Malignant Neoplasm of StomachPhase 2NCT02528110
Radical Gastrectomy and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Locally Advanced Gastric Cancer
A Phase 2 study testing Hyperthermic intraperitoneal chemotherapy (HIPEC), D2 radical gastrectomy and SOX postoperative chemotherapy in people with Malignant Neoplasm of Stomach, run by Wuhan University at 1 site in China.
Trial summary
The efficacy of HIPEC in prevention of local recurrence, distant metastasis or peritoneal metastasis in locally advanced gastric cancer is not definite. The hypothesis of the trial is that radical gastrectomy plus HIPEC is superior to only radical gastrectomy in terms of overall survival. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Malignant Neoplasm of Stomach
- What is being tested?
- Hyperthermic intraperitoneal chemotherapy (HIPEC), D2 radical gastrectomy and SOX postoperative chemotherapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Aug 2015to 10 Mar 2020
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological proved diagnosis of locally advanced gastric cancer.
- No evidence of distant metastases or peritoneal metastases.
- Preoperative examination (CT/MRI) demonstrated resectable gastric cancer with T3-T4 stage.
- Eligible for radical gastrectomy with D2 lymphadenectomy.
- Have not received cytotoxic chemotherapy or radiotherapy.
- Written informed consent is obtained prior to commencement of trial treatment.
Who cannot join
- Existence of distant metastasis or peritoneal metastasis during surgery (M1).
- Any previous chemotherapy or radiotherapy
- Active systemic infections
- Inadequate cardiac function, renal function, liver function or bone marrow function at the beginning of the trial.
- Female patients who are pregnant or breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in the Treatment of Locally Advanced Gastric Cancer During Radical Gastrectomy
The efficacy of HIPEC in prevention of local recurrence, distant metastasis or peritoneal metastasis in locally advanced gastric cancer is not definite. The hypothesis of the trial is that radical gastrectomy plus HIPEC is superior to only radical gastrectomy in terms of overall survival.
Read the detailed description
To determine the efficacy of HIPEC in the treatment of locally advanced gastric cancer, patients are randomized into HIPEC group and control group. In HIPEC group, the patients undergo radical gastrectomy with D2 lymphadenectomy and HIPEC with paclitaxel and 5-Fu. Patients in the control group just undergo radical gastrectomy with D2 lymphadenectomy. Patients in both groups receive 6 cycles of postoperative chemotherapy (SOX or XELOX) and are followed up for 5 years or until death.
The trial is designed as a prospective, randomized, open, multicenter and parallel group study.
- Conditions
- Malignant Neoplasm of Stomach
- Being tested
- Hyperthermic intraperitoneal chemotherapy (HIPEC), D2 radical gastrectomy, SOX postoperative chemotherapy, XELOX postoperative chemotherapy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperthermic intraperitoneal chemotherapy (HIPEC)Procedure or surgery
Normal saline 3000ml-4000ml, Paclitaxel 75mg/m2, 5-Fu 15mg/m2, 43°C, 60min.
D2 radical gastrectomyProcedure or surgery
radical gastrectomy with D2 lymphadenectomy
SOX postoperative chemotherapyOther
Oxaliplatin 130mg/m2 d1, Tegafur,Gimeracil and Oteracil Porassium Capsules 60mg, d1-14.
XELOX postoperative chemotherapyOther
Oxaliplatin 130mg/m2 d1, Capecitabine 1000mg/m2 d1-14.
| Study group | Role | What they receive |
|---|---|---|
| Radical gastrectomy without HIPEC | Sham comparator | Patients will be treated with a D2 radical gastrectomy for locally advanced gastric cancer and postoperative chemotherapy (SOX or XELOX) Receives: Procedure: D2 radical gastrectomy; Other: SOX postoperative chemotherapy; Other: XELOX postoperative chemotherapy |
| Radical gastrectomy with HIPEC | Experimental | Patients will be treated with a D2 radical gastrectomy for locally advanced gastric cancer and HIPEC with paclitaxel and 5-Fu and postoperative chemotherapy (SOX or XELOX) Receives: Procedure: Hyperthermic intraperitoneal chemotherapy (HIPEC); Procedure: D2 radical gastrectomy; Other: SOX postoperative chemotherapy; Other: XELOX postoperative 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 (5)
progression-free survival
Measured: 5 years
distant metastasis rate
Measured: 5 years
peritoneal metastasis rate
Measured: 5 years
local recurrence rate
Measured: 5 years
complication rate
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 posted19 Aug 2015 (estimated)
- Study startAug 2015
- Primary completion10 Mar 2020
- Study completion10 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Neoplasm of StomachStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuhan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bin Xiong, MD, Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02528110
- Sponsor's protocol ID
- WuhanU_HIPEC
- Status last verified
- Mar 2020
- First submitted
- 16 Aug 2015
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in the Treatment of Locally Advanced Gastric Cancer During Radical Gastrectomy
- ClinicalTrials.gov ID
- NCT02528110
- Acronym / sponsor ID
- WuhanU_HIPEC
- Conditions
- Malignant Neoplasm of Stomach
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Wuhan UniversityUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- 10 Mar 2020 (actual)
- Study completion
- 10 Mar 2020 (actual)
- First posted
- 19 Aug 2015 (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 efficacy of HIPEC in prevention of local recurrence, distant metastasis or peritoneal metastasis in locally advanced gastric cancer is not definite. The hypothesis of the trial is that radical gastrectomy plus HIPEC is superior to only radical gastrectomy in terms of overall survival.
Detailed description
To determine the efficacy of HIPEC in the treatment of locally advanced gastric cancer, patients are randomized into HIPEC group and control group. In HIPEC group, the patients undergo radical gastrectomy with D2 lymphadenectomy and HIPEC with paclitaxel and 5-Fu. Patients in the control group just undergo radical gastrectomy with D2 lymphadenectomy. Patients in both groups receive 6 cycles of postoperative chemotherapy (SOX or XELOX) and are followed up for 5 years or until death.
The trial is designed as a prospective, randomized, open, multicenter and parallel group study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radical gastrectomy without HIPEC | Sham comparator | Procedure: D2 radical gastrectomy, Other: SOX postoperative chemotherapy, Other: XELOX postoperative chemotherapyPatients will be treated with a D2 radical gastrectomy for locally advanced gastric cancer and postoperative chemotherapy (SOX or XELOX) |
| Radical gastrectomy with HIPEC | Experimental | Procedure: Hyperthermic intraperitoneal chemotherapy (HIPEC), Procedure: D2 radical gastrectomy, Other: SOX postoperative chemotherapy, Other: XELOX postoperative chemotherapyPatients will be treated with a D2 radical gastrectomy for locally advanced gastric cancer and HIPEC with paclitaxel and 5-Fu and postoperative chemotherapy (SOX or XELOX) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histological proved diagnosis of locally advanced gastric cancer.
- No evidence of distant metastases or peritoneal metastases.
- Preoperative examination (CT/MRI) demonstrated resectable gastric cancer with T3-T4 stage.
- Eligible for radical gastrectomy with D2 lymphadenectomy.
- Have not received cytotoxic chemotherapy or radiotherapy.
Key exclusion criteria (5 listed)
- Existence of distant metastasis or peritoneal metastasis during surgery (M1).
- Any previous chemotherapy or radiotherapy
- Active systemic infections
- Inadequate cardiac function, renal function, liver function or bone marrow function at the beginning of the trial.
- Female patients who are pregnant or breast feeding
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 chemotherapy (HIPEC)Normal saline 3000ml-4000ml, Paclitaxel 75mg/m2, 5-Fu 15mg/m2, 43°C, 60min. | Procedure or surgery | Radical gastrectomy with HIPEC |
| D2 radical gastrectomyradical gastrectomy with D2 lymphadenectomy | Procedure or surgery | Radical gastrectomy with HIPEC, Radical gastrectomy without HIPEC |
| SOX postoperative chemotherapyOxaliplatin 130mg/m2 d1, Tegafur,Gimeracil and Oteracil Porassium Capsules 60mg, d1-14. | Other | Radical gastrectomy with HIPEC, Radical gastrectomy without HIPEC |
| XELOX postoperative chemotherapyOxaliplatin 130mg/m2 d1, Capecitabine 1000mg/m2 d1-14. | Other | Radical gastrectomy with HIPEC, Radical gastrectomy without HIPEC |
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
5 secondary outcomes
progression-free survival
Time frame: 5 years
distant metastasis rate
Time frame: 5 years
peritoneal metastasis rate
Time frame: 5 years
local recurrence rate
Time frame: 5 years
complication rate
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hyperthermic intraperitoneal chemotherapy (HIPEC), D2 radical gastrectomy and SOX postoperative chemotherapy in people with Malignant Neoplasm of Stomach, run by Wuhan 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 24 Mar 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 24 Mar 2020.