Ovarian Cancer, Epithelial Ovarian Cancer, Ovarian Cancer, Epithelial, Hyperthermic Intraperitoneal Chemotherapy(HIPEC), Homologous Recombination Repair Gene Mutation
Conditions
Keywords
Homologous Recombination Repair Gene Mutation, hyperthermic intraperitoneal chemotherapy, Epithelial Ovarian Cancer
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.
Interventions
PROCEDURECRS+HIPEC
Patients will undergo only CRS, HIPEC and IVCT.Patients will receive standard platinum-based combination doublet chemotherapy for 6-8 cycles after CRS and then followed by maintenance therapy. A single drug lobaplatin(30mg/m2)will be administered in normal saline via HIPEC and it will be continued for 60 minutes in the hyperthermic phase (41°C-43°C). HIPEC will be performed at the 1st, 3rd and 5th day after CRS. The intravenous chemotherapy(IVCT) will start from 7th-14th day after CRS.
PROCEDURECRS alone
Patients will undergo only CRS and IVCT.Patients will receive standard platinum-based combination doublet chemotherapy for 6-8 cycles after CRS and then followed by maintenance therapy.
Sponsors
CAI Hongbing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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 * informed consent form signed
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) * cardiac insufficiency or respiratory insufficiency * has received HIPEC already * being in other clinical study * pregnancy or lactation period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival | up to 36 months since diagnosis | The progression-free survival interval was the time between diagnosis and evidence of recurrent or progressive disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | up to 36 months since histological diagnosis | The overall survival interval was the time between diagnosis and death or last follow-up. |
| DP9 | the 1 day of histological diagnosis and 9 months after | The 9 months progression-free survival rate was the rate of no evidence of recurrent or progressive disease at the time of 9 months since histological diagnosis. |
| DP12 | the 1 day of histological diagnosis and 12 months after | The 9 months progression-free survival rate was the rate of no evidence of recurrent or progressive disease at the time of 12 months since histological diagnosis. |
| Serious adverse events, SAEs | surgery and with in 30 days | Serious adverse events occur within 30 days after surgery, measured with CTCAE 4.0 |
Countries
China
Contacts
Primary ContactHongbing Cai, Doctor
Backup ContactZhen Li, Doctor
Outcome results
None listed