A Randomized Prospective Trail of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Recurrent Ovarian Cancer Patients With Mutations in Homologous Recombination Repair (HRR) Genes
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Ovarian Cancer
- Sponsor
- CAI Hongbing
- Enrollment
- 280
- Locations
- 1
- Primary Endpoint
- Progression-free Survival
- Last Updated
- 5 years ago
Overview
Brief Summary
A phase III prospective study with the primary objective to investigate the benefit of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in ovarian cancer patients with mutations in homologous recombination repair (HRR) genes. The target population for this study is patients with recurrent ovarian, peritoneal or fallopian tube cancers undergoing Cytoreductive Surgery (CRS). Patients will be divided into two groups according to HRR genes mutation, each group will be further divided into two sub-groups with different intervention. Patients in Group A are HRR mutated type, sub-group 1 will undergo CRS plus HIPEC and then go on to receive standard platinum-based combination doublet intravenous chemotherapy, sub-group 2 will undergo CRS and then go on to intravenous chemotherapy. Patients in Group B are HRR wild type, sub-group 3 will undergo CRS plus HIPEC and then go on to receive standard platinum-based combination doublet intravenous chemotherapy, sub-group 4 will undergo CRS and then go on to intravenous chemotherapy. All patients will receive maintenance therapy with Niraparib after primary treatment. Prognostic information will be collected for investigation of survival benefits of patients.
Investigators
CAI Hongbing
Dr. Prof.
Zhongnan Hospital
Eligibility Criteria
Inclusion Criteria
- •age 18-75
- •Karnofsky performance status \>50 or World Health Organization performance score \< 2
- •primary or recurrence ovarian, peritoneal or fallopian tube epithelial cancer; first intra-abdominal recurrence without distant metastasis (including: unique resectable pleural metastasis which are platinum-sensitive; resectable single lymphatic metastasis retroperitoneal or inguinal)
- •preoperative platinum-based chemotherapy (carboplatin and paclitaxel, carboplatin and liposomal doxorubicin, gemcitabine, trabectedin or topotecan)
- •lesion can be removed completely or residual disease \< 0.5 cm
- •last chemotherapy finished no more than 12 weeks after surgery
- •no hepatic function damage
- •white blood cell count ≥3.5\*10\^9/L; platelet count ≥80\*10\^9/L; Hemoglobin ≥90g/L
- •no contraindication of surgery and anesthesia
- •life expectancy ≥ 3 months
Exclusion Criteria
- •age \< 18 or \>75
- •no history of other cancer
- •platinum allergy
- •distant metastasis
- •used anti-angiogenic drug within 8 weeks
- •possibility of more than two resection of alimentary canal
- •recurrence \< 6 months after primary treatment
- •histologic type: non epithelial origin
- •infection out of control
- •follow-up unable to carry on (geographic or psychic)
Outcomes
Primary Outcomes
Progression-free Survival
Time Frame: up to 36 months since diagnosis
The progression-free survival interval was the time between diagnosis and evidence of recurrent or progressive disease.
Secondary Outcomes
- Overall Survival(up to 36 months since histological diagnosis)
- DP12(the 1 day of histological diagnosis and 12 months after)
- DP9(the 1 day of histological diagnosis and 9 months after)
- Serious adverse events, SAEs(surgery and with in 30 days)