Epithelial Ovarian CancerPhase 3EHTASEOCCSNCT03373058
Efficacy of HIPEC in the Treatment of Advanced-Stage Epithelial Ovarian Cancer After Cytoreductive Surgery
A Phase 3 study testing Hyperthermic Intraperitoneal Chemotherapy, cytoreductive surgery and adjuvant chemotherapy in people with Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by Affiliated Cancer Hospital & Institute of Guangzhou Medical University at 7 sites in China.
Trial summary
This project is a multi-center, prospective, randomized controlled clinical observation the safety and efficacy of hyperthermic intraperitoneal chemotherapy in the treatment of advanced-stage epithelial ovarian cancer after cytoreductive surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
- What is being tested?
- Hyperthermic Intraperitoneal Chemotherapy, cytoreductive surgery and adjuvant chemotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 7 sitesChina
- Study dates
- 15 Oct 2019to 1 Jul 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Disease status primary epithelial ovarian cancer, tubal cancer, and primary peritoneal cancer (Stage III )
- Fagotti score by laparoscopic exploration < 6
- Residual tumor < 1cm after completion of cytoreductive surgery
- 18 < Age < 70 year old
- Expected survival > 3 months
- Performance status: ECOG 0-1
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- Adequate bone marrow function Hb ≥8 g/dl (After correction in case of iron deficient anemia) WBC ≥ 3,000/mm3, Platelet ≥ 100,000/mm3
- Adequate renal function Creatinine ≤ 1.5 mg/dl, and adequate hepatic function Bilirubin ≤ 1.5 mg/dl and AST and ALT ≤ 80 IU/L
- Voluntary participation after getting written informed consent.
Who cannot join
- Fagotti score by laparoscopic exploration >= 6
- Suboptimal debulking (residual tumor > 1cm)
- Extensive adhesion in peritoneal cavity
- Previous History of other malignancies (except excision of skin cancer, thyroid cancer)
- Poorly controlled disease e.g. atrial fibrillation, stenocardia, cardiac insufficiency, persistent hypertension despite medicinal treatment, ejection fraction<50%
- Receiving other chemotherapy, radiotherapy or immunotherapy
- Patients who are unsuitable candidates by doctor's decision
- Without given written informed consent
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing
Yunong Gao, MD, 010-88196216
Qian Li, MD
- Recruiting
Chongqing Cancer Hospital
Chongqing
Qi Zhou, MD, qizhou9128@163.com
Xingtao Long, MD
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing
Junying Tang, MD, tangjy_cqmu@sina.com
Lin Xiao, MD
- Recruiting
Affiliated Tumor Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510095
shuzhong cui, M.D, 0086-138-0251-3800, cuishuzhong@126.com
Zhen Tang, M.M, 0086-159-2081-9128, 57932181@qq.com
- Recruiting
Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Guanzhou, Guangdong, 510235
Zhongqiu Lin, MD, 08613802921545, lin-zhongqiu@163.com
Jing Li, MD
- Recruiting
Hubei General Hospital
Wuhan
LI Hong, MD, 1072247562@qq.com
- Recruiting
Henan Cancer Hospital
Zhengzhou
Li Wang, MD
About this study
Official title: A Phase III Multicenter Prospective Randomized Controlled Clinical Trial of Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Advanced-Stage Epithelial Ovarian Cancer After Cytoreductive Surgery
This project is a multi-center, prospective, randomized controlled clinical observation the safety and efficacy of hyperthermic intraperitoneal chemotherapy in the treatment of advanced-stage epithelial ovarian cancer after cytoreductive surgery. Median recurrence-free survival is the primary end points of this project.
Read the detailed description
The current standard treatment for epithelial ovarian cancer, tubal cancer, and primary peritoneal cancer is maximal cytoreductive surgery followed by intravenous chemotherapy with or without intraperitoneal chemotherapy (IP). Recently, the organizations of SGO and ASCO recommended that women with Fagotti score by laparoscopic exploration < 6 would benefit from primary cytoreductive surgery followed by postoperative chemotherapy, and are likely to attain optimal cytoreduction (residual lesion ≤ 1 cm).
Hyperthermia promotes chemotherapy to penetrate deeper into the cancer tissue. Therefore, hyperthermic intraperitoneal chemotherapy (HIPEC) as newly postoperative chemotherapy after primary cytoreductive surgery in the treatment of ovarian cancer could lead to higher response rate and better survival outcomes.
- Being tested
- Hyperthermic Intraperitoneal Chemotherapy, cytoreductive surgery, adjuvant chemotherapy
- Keywords
- Hyperthermic Intraperitoneal Chemotherapy, Advanced-Stage Epithelial Ovarian Cancer, Cytoreductive surgery, Postoperative Chemotherapy
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Fallopian Tube 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
Also called HIPEC
HIPEC is performed as postoperative chemotherapy after cytoreductive surgery for advanced-stage epithelial ovarian cancer. The first HIPEC is conducted within 48h after cytoreductive surgery: Paclitaxel 175 mg/m^2, 43°C, 90min. The second HIPEC is performed after 48 hours of the first HIPEC. The HIPEC regimens are Docetaxel 75 mg/m^2 and cisplatin 75 mg/m^2, respectively, 43°C, 90min.
cytoreductive surgeryProcedure or surgery
Also called CRS
Cytoreductive surgery (CRS) is performed when Faggoti value is less than 6 via laparoscopic exploration.
adjuvant chemotherapyDrug
Also called ACT
Systemic chemotherapy regimens after HIPEC treatment are paclitaxel 175 mg/m^2 IV>3 hour+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks for 2 cycles in experimental group.
Systemic chemotherapy regimens after IDS are paclitaxel 175 mg/m^2 IV>3 hour+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks for 3 cycles in control group.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 1. Cytoreductive surgery
2. Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Docetaxel 75 mg/m^2 and cisplatin 75 mg/m^2 intraperitoneally in succession
3. 6 cycles of adjuvant chemotherapy: paclitaxel 175 mg/m^2 IV>3 hour(Docetaxel 75 mg/m^2, if paclitaxel is not available.)+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks. Receives: Procedure: Hyperthermic Intraperitoneal Chemotherapy; Procedure: cytoreductive surgery; Drug: adjuvant chemotherapy |
| Control group | Active comparator | 1. Cytoreductive surgery
2. 6 cycles of adjuvant chemotherapy: paclitaxel 175 mg/m^2 IV>3 hour(Docetaxel 75 mg/m^2, if paclitaxel is not available)+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks. Receives: Procedure: cytoreductive surgery; Drug: adjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median recurrence-free survival
assess median recurrence-free survival during 3 years in both study arms
Measured: 3 years
Secondary outcomes (4)
Median overall survival
assess median overall survival during 3 years in both study arms
Measured: 3 years
Median progression-free survival
assess median progression-free survival during 3 years in both study arms
Measured: 3 years
Risk factors for morbidity and mortality
The early complication and mortality are defined as the event observed within 30 days after intervention, while the time frame for late complication is the period beyond 30 days after intervention to the end of 3 years. Complications are ranked from grade 0-5 according to CTCAE V4.0
Measured: 30 days; 3 years
Quality of life for ovarian cancer
Evaluated according to European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Ovarian Cancer Module (QLQ-OV28)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study start15 Oct 2019
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial 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
- None (open label)
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Cancer Hospital & Institute of Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University, Henan Provincial People's Hospital, Xiangya Hospital of Central South University, The Third Xiangya Hospital of Central South University, Peking University Cancer Hospital & Institute, Peking University People's Hospital, Cancer Hospital of Guizhou Province, Chinese PLA General Hospital, Hebei Medical University Fourth Hospital, The Second Hospital of Hebei Medical University, West China Second University Hospital, Peking Union Medical College Hospital, First Affiliated Hospital, Sun Yat-Sen University, Henan Cancer Hospital, Tianjin Medical University Cancer Institute and Hospital, The Third Affiliated Hospital of Guangzhou Medical University, Wuhan University, RenJi Hospital, Obstetrics & Gynecology Hospital of Fudan University, Southern Medical University, China, Fourth Affiliated Hospital of Guangxi Medical University, Shandong Cancer Hospital and Institute, Beijing Obstetrics and Gynecology Hospital, Chongqing University Cancer Hospital, Xinqiao Hospital of Chongqing, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, First Affiliated Hospital of Chongqing Medical University, Affiliated Cancer Hospital of Shantou University Medical College
- Responsible party
- Sponsor
- Investigators
- Shuzhong Cui, M.D, Study director, Affiliated Cancer Hospital & Institute of Guangzhou Medical UniversityZhongqiu Lin, M.D, Study director, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03373058
- Sponsor's protocol ID
- HIPEC-03
- Acronym
- EHTASEOCCS
- Status last verified
- Nov 2019
- First submitted
- 4 Dec 2017
- Last updated
- 6 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Multicenter Prospective Randomized Controlled Clinical Trial of Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Advanced-Stage Epithelial Ovarian Cancer After Cytoreductive Surgery
- ClinicalTrials.gov ID
- NCT03373058
- Acronym / sponsor ID
- EHTASEOCCS / HIPEC-03
- Keywords
- Hyperthermic Intraperitoneal Chemotherapy, Advanced-Stage Epithelial Ovarian Cancer, Cytoreductive surgery, Postoperative Chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Affiliated Cancer Hospital & Institute of Guangzhou Medical UniversityUniversity, hospital or other
- Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University, Henan Provincial People's Hospital, Xiangya Hospital of Central South University, The Third Xiangya Hospital of Central South University, Peking University Cancer Hospital & Institute, Peking University People's Hospital, Cancer Hospital of Guizhou Province, Chinese PLA General Hospital, Hebei Medical University Fourth Hospital, The Second Hospital of Hebei Medical University, West China Second University Hospital, Peking Union Medical College Hospital, First Affiliated Hospital, Sun Yat-Sen University, Henan Cancer Hospital, Tianjin Medical University Cancer Institute and Hospital, The Third Affiliated Hospital of Guangzhou Medical University, Wuhan University, RenJi Hospital, Obstetrics & Gynecology Hospital of Fudan University, Southern Medical University, China, Fourth Affiliated Hospital of Guangxi Medical University, Shandong Cancer Hospital and Institute, Beijing Obstetrics and Gynecology Hospital, Chongqing University Cancer Hospital, Xinqiao Hospital of Chongqing, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, First Affiliated Hospital of Chongqing Medical University, Affiliated Cancer Hospital of Shantou University Medical College
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 14 Dec 2017 (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 project is a multi-center, prospective, randomized controlled clinical observation the safety and efficacy of hyperthermic intraperitoneal chemotherapy in the treatment of advanced-stage epithelial ovarian cancer after cytoreductive surgery. Median recurrence-free survival is the primary end points of this project.
Detailed description
The current standard treatment for epithelial ovarian cancer, tubal cancer, and primary peritoneal cancer is maximal cytoreductive surgery followed by intravenous chemotherapy with or without intraperitoneal chemotherapy (IP). Recently, the organizations of SGO and ASCO recommended that women with Fagotti score by laparoscopic exploration < 6 would benefit from primary cytoreductive surgery followed by postoperative chemotherapy, and are likely to attain optimal cytoreduction (residual lesion ≤ 1 cm).
Hyperthermia promotes chemotherapy to penetrate deeper into the cancer tissue. Therefore, hyperthermic intraperitoneal chemotherapy (HIPEC) as newly postoperative chemotherapy after primary cytoreductive surgery in the treatment of ovarian cancer could lead to higher response rate and better survival outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Procedure: Hyperthermic Intraperitoneal Chemotherapy, Procedure: cytoreductive surgery, Drug: adjuvant chemotherapy1. Cytoreductive surgery 2. Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Docetaxel 75 mg/m^2 and cisplatin 75 mg/m^2 intraperitoneally in succession 3. 6 cycles of adjuvant chemotherapy: paclitaxel 175 mg/m^2 IV>3 hour(Docetaxel 75 mg/m^2, if paclitaxel is not available.)+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks. |
| Control group | Active comparator | Procedure: cytoreductive surgery, Drug: adjuvant chemotherapy1. Cytoreductive surgery 2. 6 cycles of adjuvant chemotherapy: paclitaxel 175 mg/m^2 IV>3 hour(Docetaxel 75 mg/m^2, if paclitaxel is not available)+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks. |
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)
- Disease status primary epithelial ovarian cancer, tubal cancer, and primary peritoneal cancer (Stage III )
- Fagotti score by laparoscopic exploration < 6
- Residual tumor < 1cm after completion of cytoreductive surgery
- 18 < Age < 70 year old
- Expected survival > 3 months
Key exclusion criteria (8 listed)
- Fagotti score by laparoscopic exploration >= 6
- Suboptimal debulking (residual tumor > 1cm)
- Extensive adhesion in peritoneal cavity
- Previous History of other malignancies (except excision of skin cancer, thyroid cancer)
- Poorly controlled disease e.g. atrial fibrillation, stenocardia, cardiac insufficiency, persistent hypertension despite medicinal treatment, ejection fraction<50%
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 ChemotherapyAlso: HIPECHIPEC is performed as postoperative chemotherapy after cytoreductive surgery for advanced-stage epithelial ovarian cancer. The first HIPEC is conducted within 48h after cytoreductive surgery: Paclitaxel 175 mg/m^2, 43°C, 90min. The second HIPEC is performed after 48 hours of the first HIPEC. The HIPEC regimens are Docetaxel 75 mg/m^2 and cisplatin 75 mg/m^2, respectively, 43°C, 90min. | Procedure or surgery | Experimental group |
| cytoreductive surgeryAlso: CRSCytoreductive surgery (CRS) is performed when Faggoti value is less than 6 via laparoscopic exploration. | Procedure or surgery | Control group, Experimental group |
| adjuvant chemotherapyAlso: ACTSystemic chemotherapy regimens after HIPEC treatment are paclitaxel 175 mg/m^2 IV>3 hour+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks for 2 cycles in experimental group. Systemic chemotherapy regimens after IDS are paclitaxel 175 mg/m^2 IV>3 hour+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks for 3 cycles in control group. | Drug | Control group, Experimental group |
Primary outcome
Median recurrence-free survival
Time frame: 3 years
assess median recurrence-free survival during 3 years in both study arms
4 secondary outcomes
Median overall survival
Time frame: 3 years
Median progression-free survival
Time frame: 3 years
Risk factors for morbidity and mortality
Time frame: 30 days; 3 years
Quality of life for ovarian cancer
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2019.
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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.
Shuzhong Cui, M.D study director
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Zhongqiu Lin, M.D study director
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hyperthermic Intraperitoneal Chemotherapy, cytoreductive surgery and adjuvant chemotherapy in people with Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by Affiliated Cancer Hospital & Institute of Guangzhou Medical University at 7 sites 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 8 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 6 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 Shuzhong Cui, M.D (0086-138-0251-3800, cuishuzhong@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median recurrence-free survival (time frame: 3 years). 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 6 Nov 2019.