Ovarian CancerPhase 3NCT04473339
A Randomized Prospective Trail of HIPEC in Recurrent Ovarian Cancer Patients With HRR Mutation
A Phase 3 study testing CRS+HIPEC and CRS alone in people with Ovarian Cancer and Epithelial Ovarian Cancer, run by CAI Hongbing at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Ovarian Cancer, Epithelial Ovarian Cancer, Ovarian Cancer, Epithelial
- What is being tested?
- CRS+HIPEC and CRS alone
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2020to 30 Dec 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Zhen Li, Doctor contact
China1 site, 1 recruiting
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430070
Yuanzhen Zhang, Doctor, +86-27-67812787, znyyll@126.com
About this study
Official title: A Randomized Prospective Trail of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Recurrent Ovarian Cancer Patients With Mutations in Homologous Recombination Repair (HRR) Genes
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.
- Conditions
- Ovarian Cancer, Epithelial Ovarian Cancer, Ovarian Cancer, Epithelial, Hyperthermic Intraperitoneal Chemotherapy(HIPEC), Homologous Recombination Repair Gene Mutation
- Being tested
- CRS+HIPEC, CRS alone
- Keywords
- Homologous Recombination Repair Gene Mutation, hyperthermic intraperitoneal chemotherapy, Epithelial Ovarian Cancer
- Medical subject headings
- Ovarian Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRS+HIPECProcedure or surgery
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 aloneProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: CRS+HIPEC |
| 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. Receives: Procedure: CRS alone |
| 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. Receives: Procedure: CRS+HIPEC |
| 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. Receives: Procedure: CRS alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival
The progression-free survival interval was the time between diagnosis and evidence of recurrent or progressive disease.
Measured: up to 36 months since diagnosis
Secondary outcomes (4)
Overall Survival
The overall survival interval was the time between diagnosis and death or last follow-up.
Measured: 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.
Measured: 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.
Measured: 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
Measured: surgery and with in 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start1 Aug 2020
- Primary completion30 Aug 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CAI Hongbing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, CAI Hongbing, Zhongnan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04473339
- Sponsor's protocol ID
- 2020107
- Status last verified
- Jul 2020
- First submitted
- 12 Jul 2020
- Last updated
- 9 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Prospective Trail of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Recurrent Ovarian Cancer Patients With Mutations in Homologous Recombination Repair (HRR) Genes
- ClinicalTrials.gov ID
- NCT04473339
- Acronym / sponsor ID
- 2020107
- Conditions
- Ovarian Cancer, Epithelial Ovarian Cancer, Ovarian Cancer, Epithelial, Hyperthermic Intraperitoneal Chemotherapy(HIPEC), Homologous Recombination Repair Gene Mutation
- Keywords
- Homologous Recombination Repair Gene Mutation, hyperthermic intraperitoneal chemotherapy, Epithelial Ovarian Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- CAI HongbingUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 16 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HRR mt 1 | Experimental | Procedure: CRS+HIPECPatients 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 | Procedure: CRS alonePatients are HRR mutated type, will undergo CRS and then go on to receive standard platinum-based combination doublet intravenous chemotherapy. |
| HRR wt 3 | Experimental | Procedure: CRS+HIPECPatients 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 | Procedure: CRS alonePatients are HRR wild type, will undergo CRS and then go on to receive standard platinum-based combination doublet intravenous chemotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (14 listed)
- age < 18 or >75
- no history of other cancer
- platinum allergy
- distant metastasis
- used anti-angiogenic drug within 8 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRS+HIPECPatients 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. | Procedure or surgery | HRR mt 1, HRR wt 3 |
| CRS alonePatients 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. | Procedure or surgery | HRR mt 2, HRR wt 4 |
Primary outcome
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.
4 secondary outcomes
Overall Survival
Time frame: up to 36 months since histological diagnosis
DP9
Time frame: the 1 day of histological diagnosis and 9 months after
DP12
Time frame: the 1 day of histological diagnosis and 12 months after
Serious adverse events, SAEs
Time frame: surgery and with in 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhen Li, Doctor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CRS+HIPEC and CRS alone in people with Ovarian Cancer and Epithelial Ovarian Cancer, run by CAI Hongbing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongbing Cai, Doctor (+86-27-67812648, chb2105@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (time frame: up to 36 months since diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.