Gastric CancerNCT02172690
Laparoscopic Staging for Locally Advanced Gastric Cancer in Chinese Patients
A study testing Laparoscopic Staging in people with Gastric Cancer and Peritoneal Metastases, run by Peking University at 1 site in China.
Trial summary
RATIONALE: Laparoscopic staging may help doctors plan more effective treatment for gastric cancer, yet the efficiency have not been fully investigated in Chinese people. PURPOSE: Study the effectiveness of laparoscopic staging in patients with pre-diagnosed as locally advanced gastric cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Peritoneal Metastases
- What is being tested?
- Laparoscopic Staging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 452 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2014to 30 Sep 2017
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- sign written informed consent form
- age ≥ 18 years
- pathologically confirmed gastric or GEJ adenocarcinoma
- disease at clinical stage of locally advanced gastric cancer by CT/EUS(cT2+NanyM0)
- No prior antitumor treatment is allowed, including chemotherapy, radiotherapy, immune therapy or target therapy
- Adequate organ function as defined below:
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- Hematologic ANC ≥ 1.5109/l Hemoglobin ≥ 9 g/dl Platelets ≥ 100109/l Hepatic Albumin ≥ 30g/l Serum bilirubin ≤ 1.5×ULN AST and ALT ≤ 2.5×ULN ALP ≤ 2.5×ULN TBIL ≤ 1.5×ULN Renal Serum Creatinine < 1.5 ULN
- KPS ≥ 70
- Adequate lung and heart function
- Negative serum or urine pregnant test within 7 days prior to randomization for child-bearing age women
- Sexually active males or females willing to practice contraception during the study until 30 days after end of study.
Who cannot join
- Refuse to provide blood/tissue sample；
- With distant metastasis diagnosed by CT/EUS；
- Sexually active males or females refuse to practice contraception during the study until 30 days after end of study.
- History of organ transplantation（including autologous bone marrow transplantation and Peripheral stem cell transplantation）；
- Prior long term steroid therapy (excluding short term steroid treatment which is completed prior to > 2 weeks of study enrollment)；
- Patients with central nervous system(CNS) disorder or peripheral nervous system disorder or psychiatric disease；
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- Concurrent severe infection；
- Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety (including current active hepatic, biliary, renal, respiratory disease, uncontrolled diabetes hypertension et al)；
- History of other malignancy. However, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma, are eligible；
- Known history of uncontrolled or symptomatic angina, uncontrolled arrhythmias and hypertension, or congestive heart failure, or cardiac infarction within 6 months prior to study enrollment, or cardiac insufficiency；
- Person with no capacity (legally) or inappropriate to continue study treatment for ethics/medical reasons.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Unicersity Cancer Hospital
Beijing, Beijing Municipality, 100142
About this study
Official title: Laparoscopic Staging in Patients With Locally Advanced Gastric Cancer in Chinese Patients
RATIONALE: Laparoscopic staging may help doctors plan more effective treatment for gastric cancer, yet the efficiency have not been fully investigated in Chinese people.
PURPOSE: Study the effectiveness of laparoscopic staging in patients with pre-diagnosed as locally advanced gastric cancer.
Read the detailed description
OBJECTIVES: I. Determine the feasibility of laparoscopic staging of patients with pre-diagnosed as locally advanced gastric cancer. II. Assess the adverse effects associated with this technique.
OUTLINE: Surgery. Laparoscopy with cytologic examination.
PROJECTED ACCRUAL: Up to 450 patients will be accrued over approximately 2 years.
- Conditions
- Gastric Cancer, Peritoneal Metastases
- Being tested
- Laparoscopic Staging
- Keywords
- Gastric Cancer, Laparoscopic Staging, Cytology, Peritoneal Metastases
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic StagingProcedure or surgery
Laparoscopic Staging
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Staging | Experimental | For Patients diagnosed as Locally Advanced Gastric Cancer(cT2+NanyM0)by CT and EUS, undergo laparoscopic staging. Receives: Procedure: Laparoscopic Staging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peritoneal Metastasis or Positive Cytology
Measured: 7days
Secondary outcomes (1)
Number of Participants with Adverse Events
Number of Participants with Adverse Events(III or IV grades according to NCI-CTC)
Measured: 30days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study start1 Jan 2014
- Primary completion30 Sep 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 452 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiafu Ji, Peking University
- Investigators
- Jiafu Ji, MD, Principal investigator, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02172690
- Sponsor's protocol ID
- KW-LStaging-2014
- Other IDs
- D141100000414004
- Status last verified
- Feb 2025
- First submitted
- 20 Jun 2014
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Li Z, Li Z, Zhang L, Liu Q, Wang Z, Zhang Z, Xiao G, Fu W, Wang X, Ye Y, Yu J, Li F, Chen L, Wang S, Ji J. Staging laparoscopy for locally advanced gastric cancer in Chinese patients: a multicenter prospective registry study. BMC Cancer. 2018 Jan 10;18(1):63. doi: 10.1186/s12885-017-3791-6.
PubMed 29321007
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Staging in Patients With Locally Advanced Gastric Cancer in Chinese Patients
- ClinicalTrials.gov ID
- NCT02172690
- Acronym / sponsor ID
- KW-LStaging-2014
- Conditions
- Gastric Cancer, Peritoneal Metastases
- Keywords
- Gastric Cancer, Laparoscopic Staging, Cytology, Peritoneal Metastases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 452 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 24 Jun 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.
RATIONALE: Laparoscopic staging may help doctors plan more effective treatment for gastric cancer, yet the efficiency have not been fully investigated in Chinese people.
PURPOSE: Study the effectiveness of laparoscopic staging in patients with pre-diagnosed as locally advanced gastric cancer.
Detailed description
OBJECTIVES: I. Determine the feasibility of laparoscopic staging of patients with pre-diagnosed as locally advanced gastric cancer. II. Assess the adverse effects associated with this technique.
OUTLINE: Surgery. Laparoscopy with cytologic examination.
PROJECTED ACCRUAL: Up to 450 patients will be accrued over approximately 2 years.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Staging | Experimental | Procedure: Laparoscopic StagingFor Patients diagnosed as Locally Advanced Gastric Cancer(cT2+NanyM0)by CT and EUS, undergo laparoscopic staging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- sign written informed consent form
- age ≥ 18 years
- pathologically confirmed gastric or GEJ adenocarcinoma
- disease at clinical stage of locally advanced gastric cancer by CT/EUS(cT2+NanyM0)
- No prior antitumor treatment is allowed, including chemotherapy, radiotherapy, immune therapy or target therapy
Key exclusion criteria (11 listed)
- Refuse to provide blood/tissue sample；
- With distant metastasis diagnosed by CT/EUS；
- Sexually active males or females refuse to practice contraception during the study until 30 days after end of study.
- History of organ transplantation（including autologous bone marrow transplantation and Peripheral stem cell transplantation）；
- Prior long term steroid therapy (excluding short term steroid treatment which is completed prior to > 2 weeks of study enrollment)；
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 |
|---|---|---|
| Laparoscopic StagingLaparoscopic Staging | Procedure or surgery | Laparoscopic Staging |
Primary outcome
Peritoneal Metastasis or Positive Cytology
Time frame: 7days
1 secondary outcome
Number of Participants with Adverse Events
Time frame: 30days
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 7 Feb 2025.
- Derived from this study: PubMed 29321007Li Z, Li Z, Zhang L, Liu Q, Wang Z, Zhang Z, Xiao G, Fu W, Wang X, Ye Y, Yu J, Li F, Chen L, Wang S, Ji J. Staging laparoscopy for locally advanced gastric cancer in Chinese patients: a multicenter prospective registry study. BMC Cancer. 2018 Jan 10;18(1):63. doi: 10.1186/s12885-017-3791-6.
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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.
Jiafu Ji, MD principal investigator
Peking University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Staging in people with Gastric Cancer and Peritoneal Metastases, run by Peking 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 11 inclusion and 11 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 7 Feb 2025. 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.
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?
Peritoneal Metastasis or Positive Cytology (time frame: 7days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02172690, which also lists 1 linked publication.
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 Feb 2025.