A Randomized Prospective Trail of HIPEC in Recurrent Ovarian Cancer Patients With HRR Mutation
NCT ID: NCT04473339
Last Updated: 2020-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
280 participants
INTERVENTIONAL
2020-08-01
2023-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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HRR mt 1
Patients are HRR mutated type, will undergo CRS plus HIPEC and then go on to receive standard platinum-based combination doublet intravenous chemotherapy.
CRS+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.
HRR mt 2
Patients are HRR mutated type, will undergo CRS and then go on to receive standard platinum-based combination doublet intravenous chemotherapy.
CRS 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.
HRR wt 3
Patients are HRR wild type, will undergo CRS plus HIPEC and then go on to receive standard platinum-based combination doublet intravenous chemotherapy.
CRS+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.
HRR wt 4
Patients are HRR wild type, will undergo CRS and then go on to receive standard platinum-based combination doublet intravenous chemotherapy.
CRS 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.
Interventions
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CRS+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.
CRS 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
FEMALE
No
Sponsors
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CAI Hongbing
OTHER
Responsible Party
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CAI Hongbing
Dr. Prof.
Locations
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Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Countries
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Central Contacts
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Zhen Li, Doctor
Role: CONTACT
Facility Contacts
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Other Identifiers
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2020107
Identifier Type: -
Identifier Source: org_study_id
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