Advanced Gastric AdenocarcinomaPhase 3HIPECNCT02240524
Efficacy of HIPEC in the Treatment of Patients With Locally Advanced Gastric Cancer
A Phase 3 study testing D2 lymphadenectomy, Systemic chemotherapy and HIPEC in people with Advanced Gastric Adenocarcinoma, run by Affiliated Cancer Hospital & Institute of Guangzhou Medical University at 1 site in China.
Trial summary
The purpose of this study is to study the efficacy of hyperthermic intraperitoneal chemotherapy in the treatment of patients with locally advanced gastric cancer after radical gastrectomy with D2 lymphadenectomy. It is a multicentric and randomised phase III trial. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Advanced Gastric Adenocarcinoma
- What is being tested?
- D2 lymphadenectomy, Systemic chemotherapy and HIPEC
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 582 participants
- Where
- 1 siteChina
- Study dates
- Jul 2014to Jul 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 < age ≤ 65 years old
- Male or Non pregnant female
- The Eastern Cooperative Oncology Group (ECOG) status ≤ 2
- Histologically diagnosed as T4 gastric adenocarcinoma (determined from data obtained by endoscopic ultrasound or CT scan)
- Have not received cytotoxic chemotherapy, radiotherapy or immunotherapy
- White blood cells > 4,000/mm3
Show all 13Show fewer
- neutrophils ≥ 1,500/mm3
- platelets ≥ 100,000/mm3
- hemoglobin>9g/l
- Alanine transaminase (ALT) and aspartate aminotransferase (AST) < or = 2.5 times upper limit of nominal (ULN)
- total bilirubin (TBIL) < 1.5 times ULN
- serum creatinine < 1 times ULN
- Having given written informed consent prior to any procedure related to the study
Who cannot join
- Existence of macroscopic peritoneal implants
- Prior malignant tumors with detectable signs of recurrence or distant metastasis
- Poorly controlled disease e.g. atrial fibrillation, stenocardia, cardiac insufficiency, persistent hypertension despite medicinal treatment, ejection fraction<50%
- Receiving other cytotoxic chemotherapy
- High grade of intra-abdominal adhesions
- Contraindication to any therapy contained in this regimen specific to the study Without given written informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Abdominal Surgery (Section 2), Affiliated Tumor Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510095
zhiyuan fang, Ph.D, 86020666736662012, fangjnu@gmail.com
shuzhong cui, Ph.D
About this study
Official title: A Phase III Study of Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Locally Advanced Gastric Cancer After radIcal Gastrectomy With D2 Lymphadenectomy
The purpose of this study is to study the efficacy of hyperthermic intraperitoneal chemotherapy in the treatment of patients with locally advanced gastric cancer after radical gastrectomy with D2 lymphadenectomy. It is a multicentric and randomised phase III trial.
- Conditions
- Advanced Gastric Adenocarcinoma
- Being tested
- D2 lymphadenectomy, Systemic chemotherapy, HIPEC
- Keywords
- Gastric adenocarcinoma, HIPEC, Paclitaxel, Oxaliplatin, Capecitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D2 lymphadenectomyProcedure or surgery
The dissected lymph nodes were classified according to the Japanese Classification of Gastric Carcinoma, first English edition.
Systemic chemotherapyProcedure or surgery
HIPECProcedure or surgery
Also called hyperthermic intraperitoneal chemoperfusion
| Study group | Role | What they receive |
|---|---|---|
| D2 lymphadenectomy and HIPEC and Systemic chemotherapy | Experimental | Intraoperative and postoperative hyperthermic intraperitoneal chemotherapy (twice HIPEC) were performed after radical gastrectomy with D2 lymphadenectomy, followed by 8 cycles of systemic chemotherapy.
HIPEC was conducted within 48 h after surgery: Normal saline 3000ml-4000ml, Paclitaxel 75mg/m^2, 43°C, 60min.
Systemic chemotherapy (XELOX):
Oxaliplatin: 130mg/m^2, d1, Intravenous infusion, every 3 weeks. Capecitabine: 1g/m^2 bid, days 1-14, every 3 weeks and maximum 8 cycles, or progression/intolerance. Receives: Procedure: D2 lymphadenectomy; Procedure: Systemic chemotherapy; Procedure: HIPEC |
| D2 lymphadenectomy+Systemic chemotherapy | Placebo comparator | 8 cycles of systemic chemotherapy were performed after radical gastrectomy with D2 lymphadenectomy.
Systemic chemotherapy (XELOX):
Oxaliplatin: 130mg/m^2, d1, Intravenous infusion, every 3 weeks. Capecitabine: 1g/m^2 bid, days 1-14, every 3 weeks and maximum 8 cycles, or progression/intolerance. Receives: Procedure: D2 lymphadenectomy; Procedure: Systemic chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
From the date of surgery to the date of death or to the end of follow-up
Measured: 5 years
Secondary outcomes (3)
Recurrence-free survival
From the date of surgery to the date of recurrence or to the end of follow-up
Measured: 5 years
Locoregional-free survival
From the date of surgery to the date of locoregional recurrence or to the end of follow-up
Measured: 5 years
Hepatic metastases-free survival
From the date of surgery to the date of recurrence or to the end of follow-up
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Gastric AdenocarcinomaStudies 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
- 582 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Cancer Hospital & Institute of Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- shuzhong cui, Ph.D, Study director, Affiliated Cancer Hospital & Institute of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02240524
- Sponsor's protocol ID
- 2014514
- Acronym
- HIPEC
- Status last verified
- Sep 2014
- First submitted
- 3 Jun 2014
- Last updated
- 15 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Study of Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Locally Advanced Gastric Cancer After radIcal Gastrectomy With D2 Lymphadenectomy
- ClinicalTrials.gov ID
- NCT02240524
- Acronym / sponsor ID
- HIPEC / 2014514
- Conditions
- Advanced Gastric Adenocarcinoma
- Keywords
- Gastric adenocarcinoma, HIPEC, Paclitaxel, Oxaliplatin, Capecitabine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 582 participants (estimated)
- Lead sponsor
- Affiliated Cancer Hospital & Institute of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 15 Sep 2014 (estimated)
- 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.
The purpose of this study is to study the efficacy of hyperthermic intraperitoneal chemotherapy in the treatment of patients with locally advanced gastric cancer after radical gastrectomy with D2 lymphadenectomy. It is a multicentric and randomised phase III trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D2 lymphadenectomy and HIPEC and Systemic chemotherapy | Experimental | Procedure: D2 lymphadenectomy, Procedure: Systemic chemotherapy, Procedure: HIPECIntraoperative and postoperative hyperthermic intraperitoneal chemotherapy (twice HIPEC) were performed after radical gastrectomy with D2 lymphadenectomy, followed by 8 cycles of systemic chemotherapy. HIPEC was conducted within 48 h after surgery: Normal saline 3000ml-4000ml, Paclitaxel 75mg/m^2, 43°C, 60min. Systemic chemotherapy (XELOX): Oxaliplatin: 130mg/m^2, d1, Intravenous infusion, every 3 weeks. Capecitabine: 1g/m^2 bid, days 1-14, every 3 weeks and maximum 8 cycles, or progression/intolerance. |
| D2 lymphadenectomy+Systemic chemotherapy | Placebo comparator | Procedure: D2 lymphadenectomy, Procedure: Systemic chemotherapy8 cycles of systemic chemotherapy were performed after radical gastrectomy with D2 lymphadenectomy. Systemic chemotherapy (XELOX): Oxaliplatin: 130mg/m^2, d1, Intravenous infusion, every 3 weeks. Capecitabine: 1g/m^2 bid, days 1-14, every 3 weeks and maximum 8 cycles, or progression/intolerance. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 18 < age ≤ 65 years old
- Male or Non pregnant female
- The Eastern Cooperative Oncology Group (ECOG) status ≤ 2
- Histologically diagnosed as T4 gastric adenocarcinoma (determined from data obtained by endoscopic ultrasound or CT scan)
- Have not received cytotoxic chemotherapy, radiotherapy or immunotherapy
Key exclusion criteria (6 listed)
- Existence of macroscopic peritoneal implants
- Prior malignant tumors with detectable signs of recurrence or distant metastasis
- Poorly controlled disease e.g. atrial fibrillation, stenocardia, cardiac insufficiency, persistent hypertension despite medicinal treatment, ejection fraction<50%
- Receiving other cytotoxic chemotherapy
- High grade of intra-abdominal adhesions
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 |
|---|---|---|
| D2 lymphadenectomyThe dissected lymph nodes were classified according to the Japanese Classification of Gastric Carcinoma, first English edition. | Procedure or surgery | D2 lymphadenectomy and HIPEC and Systemic chemotherapy, D2 lymphadenectomy+Systemic chemotherapy |
| Systemic chemotherapy | Procedure or surgery | D2 lymphadenectomy and HIPEC and Systemic chemotherapy, D2 lymphadenectomy+Systemic chemotherapy |
| HIPECAlso: hyperthermic intraperitoneal chemoperfusion | Procedure or surgery | D2 lymphadenectomy and HIPEC and Systemic chemotherapy |
Primary outcome
Overall survival
Time frame: 5 years
From the date of surgery to the date of death or to the end of follow-up
3 secondary outcomes
Recurrence-free survival
Time frame: 5 years
Locoregional-free survival
Time frame: 5 years
Hepatic metastases-free survival
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2014.
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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, Ph.D study director
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 D2 lymphadenectomy, Systemic chemotherapy and HIPEC in people with Advanced Gastric Adenocarcinoma, run by Affiliated Cancer Hospital & Institute of Guangzhou Medical University 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 13 inclusion and 6 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 15 Sep 2014. 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. Some participants in this study may receive a placebo. 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 zhiyuan fang, Ph.D (86020666736662012, fangjnu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 5 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 15 Sep 2014.