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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRR mt 1 | Experimental | Patients are HRR mutated type, will undergo CRS plus HIPEC and then go on to receive standard platinum-based combination doublet intravenous chemotherapy. |
|
| HRR mt 2 | Experimental | Patients are HRR mutated type, will undergo CRS and then go on to receive standard platinum-based combination doublet intravenous chemotherapy. |
|
| HRR wt 3 | Experimental | Patients are HRR wild type, will undergo CRS plus HIPEC and then go on to receive standard platinum-based combination doublet intravenous chemotherapy. |
|
| HRR wt 4 | Experimental | Patients are HRR wild type, will undergo CRS and then go on to receive standard platinum-based combination doublet intravenous chemotherapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRS+HIPEC | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | The progression-free survival interval was the time between diagnosis and evidence of recurrent or progressive disease. | up to 36 months since diagnosis |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | The overall survival interval was the time between diagnosis and death or last follow-up. | up to 36 months since histological diagnosis |
| DP9 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongbing Cai, Doctor | Contact | +86-27-67812648 | chb2105@163.com | |
| Zhen Li, Doctor | Contact | +86-27-67812648 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongnan Hospital of Wuhan University | Recruiting | Wuhan | Hubei | 430070 | China |
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| CRS alone | Procedure | 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. |
|
| the 1 day of histological diagnosis and 9 months after |
| DP12 | 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. | the 1 day of histological diagnosis and 12 months after |
| Serious adverse events, SAEs | Serious adverse events occur within 30 days after surgery, measured with CTCAE 4.0 | surgery and with in 30 days |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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