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
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:
Show all 11Show fewer
- 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；
Show all 11Show fewer
- 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.
- 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