Gastric CancerPhase 3NCT03179579
Efficacy of HIPEC Combined With Systemic Chemotherapy and CRS on Peritoneal Metastases From Gastric Cancer
A Phase 3 study testing HIPEC with neoadjuvant chemotherapy and Systemic chemotherapy in people with Gastric Cancer and Peritoneal Carcinomatosis, 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 that stage IV limited peritoneal metastasis of gastric cancer patients accept hyperthermic intraperitoneal chemotherapy plus neoadjuvant chemotherapy with CRS and systemic chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastric Cancer, Peritoneal Carcinomatosis
- What is being tested?
- HIPEC with neoadjuvant chemotherapy and Systemic chemotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2017to 1 Aug 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gastic adenocarcinoma is diagnosed by histological and cytological examination.
- Peritoneal carcinomastosis of gastric cancer is diagnosed by laparotomy or laparoscopic exploration.
- According to Sugarbaker's peritoneal cancer index (PCI), PCI score of participant is no more than 20.
- 18 < Age < 70 year old
- Expected survival > 3 months
- Performance status: ECOG 0-1
Show all 9Show fewer
- Adequate bone marrow function Hb ≥9 g/dl (After correction in case of iron deficient anemia) WBC ≥ 3,500/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 ≤ 2.5×ULN
- 10. Voluntary participation after getting written informed consent.
Who cannot join
- Except for peritoneal carcinomatosis, gastric cancer concurrently metastasized to liver, lung, para-aortic lymph node and other distant organs.
- Extensive adhesion in peritoneal cavity
- Previous History of other malignancies
- 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
1 site in 1 country.
China1 site
Department of Abdominal Surgery (Section 2), Affiliated Tumor Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510095
Xianzi Yang, M.D, 8602066673666, 7097359@qq.com
shuzhong cui, M.D
About this study
Official title: A Phase III Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Combined With Systemic Chemotherapy And Cytoreductive Surgery (CRS) in the Treatment of Peritoneal Carcinomatosis From Gastric Cancer
This project is a multi-center, prospective, randomized controlled clinical observation the safety and efficacy that stage IV limited peritoneal metastasis of gastric cancer patients accept hyperthermic intraperitoneal chemotherapy plus neoadjuvant chemotherapy with CRS and systemic chemotherapy. With advanced-stage gastric patients of confined to the peritoneal as the research object, with median progression-free survival and overall survival, adverse events as the end points.
Read the detailed description
Peritoneal metastases in gastric cancer are considered as terminal disease with poor prognosis, the median survival time of this kind of patients is less than 1 year and even worse in China. Recently, cytoreductive surgery (CRS) combined with hyperthermic intraperitoneal chemotherapy (HIPEC) has been suggested to improve survival in patients with peritoneal metastases from gastric cancer. Even though the REGATTA trial demonstrated that the removal of the primary tumor is not necessarily beneficial, the role of operation aiming at R0 resection combined with new regimens like HIPEC and new chemotherapeutic agents is still confusing. Neoadjuvant chemotherapy prolonged OS of patients received macroscopically radical (CC0) surgery. Compared to systemic chemotherapy, HIPEC promotes chemotherapy to penetrate deeper into the cancer tissue, which needed multicenter randomized clinical trials (RCTs) to comfirm. Therefore, we has conducting prospective phase III trial of HIPEC combined with systemic chemotherapy and CRS for gastric cancer with peritoneal metastasis.
- Conditions
- Gastric Cancer, Peritoneal Carcinomatosis
- Being tested
- HIPEC with neoadjuvant chemotherapy, Systemic chemotherapy
- Keywords
- Gastric Cancer, Peritoneal Carcinomatosis, Hyperthermic Intraperitoneal Chemotherapy, Systemic Chemotherapy, Cytoreductive Surgery
- Medical subject headings
- Stomach Neoplasms, Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIPEC with neoadjuvant chemotherapyProcedure or surgery
Also called CRS with HIPEC and adjuvant cheomtherapy
HIPEC 3 times +NACT 2 cycles +CRS +HIPEC 3 times+ ACT 4-6 cycles
Systemic chemotherapyProcedure or surgery
Also called CRS with systemic chemotherpay
NACT 3 cycles +CRS +ACT 4-6 cycles
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 1. HIPEC with paclitaxel 135 mg/m^2+HIPEC with cisplatin 75 mg/m^2±HIPEC with Raltitrexed 3 mg/m^2 intraperitoneally in succession
2. 2 cycles of neoadjuvant chemotherapy: S-1 40-60 mg/m^2, d1-d14, Bid p.o.+ oxaliplatin 130 mg/m^2, d1, IV, every 3 weeks
3. Cytoreductive surgery
4. HIPEC with paclitaxel 135 mg/m^2+HIPEC with cisplatin 75 mg/m^2±HIPEC with Raltitrexed 3 mg/m^2 intraperitoneally in succession
5. 4-6 cycles of adjuvant chemotherapy: S-1 40-60 mg/m^2, d1-d14, Bid p.o.+ oxaliplatin 130 mg/m^2, d1, IV, every 3 weeks Receives: Procedure: HIPEC with neoadjuvant chemotherapy |
| Control group | Active comparator | 1. 3 cycles of neoadjuvant chemotherapy: S-1 40-60 mg/m^2, d1-d14, Bid p.o.+ oxaliplatin 130 mg/m^2, d1, IV, every 3 weeks
2. Cytoreductive surgery
3. 4-6 cycles of adjuvant chemotherapy: S-1 40-60 mg/m^2, d1-d14, Bid p.o.+ oxaliplatin 130 mg/m^2, d1, IV, every 3 weeks Receives: Procedure: Systemic chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median overall survival
assess median overall survival rate during 3 years in both study arms
Measured: 3 years
Secondary outcomes (1)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start1 Aug 2017 (estimated)
- Primary completion1 Aug 2021 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric 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
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shu-Zhong Cui
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Medical University Cancer Institute and Hospital, Chinese PLA General Hospital, Harbin Medical University, Southern Medical University, China, Guangdong Provincial People's Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine
- Responsible party
- Sponsor-investigator, Shu-Zhong Cui, Affiliated Cancer Hospital & Institute of Guangzhou Medical University
- Investigators
- Shu-Zhong Cui, M.D, Study chair, Affiliated Cancer Hospital & Institute of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03179579
- Sponsor's protocol ID
- HIPEC-02
- Status last verified
- Jun 2017
- First submitted
- 6 Jun 2017
- Last updated
- 7 Jun 2017
- 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 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Combined With Systemic Chemotherapy And Cytoreductive Surgery (CRS) in the Treatment of Peritoneal Carcinomatosis From Gastric Cancer
- ClinicalTrials.gov ID
- NCT03179579
- Acronym / sponsor ID
- HIPEC-02
- Conditions
- Gastric Cancer, Peritoneal Carcinomatosis
- Keywords
- Gastric Cancer, Peritoneal Carcinomatosis, Hyperthermic Intraperitoneal Chemotherapy, Systemic Chemotherapy, Cytoreductive Surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Shu-Zhong CuiUniversity, hospital or other
- Collaborators
- Tianjin Medical University Cancer Institute and Hospital, Chinese PLA General Hospital, Harbin Medical University, Southern Medical University, China, Guangdong Provincial People's Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine
- Study start
- 1 Aug 2017 (estimated)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 7 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 that stage IV limited peritoneal metastasis of gastric cancer patients accept hyperthermic intraperitoneal chemotherapy plus neoadjuvant chemotherapy with CRS and systemic chemotherapy. With advanced-stage gastric patients of confined to the peritoneal as the research object, with median progression-free survival and overall survival, adverse events as the end points.
Detailed description
Peritoneal metastases in gastric cancer are considered as terminal disease with poor prognosis, the median survival time of this kind of patients is less than 1 year and even worse in China. Recently, cytoreductive surgery (CRS) combined with hyperthermic intraperitoneal chemotherapy (HIPEC) has been suggested to improve survival in patients with peritoneal metastases from gastric cancer. Even though the REGATTA trial demonstrated that the removal of the primary tumor is not necessarily beneficial, the role of operation aiming at R0 resection combined with new regimens like HIPEC and new chemotherapeutic agents is still confusing. Neoadjuvant chemotherapy prolonged OS of patients received macroscopically radical (CC0) surgery. Compared to systemic chemotherapy, HIPEC promotes chemotherapy to penetrate deeper into the cancer tissue, which needed multicenter randomized clinical trials (RCTs) to comfirm. Therefore, we has conducting prospective phase III trial of HIPEC combined with systemic chemotherapy and CRS for gastric cancer with peritoneal metastasis.
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: HIPEC with neoadjuvant chemotherapy1. HIPEC with paclitaxel 135 mg/m^2+HIPEC with cisplatin 75 mg/m^2±HIPEC with Raltitrexed 3 mg/m^2 intraperitoneally in succession 2. 2 cycles of neoadjuvant chemotherapy: S-1 40-60 mg/m^2, d1-d14, Bid p.o.+ oxaliplatin 130 mg/m^2, d1, IV, every 3 weeks 3. Cytoreductive surgery 4. HIPEC with paclitaxel 135 mg/m^2+HIPEC with cisplatin 75 mg/m^2±HIPEC with Raltitrexed 3 mg/m^2 intraperitoneally in succession 5. 4-6 cycles of adjuvant chemotherapy: S-1 40-60 mg/m^2, d1-d14, Bid p.o.+ oxaliplatin 130 mg/m^2, d1, IV, every 3 weeks |
| Control group | Active comparator | Procedure: Systemic chemotherapy1. 3 cycles of neoadjuvant chemotherapy: S-1 40-60 mg/m^2, d1-d14, Bid p.o.+ oxaliplatin 130 mg/m^2, d1, IV, every 3 weeks 2. Cytoreductive surgery 3. 4-6 cycles of adjuvant chemotherapy: S-1 40-60 mg/m^2, d1-d14, Bid p.o.+ oxaliplatin 130 mg/m^2, d1, IV, every 3 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Gastic adenocarcinoma is diagnosed by histological and cytological examination.
- Peritoneal carcinomastosis of gastric cancer is diagnosed by laparotomy or laparoscopic exploration.
- According to Sugarbaker's peritoneal cancer index (PCI), PCI score of participant is no more than 20.
- 18 < Age < 70 year old
- Expected survival > 3 months
Key exclusion criteria (7 listed)
- Except for peritoneal carcinomatosis, gastric cancer concurrently metastasized to liver, lung, para-aortic lymph node and other distant organs.
- Extensive adhesion in peritoneal cavity
- Previous History of other malignancies
- Poorly controlled disease e.g. atrial fibrillation, stenocardia, cardiac insufficiency, persistent hypertension despite medicinal treatment, ejection fraction<50%
- Receiving other chemotherapy, radiotherapy or immunotherapy
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 |
|---|---|---|
| HIPEC with neoadjuvant chemotherapyAlso: CRS with HIPEC and adjuvant cheomtherapyHIPEC 3 times +NACT 2 cycles +CRS +HIPEC 3 times+ ACT 4-6 cycles | Procedure or surgery | Experimental group |
| Systemic chemotherapyAlso: CRS with systemic chemotherpayNACT 3 cycles +CRS +ACT 4-6 cycles | Procedure or surgery | Control group |
Primary outcome
Median overall survival
Time frame: 3 years
assess median overall survival rate during 3 years in both study arms
1 secondary outcome
Risk factors for morbidity and mortality
Time frame: Through study completion, an average of 1 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2017.
- 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.
Shu-Zhong Cui, M.D study chair
Affiliated Cancer Hospital & Institute of Guangzhou Medical 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 HIPEC with neoadjuvant chemotherapy and Systemic chemotherapy in people with Gastric Cancer and Peritoneal Carcinomatosis, 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 9 inclusion and 7 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 7 Jun 2017. 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 Xian-Zi Yang, M.D (8602066673666, 7097359@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median overall 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 7 Jun 2017.