Ovarian CancerNCT04280185
HIPEC in the Treatment of Stage IIc-IV Epithelial Ovarian Cancer After CRS (HIPECOC)
A study testing Hyperthermic Intraperitoneal Chemotherapy in people with Ovarian Cancer and Hyperthermic Intraperitoneal Chemotherapy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This study evaluate the Hyperthermic Intraperitoneal Chemotherapy(HIPEC) in the treatment of Stage IIc-IV epithelial Ovarian Cancer after primary Cytoreductive Surgery (CRS).Half participants will receive HIPEC twice with one intravenous chemotherapy and 5 cycles of intravenous chemotherapy with carboplatin and… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Ovarian Cancer, Hyperthermic Intraperitoneal Chemotherapy
- What is being tested?
- Hyperthermic Intraperitoneal Chemotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2020to 1 May 2024
- Phase
- Interventional
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the patient voluntarily joined the study and signed the consent form;
- female patients aged between 18 and 70 who are not pregnant or lactating;
- primary epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer were diagnosed at the time of diagnosis, and no chemotherapy or radiotherapy was given within three months before the study began;
- laparoscopic Fagotti score <6;
- residual lesions in abdominal cavity after tumor cell extinction <1cm;
- expected survival time ≥12 weeks;
Show all 9Show fewer
- ECOG score: 0-1;
- bone marrow reserve function is good, and blood routine indexes meet the following requirements: white blood cell count ≥3.0×109/L, neutrophil absolute count ≥1.5×109/L, platelet count ≥100×109/L, hemoglobin ≥90 g/L;
- important organs function well and blood biochemical indexes meet the following requirements: serum albumin ≥30 g/L, ALT≤2.5× normal upper limit (ULN), AST≤2.5×ULN, serum total bilirubin ≤1.5×ULN, serum creatinine ≤1.5×ULN.
Who cannot join
- refuse to sign the informed consent;
- other malignant tumors in the past 5 years or at the same time, except cured basal cell carcinoma of skin, cervical carcinoma in situ, thyroid papillary carcinoma and breast cancer without recurrence 3 years after radical resection;
- laparoscopic Fagotti score ≥6;
- extensive adhesion exists in the abdominal cavity.
- >1cm of residual lesions in the abdominal cavity after tumor cell extinction;
- patients with previous gastrointestinal perforation, abdominal abscess or recent intestinal obstruction (within 3 months), or with imaging and clinical symptoms indicating intestinal obstruction;
Show all 13Show fewer
- suffer from other difficult to control serious diseases, including uncontrolled hypertension, NYHA grade 2 or above heart failure, unstable angina, atrial fibrillation, myocardial infarction (within the previous 1 year), renal insufficiency, uncontrollable infection, etc.;
- significant clinically significant bleeding symptoms and abnormal coagulation function (INR>2.0 or prothrombin time >16s) within the previous 3 months, with a clear tendency to bleeding or being treated with thrombolysis or anticoagulant therapy;
- occurrence of thrombotic events in the past six months, such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism;
- congenital or acquired immune deficiency;
- with active hepatitis, active ulcer, unhealed wound or fracture;
- being treated with other anticancer drugs;
- the investigator assessed and determined that there were any other unstable conditions, including alcohol abuse, drug abuse, other family or social factors, that might affect patient safety and compliance or cause the study to be discontinued.
Trial locations and contacts
1 site in 1 country.
JIONG MA contact
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital, Zhejiang University, School Of Medicine
Hangzhou, Zhejiang, 310009
XUEJUN CHEN, Doctor, 2303011@zju.edu.cn
About this study
Official title: Multicenter Prospective Randomized Controlled Clinical Trial of Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Stage IIc-IV Epithelial Ovarian Cancer After Primary Cytoreductive Surgery
This study evaluate the Hyperthermic Intraperitoneal Chemotherapy(HIPEC) in the treatment of Stage IIc-IV epithelial Ovarian Cancer after primary Cytoreductive Surgery (CRS).Half participants will receive HIPEC twice with one intravenous chemotherapy and 5 cycles of intravenous chemotherapy with carboplatin and paclitaxel after CRS. Half participants will receive 6 cycles of intravenous chemotherapy with carboplatin and paclitaxel after CRS.
Read the detailed description
Advanced epithelial ovarian cancer, now recognized as the most effective treatment is maximizing tumor reduction (cytoreductice surgery, CRS) within the abdominal cavity with platinum-based chemotherapy (intraperitoneal chemotherapy, IPEC) or intravenous chemotherapy.
Hyperthermic intraperitoneal chemotherapy (HIPEC) refers to the chemotherapy drugs will be diluted and heated to the specified temperature (usually the 42 degrees), then injected into the abdominal cavity, maintain a constant temperature, repeated perfusion filling, so as to achieve the purpose of prevention and treatment of intra-abdominal tumors of a way of treatment.
CRS combined with HIPEC is the most effective treatment strategy for peritoneal cancer at present.
- Being tested
- Hyperthermic Intraperitoneal Chemotherapy
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperthermic Intraperitoneal ChemotherapyProcedure or surgery
HIPEC is a way of intraperitoneal chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Hyperthermic Intraperitoneal chemotherapy | Experimental | Hyperthermic Intraperitoneal chemotherapy was started immediately after CRS, or the first HIPEC was completed within 48 hours after surgery: temperature 43℃, duration 60 minutes, Paclitaxel (60mg/m2) was selected. The second HIEPC was completed 7 days after the first HIPEC: temperature 43℃, duration 60min, carboplatin AUC (5-6) was selected. 30 minutes before using Paclitaxel, 10ML saline + 10mg dexamethasone intravenous infusion, 20mg diphenhyramine intramuscular injection, and 100ML saline + 0.3g cimetidine intravenous infusion. On the eighth day, intravenous chemotherapy with Paclitaxel (135mg/m2) was finally completed. 5 courses of TC intravenous chemotherapy were performed after 3 weeks Receives: Procedure: Hyperthermic Intraperitoneal Chemotherapy |
| intravenous chemotherapy | No intervention | intravenous chemotherapy were performed 6 Cycles after CRS. Paclitaxel: 175mg/m2, iv infusion, no less than 3h per infusion, followed by carboplatin: AUC 5-6, iv infusion, no less than 1h per infusion, 1 dose on the first day of a week, 1 cycle every 3 weeks, a total of 6 cycles. Paclitaxel should be pretreated to prevent severe allergic reactions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the progression-free survival (PFS) of patients with advanced ovarian cancer undergoing primary tumor cell depletion (HIPEC) during surgery.
From the date of random enrollment to the date of tumor progression or death. The appearance of the new lesion was taken as the criterion of progression, and the date of the first measurable observation of the new lesion was the marker of progression.ovarian cancer undergoing primary tumor cell depletion (HIPEC) during surgery.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start1 Jun 2020 (estimated)
- Primary completion1 May 2022 (estimated)
- Study completion1 May 2024 (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.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 202 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang University
- Responsible party
- Sponsor
- Investigators
- JIONG MA, Principal investigator, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04280185
- Sponsor's protocol ID
- cxj2019001434
- Status last verified
- Oct 2019
- First submitted
- 15 Oct 2019
- Last updated
- 18 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Randomized Controlled Clinical Trial of Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Stage IIc-IV Epithelial Ovarian Cancer After Primary Cytoreductive Surgery
- ClinicalTrials.gov ID
- NCT04280185
- Acronym / sponsor ID
- cxj2019001434
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 202 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Zhejiang University
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 21 Feb 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.
This study evaluate the Hyperthermic Intraperitoneal Chemotherapy(HIPEC) in the treatment of Stage IIc-IV epithelial Ovarian Cancer after primary Cytoreductive Surgery (CRS).Half participants will receive HIPEC twice with one intravenous chemotherapy and 5 cycles of intravenous chemotherapy with carboplatin and paclitaxel after CRS. Half participants will receive 6 cycles of intravenous chemotherapy with carboplatin and paclitaxel after CRS.
Detailed description
Advanced epithelial ovarian cancer, now recognized as the most effective treatment is maximizing tumor reduction (cytoreductice surgery, CRS) within the abdominal cavity with platinum-based chemotherapy (intraperitoneal chemotherapy, IPEC) or intravenous chemotherapy.
Hyperthermic intraperitoneal chemotherapy (HIPEC) refers to the chemotherapy drugs will be diluted and heated to the specified temperature (usually the 42 degrees), then injected into the abdominal cavity, maintain a constant temperature, repeated perfusion filling, so as to achieve the purpose of prevention and treatment of intra-abdominal tumors of a way of treatment.
CRS combined with HIPEC is the most effective treatment strategy for peritoneal cancer at present.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperthermic Intraperitoneal chemotherapy | Experimental | Procedure: Hyperthermic Intraperitoneal ChemotherapyHyperthermic Intraperitoneal chemotherapy was started immediately after CRS, or the first HIPEC was completed within 48 hours after surgery: temperature 43℃, duration 60 minutes, Paclitaxel (60mg/m2) was selected. The second HIEPC was completed 7 days after the first HIPEC: temperature 43℃, duration 60min, carboplatin AUC (5-6) was selected. 30 minutes before using Paclitaxel, 10ML saline + 10mg dexamethasone intravenous infusion, 20mg diphenhyramine intramuscular injection, and 100ML saline + 0.3g cimetidine intravenous infusion. On the eighth day, intravenous chemotherapy with Paclitaxel (135mg/m2) was finally completed. 5 courses of TC intravenous chemotherapy were performed after 3 weeks |
| intravenous chemotherapy | No intervention | –intravenous chemotherapy were performed 6 Cycles after CRS. Paclitaxel: 175mg/m2, iv infusion, no less than 3h per infusion, followed by carboplatin: AUC 5-6, iv infusion, no less than 1h per infusion, 1 dose on the first day of a week, 1 cycle every 3 weeks, a total of 6 cycles. Paclitaxel should be pretreated to prevent severe allergic reactions. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- the patient voluntarily joined the study and signed the consent form;
- female patients aged between 18 and 70 who are not pregnant or lactating;
- primary epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer were diagnosed at the time of diagnosis, and no chemotherapy or radiotherapy was given within three months before the study began;
- laparoscopic Fagotti score <6;
- residual lesions in abdominal cavity after tumor cell extinction <1cm;
Key exclusion criteria (13 listed)
- refuse to sign the informed consent;
- other malignant tumors in the past 5 years or at the same time, except cured basal cell carcinoma of skin, cervical carcinoma in situ, thyroid papillary carcinoma and breast cancer without recurrence 3 years after radical resection;
- laparoscopic Fagotti score ≥6;
- extensive adhesion exists in the abdominal cavity.
- >1cm of residual lesions in the abdominal cavity after tumor cell extinction;
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 |
|---|---|---|
| Hyperthermic Intraperitoneal ChemotherapyHIPEC is a way of intraperitoneal chemotherapy | Procedure or surgery | Hyperthermic Intraperitoneal chemotherapy |
Primary outcome
To evaluate the progression-free survival (PFS) of patients with advanced ovarian cancer undergoing primary tumor cell depletion (HIPEC) during surgery.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
From the date of random enrollment to the date of tumor progression or death. The appearance of the new lesion was taken as the criterion of progression, and the date of the first measurable observation of the new lesion was the marker of progression.ovarian cancer undergoing primary tumor cell depletion (HIPEC) during surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2020.
- Individual participant dataSharing planned: No
Related trials for Ovarian Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
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.
JIONG MA contact
JIONG MA principal investigator
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperthermic Intraperitoneal Chemotherapy in people with Ovarian Cancer and Hyperthermic Intraperitoneal Chemotherapy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 9 inclusion and 13 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 18 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.
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 XUEJUN CHEN (+86 0571 87783738, 2303011@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the progression-free survival (PFS) of patients with advanced ovarian cancer undergoing primary tumor cell depletion (HIPEC) during surgery. (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months). 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 18 May 2020.