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Ovarian CancerPhase 3HIPECOVNCT03371693

Cytoreductive Surgery(CRS) Plus Hyperthermic Intraperitoneal Chemotherapy(HIPEC) With Lobaplatin in Advanced and Recurrent Epithelial Ovarian Cancer

A Phase 3 study testing HIPEC, CRS and IVCT in people with Ovarian Cancer and Ovary Neoplasm, run by Zhongnan Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A phase III prospective study with the primary objective to compare the efficacy and safety of HIPEC( Hyperthermic Intraperitoneal Chemotherapy). The target population for this study is patients with primary or recurrence ovarian, peritoneal or fallopian tube cancers undergoing CRS( Cytoreductive Surgery). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Ovarian Cancer, Ovary Neoplasm, Ovarian Neoplasms
What is being tested?
HIPEC, CRS and IVCT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
1 siteChina
Study dates
30 Sep 2017to 30 Mar 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
  • All sexes
  • 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

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.

China1 site

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430072

Other trials in China

About this study

Official title: A Phase III Clinical Trail of Cytoreductive Surgery(CRS) Plus Hyperthermic Intraperitoneal Chemotherapy(HIPEC) With Lobaplatin in Advanced and Recurrent Epithelial Ovarian Cancer

A phase III prospective study with the primary objective to compare the efficacy and safety of HIPEC( Hyperthermic Intraperitoneal Chemotherapy). The target population for this study is patients with primary or recurrence ovarian, peritoneal or fallopian tube cancers undergoing CRS( Cytoreductive Surgery). Patients will be divided into two groups. Group A will undergo CRS plus HIPEC and then go on to receive standard platinum-based combination doublet intravenous chemotherapy. Group B will undergo CRS and then go on to intravenous chemotherapy.

Read the detailed description

This is a phase III prospective study with the primary objective to compare the efficacy and safety of HIPEC. The target population for this study is patients with primary or recurrence ovarian, peritoneal or fallopian tube cancers undergoing CRS. 'Platinum-sensitive' recurrence is defined as recurrence 6 months after the completion of the primary platinum-based chemotherapy. A single dose of lobaplatin 40mg/m2 will be administered via HIPEC , and will be administered at the time of surgery, 3 days after surgery and 5 days after surgery. Patients of group A will undergo CRS plus HIPEC and then go on to receive standard platinum-based combination doublet intravenous chemotherapy (carboplatin and paclitaxel, carboplatin and gemcitabine, or carboplatin and liposomal doxorubicin) for 6 cycles. Patients of group B will undergo CRS and then go on to intravenous chemotherapy.

Being tested
HIPEC, CRS, IVCT
Keywords
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.

  • HIPECDevice

    Patients consenting to this protocol will undergo their scheduled surgical procedure. After cytoreductive surgery (CRS) to a residual disease ≤ 2.5 mm, a single dose of lobaplatin (30 mg/m2) will be administered in normal saline via intraperitoneal hyperthermic perfusion using the closed-abdomen technique. HIPEC will be continued for 60 minutes in the hyperthermic phase (43℃±0.5℃). And HIPEC will be repeated at the 3 and 5 day after the day of CRS plus HIPEC.

  • CRSDevice

    cytoreductive surgery (CRS) to a residual disease ≤ 2.5 mm.

  • IVCTDevice

    platinum-based intravenous chemotherapy

Study groups in NCT03371693
Study groupRoleWhat they receive
HIPECExperimentalPatients will undergo a CRS plus HIPEC and IVCT. Hyperthermic intraperitoneal chemotherapy (HIPEC) is a procedure in which the abdominal cavity is bathed in a warm solution of anti-cancer medications for 60 minutes. 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.
Receives: Device: HIPEC; Device: CRS; Device: IVCT
Non HIPECOtherPatients will undergo only CRS and IVCT. Patients will receive standard platinum-based combination doublet chemotherapy for 6-8 cycles after CRS.
Receives: Device: CRS; Device: IVCT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival rate

    assess overall survival rate in 5 years in both arms

    Measured: 5 years

  2. 1 year survival rate

    assess the survival rate in 1 year for both arms

    Measured: 1 year

  3. 3 year survival rate

    assess the survival rate in 3 years for both arms

    Measured: 3 years

Secondary outcomes (3)

  1. Progression-free survival

    assess the Progression-free survival rate during 5 years for both study arms

    Measured: 5 years

  2. quality of life

    Patients will fill the EORTC Quality of life questionaire-C30 form to measure the quality of life after a standard treatment.

    Measured: 5 years after CRS or until death

  3. postoperative complication

    measured with physical examination and/or computed tomography（CT）and/or ultrasound examination.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2017
  2. Study start30 Sep 2017
  3. Primary completion30 Dec 2022 (estimated)
  4. Study completion30 Mar 2023 (estimated)

Resources

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
None (open label)
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03371693
Sponsor's protocol ID
HIPECOV
Acronym
HIPECOV
Status last verified
May 2020
First submitted
27 Nov 2017
Last updated
29 May 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HIPEC, CRS and IVCT in people with Ovarian Cancer and Ovary Neoplasm, run by Zhongnan Hospital 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 10 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 29 May 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival rate (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03371693.

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 29 May 2020.

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