being in patients by the EORTC core quality of life questionnaire (QLQ-C30, version 3.0). |
| Quality of life assessments (FACT-Q) | Baseline; 6 months, 12 months and 24 months after randomization | Assessment of potential impact of first line treatment on functionality and well-being in patients by functional assessment of cancer therapy-ovary (FACT-O, version 4). |
| Patterns of subsequent recurrence | Participants will be followed up to 24 months after randomization | The number and sites of subsequent recurrence, including pelvic, abdominal, retroperitoneal lymph nodes, hepato-celiac lymph nodes and distant metastases and ascites, etc. |
| Post-operative complications | Participants will be followed up to 90 days after randomization | Postoperative 30-day, 60-day and 90-day complications |
Countries
China
Contacts
Primary ContactLibing Xiang
Backup ContactRong Jiang
Outcome results
None listed