Epithelial Ovarian CancerPhase 3EHNPCTASEOCNCT03180177
Efficacy of HIPEC as NACT and Postoperative Chemotherapy in the Treatment of Advanced-Stage Epithelial Ovarian Cancer
A Phase 3 study testing Hyperthermic Intraperitoneal Chemotherapy, Interval debulking surgery and neoadjuvant chemotherapy in people with Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by Shu-Zhong Cui at 1 site in China.
Trial summary
This project is a multi-center, prospective, randomized controlled clinical observation the safety and efficacy of hyperthermic intraperitoneal chemotherapy as neoadjuvant chemotherapy(NACT) and postoperative chemotherapy after interval debulking surgery (IDS) for advanced-stage epithelial ovarian cancer . 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, Interval debulking surgery and neoadjuvant chemotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 263 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2018to 1 Jul 2022
- 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 and IV)
- Fagotti score by laparoscopic exploration >= 6
- After receiving HIPEC+neoadjuvant chemotherapy (NACT) or NACT alone, the curative effects evaluated according to RICIST criteria is partial remission (PR) and stable disease (SD).
- Residual tumor < 1cm after completion of interval debulking surgery
- 18 < Age < 70 year old
- Expected survival > 3 months
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- Performance status: ECOG 0-1
- 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
- After receiving HIPEC+neoadjuvant chemotherapy (NACT) or NACT alone, the progression of disease (PD) is evaluated by doctor.
- 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%
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- Receiving other chemotherapy, radiotherapy or immunotherapy
- Patients who are unsuitable candidates by doctor's decision
- Without given written informed consent
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Abdominal Surgery (Section 2), Affiliated Tumor Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510095
shuzhong cui, M.D, 0086-138-0251-3800, cuishuzhong@126.com
Xianzi Yang, M.D, 0086-188-9853-4167, 7097359@qq.com
About this study
Official title: A Phase III Multicenter Prospective Randomized Controlled Clinical Trial of HIPEC as NACT and Postoperative Chemotherapy After Interval Debulking Surgery in the Treatment of Advanced-Stage Epithelial Ovarian Cancer
This project is a multi-center, prospective, randomized controlled clinical observation the safety and efficacy of hyperthermic intraperitoneal chemotherapy as neoadjuvant chemotherapy(NACT) and postoperative chemotherapy after interval debulking surgery (IDS) for advanced-stage epithelial ovarian cancer . PR/SD rate, percentage of optimal debulking surgery and 3-year disease-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 a high perioperative risk profile or a low likelihood of achieving cytoreduction to < 1 cm of residual disease (ideally to novisible disease) should receive neoadjuvant chemotherapy.
Hyperthermia promotes chemotherapy to penetrate deeper into the cancer tissue. Therefore, hyperthermic intraperitoneal chemotherapy (HIPEC) as neoadjuvant chemotherapy and postoperative chemotherapy after interval debulking surgery in the treatment of ovarian cancer could lead to higher response rate and better survival outcomes.
- Being tested
- Hyperthermic Intraperitoneal Chemotherapy, Interval debulking surgery, neoadjuvant chemotherapy, adjuvant chemotherapy
- Keywords
- Hyperthermic Intraperitoneal Chemotherapy, Neoadjuvant Chemotherapy, Interval Debulking Surgery, Advanced-Stage Epithelial Ovarian Cancer, 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 neoadjuvant chemotherapy(NACT) and postoperative chemotherapy after interval debulking surgery (IDS) for advanced-stage epithelial ovarian cancer. The first HIPEC is conducted within 24h after laparoscopic exploration or Interval debulking surgery: Paclitaxel 175 mg/m^2, 43°C, 90min. The second HIPEC is performed after 48 hours of the first HIPEC. The second HIPEC regimens are cisplatin 75 mg/m^2, 43°C, 90min.
Interval debulking surgeryProcedure or surgery
Also called IDS
Cytoreductive surgery (CRS) is performed after neoadjuvant chemotherapy.
neoadjuvant chemotherapyDrug
Also called NACT
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 laparoscopic exploration 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.
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. Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with paclitaxel 175 mg/m^2 and cisplatin 75 mg/m^2 intraperitoneally in succession
2. 2 cycles of neoadjuvant chemotherapy: paclitaxel 175 mg/m^2 IV>3 hour+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks
3. Interval debulking surgery
4. Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with paclitaxel 175 mg/m^2 and cisplatin 75 mg/m^2 intraperitoneally in succession
5. 2 cycles of adjuvant chemotherapy: paclitaxel 175 mg/m^2 IV>3 hour+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks Receives: Procedure: Hyperthermic Intraperitoneal Chemotherapy; Procedure: Interval debulking surgery; Drug: neoadjuvant chemotherapy; Drug: adjuvant chemotherapy |
| Control group | Active comparator | 1. 3 cycles of neoadjuvant chemotherapy: paclitaxel 175 mg/m^2 IV>3 hour+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks
2. Interval debulking surgery
3. 3 cycles of adjuvant chemotherapy: paclitaxel 175 mg/m^2 IV>3 hour+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks Receives: Procedure: Interval debulking surgery; Drug: neoadjuvant chemotherapy; Drug: adjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PR/SD rate
calculate the percent of partial remission (PR) plus stable disease (SD) of patients received HIPEC+NACT or NACT alone in both two arms
Measured: Through study completion, an average of 1 year
Percentage of optimal debulking surgery
evaluate the percentage of optimal debulk (residual disease < 1cm) after interval debulking surgery between study arms
Measured: Through study completion, an average of 1 year
Disease-free survival rate
assess disease free survival rate during 3 years in both study arms
Measured: 3 years
Secondary outcomes (4)
Overall survival rate
assess overall survival rate during 3 years in both study arms
Measured: 3 years
Risk factors for morbidity and mortality
determine percent of patients wtih Grade I-IV adverse events according to NCI criteria, Common Terminology Criteria for AE (CTCAE 4.0).
Measured: Through study completion, an average of 1 year
Quality of life
Evaluated according to European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Cancer (EORTC QLQ-C30)
Measured: 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 posted8 Jun 2017
- Study start1 Mar 2018 (estimated)
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Jul 2022 (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
- Single blind
- Who is masked
- Participant
- Enrolment
- 263 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shu-Zhong Cui
- 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 Cancer Institute, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Xinqiao Hospital of Chongqing
- Responsible party
- Sponsor-investigator, Shu-Zhong Cui, Affiliated Cancer Hospital & Institute of Guangzhou Medical University
- 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
- NCT03180177
- Sponsor's protocol ID
- HIPEC-03
- Acronym
- EHNPCTASEOC
- Status last verified
- Jan 2018
- First submitted
- 6 Jun 2017
- Last updated
- 24 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 Jan 2018. 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 HIPEC as NACT and Postoperative Chemotherapy After Interval Debulking Surgery in the Treatment of Advanced-Stage Epithelial Ovarian Cancer
- ClinicalTrials.gov ID
- NCT03180177
- Acronym / sponsor ID
- EHNPCTASEOC / HIPEC-03
- Keywords
- Hyperthermic Intraperitoneal Chemotherapy, Neoadjuvant Chemotherapy, Interval Debulking Surgery, Advanced-Stage Epithelial Ovarian Cancer, Postoperative Chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 263 participants (estimated)
- Lead sponsor
- Shu-Zhong CuiUniversity, 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 Cancer Institute, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Xinqiao Hospital of Chongqing
- Study start
- 1 Mar 2018 (estimated)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 8 Jun 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 as neoadjuvant chemotherapy(NACT) and postoperative chemotherapy after interval debulking surgery (IDS) for advanced-stage epithelial ovarian cancer . PR/SD rate, percentage of optimal debulking surgery and 3-year disease-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 a high perioperative risk profile or a low likelihood of achieving cytoreduction to < 1 cm of residual disease (ideally to novisible disease) should receive neoadjuvant chemotherapy.
Hyperthermia promotes chemotherapy to penetrate deeper into the cancer tissue. Therefore, hyperthermic intraperitoneal chemotherapy (HIPEC) as neoadjuvant chemotherapy and postoperative chemotherapy after interval debulking 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
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Procedure: Hyperthermic Intraperitoneal Chemotherapy, Procedure: Interval debulking surgery, Drug: neoadjuvant chemotherapy, Drug: adjuvant chemotherapy1. Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with paclitaxel 175 mg/m^2 and cisplatin 75 mg/m^2 intraperitoneally in succession 2. 2 cycles of neoadjuvant chemotherapy: paclitaxel 175 mg/m^2 IV>3 hour+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks 3. Interval debulking surgery 4. Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with paclitaxel 175 mg/m^2 and cisplatin 75 mg/m^2 intraperitoneally in succession 5. 2 cycles of adjuvant chemotherapy: paclitaxel 175 mg/m^2 IV>3 hour+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks |
| Control group | Active comparator | Procedure: Interval debulking surgery, Drug: neoadjuvant chemotherapy, Drug: adjuvant chemotherapy1. 3 cycles of neoadjuvant chemotherapy: paclitaxel 175 mg/m^2 IV>3 hour+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks 2. Interval debulking surgery 3. 3 cycles of adjuvant chemotherapy: paclitaxel 175 mg/m^2 IV>3 hour+ 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 (10 listed)
- Disease status primary epithelial ovarian cancer, tubal cancer, and primary peritoneal cancer (Stage III and IV)
- Fagotti score by laparoscopic exploration >= 6
- After receiving HIPEC+neoadjuvant chemotherapy (NACT) or NACT alone, the curative effects evaluated according to RICIST criteria is partial remission (PR) and stable disease (SD).
- Residual tumor < 1cm after completion of interval debulking surgery
- 18 < Age < 70 year old
Key exclusion criteria (9 listed)
- Fagotti score by laparoscopic exploration < 6
- After receiving HIPEC+neoadjuvant chemotherapy (NACT) or NACT alone, the progression of disease (PD) is evaluated by doctor.
- Suboptimal debulking (residual tumor > 1cm)
- Extensive adhesion in peritoneal cavity
- Previous History of other malignancies (except excision of skin cancer, thyroid cancer)
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 neoadjuvant chemotherapy(NACT) and postoperative chemotherapy after interval debulking surgery (IDS) for advanced-stage epithelial ovarian cancer. The first HIPEC is conducted within 24h after laparoscopic exploration or Interval debulking surgery: Paclitaxel 175 mg/m^2, 43°C, 90min. The second HIPEC is performed after 48 hours of the first HIPEC. The second HIPEC regimens are cisplatin 75 mg/m^2, 43°C, 90min. | Procedure or surgery | Experimental group |
| Interval debulking surgeryAlso: IDSCytoreductive surgery (CRS) is performed after neoadjuvant chemotherapy. | Procedure or surgery | Control group, Experimental group |
| neoadjuvant chemotherapyAlso: NACTSystemic 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 laparoscopic exploration 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 |
| 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
PR/SD rate
Time frame: Through study completion, an average of 1 year
calculate the percent of partial remission (PR) plus stable disease (SD) of patients received HIPEC+NACT or NACT alone in both two arms
Percentage of optimal debulking surgery
Time frame: Through study completion, an average of 1 year
evaluate the percentage of optimal debulk (residual disease < 1cm) after interval debulking surgery between study arms
Disease-free survival rate
Time frame: 3 years
assess disease free survival rate during 3 years in both study arms
4 secondary outcomes
Overall survival rate
Time frame: 3 years
Risk factors for morbidity and mortality
Time frame: Through study completion, an average of 1 year
Quality of life
Time frame: 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 24 Jan 2018.
- Individual participant dataSharing planned: No
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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
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 Hyperthermic Intraperitoneal Chemotherapy, Interval debulking surgery and neoadjuvant chemotherapy in people with Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by Shu-Zhong Cui 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 9 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 24 Jan 2018. 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 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?
PR/SD rate (time frame: Through study completion, an average of 1 year). 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?
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 24 Jan 2018.