Malignant Neoplasm of StomachPhase 3NCT02381847
Radical Gastrectomy With/Without HIPEC in Advanced Gastric Cancer Patients
A Phase 3 study testing intraperitoneal chemoperfusion in people with Malignant Neoplasm of Stomach, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
Patients with histological proven advanced gastric cancer (including cancer of the esophagogastric junction (AEG) without evidence of distant metastases, who fulfill the inclusion and exclusion criteria, can be recruited in this study. There are two treatment groups (A and B). 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?
- intraperitoneal chemoperfusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Mar 2020
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological proved diagnosis of peritoneal metastasized gastric cancer including carcinoma of the AEG.
- No evidence of distant metastases
- preoperative examination (CT/MRI) demonstrated resectable gastricc cancer with T3-T4 stage
- Written informed consent is obtained prior to commencement of trial treatment
Who cannot join
- Any previous chemotherapy or radiotherapy, and any investigational treatment for gastric cancer
- Active systemic infections
- Patients with known interstitial lung disease with New York Heart Association classification > 2
- Serious cardiac dysrhythmia or condition, New York Heart Association classification of III or IV, congestive cardiac failure
- cardiac arrhythmia
- Inadequate renal function at the beginning of the trial, defined as GFR less than <60 ml/min
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- Inadequate liver function at the beginning of the trial, defined as Bilirubin >1.5 times ULN
- Inadequate bone marrow function at the beginning of the trial, defined as platelet count less than <150 GPT/L or neutrophil granulocyte count less than <1.5 GPT/
- Active vaccination within 6 weeks prior to randomisation
- Active hepatitis B or C infection
- Female patients who are pregnant or breast feeding
- Missing of capacity to contract
- contraindication to the drugs which are used in the trial
- Participation in another therapeutic clinical trial
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Meng Wang
Nanjing, Jiangsu, 210000
Meng Wang, 86-13815890469, wangmeng001@263.net
Wenxian Guan, 86-25-83106666, guan_wx@163.com
About this study
Official title: Prospective Phase III Trial Using Radical Gastrectomy With/Without HIPEC in Advanced Gastric Cancer Patients Including Adenocarcinoma of the Esophagogastric Junction
Patients with histological proven advanced gastric cancer (including cancer of the esophagogastric junction (AEG) without evidence of distant metastases, who fulfill the inclusion and exclusion criteria, can be recruited in this study. There are two treatment groups (A and B). The D2 radical gastrectomy will be applied in both groups. Patients randomized into group B will be treated with an intraperitoneal (in the abdominal cavity) chemoperfusion with cisplatin(75mg/m2 max 150mg/m2 max 5L ). Patients randomized into group A will not accept intraperitoneal chemoperfusion. Patients in both groups receive 6 cycles of postoperative chemotherapy (SOX or XELOX) within 4-12 weeks after the surgical procedure and are followed up for 24 months.
Read the detailed description
The objective of the trial is to compare the treatment of patients with advanced gastric cancer without evidence of distant metastases treated with D2 radical gastrectomy and intraperitoneal chemoperfusion (HIPEC) and postoperative chemotherapy (Group B) and patients treated with D2 radical gastrectomy alone and postoperative chemotherapy (Group A).
The hypothesis of the trial is that D2 radical gastrectomy with intraperitoneal chemoperfusion (Group B) is superior to D2 radical gastrectomy (Group A) in terms of overall survival.
The trial is designed as a prospective, randomized, open, multicenter and parallel group study.
- Conditions
- Malignant Neoplasm of Stomach
- Being tested
- intraperitoneal chemoperfusion
- Keywords
- gastric cancer, intraperitoneal chemoperfusion
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraperitoneal chemoperfusionProcedure or surgery
Also called HIPEC
HIPEC with cisplatin at the time of D2 radical surgery
| Study group | Role | What they receive |
|---|---|---|
| without HIPEC | No intervention | Patients will be treated with a D2 radical gastrectomy for advanced gastric cancer and postoperative chemotherapy (SOX or XELOX). |
| with HIPEC | Experimental | Patients will be treated with a D2 radical gastrectomy for advanced gastric cancer and intraperitoneal chemoperfusion with cisplatin and postoperative chemotherapy as described for the control group.
Cisplatin: 75mg/m2 (max 150mg/m2 max 5L ) Receives: Procedure: intraperitoneal chemoperfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
overall survival [ Time Frame: Death or 2 years ]
Measured: 24 months
Secondary outcomes (3)
complication rate
Measured: 30 days
time to progress
follow up every 3 months till 24 months end of study
Measured: 24 months
time to distant metastasis
time to other distant metastases follow up every 3 months till 24 months
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startJan 2015
- Primary completionMar 2017 (estimated)
- Study completionMar 2020 (estimated)
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.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenxian Guan, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Investigators
- Wenxian Guan, Principal investigator, China Health Ministry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02381847
- Sponsor's protocol ID
- NDTHNanjingUMS
- Status last verified
- Feb 2015
- First submitted
- 28 Feb 2015
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Phase III Trial Using Radical Gastrectomy With/Without HIPEC in Advanced Gastric Cancer Patients Including Adenocarcinoma of the Esophagogastric Junction
- ClinicalTrials.gov ID
- NCT02381847
- Acronym / sponsor ID
- NDTHNanjingUMS
- Conditions
- Malignant Neoplasm of Stomach
- Keywords
- gastric cancer, intraperitoneal chemoperfusion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 6 Mar 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.
Patients with histological proven advanced gastric cancer (including cancer of the esophagogastric junction (AEG) without evidence of distant metastases, who fulfill the inclusion and exclusion criteria, can be recruited in this study. There are two treatment groups (A and B). The D2 radical gastrectomy will be applied in both groups. Patients randomized into group B will be treated with an intraperitoneal (in the abdominal cavity) chemoperfusion with cisplatin(75mg/m2 max 150mg/m2 max 5L ). Patients randomized into group A will not accept intraperitoneal chemoperfusion. Patients in both groups receive 6 cycles of postoperative chemotherapy (SOX or XELOX) within 4-12 weeks after the surgical procedure and are followed up for 24 months.
Detailed description
The objective of the trial is to compare the treatment of patients with advanced gastric cancer without evidence of distant metastases treated with D2 radical gastrectomy and intraperitoneal chemoperfusion (HIPEC) and postoperative chemotherapy (Group B) and patients treated with D2 radical gastrectomy alone and postoperative chemotherapy (Group A).
The hypothesis of the trial is that D2 radical gastrectomy with intraperitoneal chemoperfusion (Group B) is superior to D2 radical gastrectomy (Group A) in terms of overall survival.
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
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| without HIPEC | No intervention | –Patients will be treated with a D2 radical gastrectomy for advanced gastric cancer and postoperative chemotherapy (SOX or XELOX). |
| with HIPEC | Experimental | Procedure: intraperitoneal chemoperfusionPatients will be treated with a D2 radical gastrectomy for advanced gastric cancer and intraperitoneal chemoperfusion with cisplatin and postoperative chemotherapy as described for the control group. Cisplatin: 75mg/m2 (max 150mg/m2 max 5L ) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histological proved diagnosis of peritoneal metastasized gastric cancer including carcinoma of the AEG.
- No evidence of distant metastases
- preoperative examination (CT/MRI) demonstrated resectable gastricc cancer with T3-T4 stage
- Written informed consent is obtained prior to commencement of trial treatment
Key exclusion criteria (14 listed)
- Any previous chemotherapy or radiotherapy, and any investigational treatment for gastric cancer
- Active systemic infections
- Patients with known interstitial lung disease with New York Heart Association classification > 2
- Serious cardiac dysrhythmia or condition, New York Heart Association classification of III or IV, congestive cardiac failure
- cardiac arrhythmia
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 |
|---|---|---|
| intraperitoneal chemoperfusionAlso: HIPECHIPEC with cisplatin at the time of D2 radical surgery | Procedure or surgery | with HIPEC |
Primary outcome
overall survival
Time frame: 24 months
overall survival [ Time Frame: Death or 2 years ]
3 secondary outcomes
complication rate
Time frame: 30 days
time to progress
Time frame: 24 months
time to distant metastasis
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
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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.
Wenxian Guan principal investigator
China Health Ministry
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 intraperitoneal chemoperfusion in people with Malignant Neoplasm of Stomach, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 4 inclusion and 14 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 Mar 2015. 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 Meng Wang (86-13815890469, wangmeng001@263.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: 24 months). 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 Mar 2015.