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Complications, PostoperativeCLASS-03aNCT03468712

Laparoscopic D2 Distal Gastrectomy Following Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancers

A study testing Laparoscopic D2 distal gastrectomy in people with Complications, Postoperative and Surgery--Complications, run by West China Hospital at 16 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Gastric cancer is the third major cancer of global cancer-related death. In China, the early diagnosis rate of gastric cancer is relatively low, and most patients are with locally advanced tumor stage. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Laparoscopic D2 distal gastrectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
166 participants
Where
16 sitesChina
Study dates
31 Mar 2018to 30 Apr 2023
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • First Round Inclusion Criteria
  • Age from over 18 to under 75 years;
  • Primary gastric adenocarcinoma (including pap, tub, muc, sig, and por) confirmed pathologically by endoscopic biopsy;
  • cT3-4a, N-/+, M0 according to the AJCC 8th Cancer Staging Manual;
  • Without peritoneal metastasis (examined by laparoscopic examination);
  • Radical resection (R0) through distal subtotal gastrectomy with D2 lymphadenectomy is anticipated;
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  • Performance status 0 or 1 (Eastern Cooperative Oncology Group) ;
  • ASA (American Society of Anesthesiology) score ≤ 3;
  • Normal hemodynamic indices:
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  • Blood cell count: HB ≥ 90g/L, ANC ≥ 1.5×109/L, PLT ≥ 80×109/L;
  • Liver and renal function: BIL<1.5 times of the upper limit of normal reference values, ALT and AST<2.5 times of the upper limit of normal reference values, and Crea≤1 time of upper limits of normal reference values.
  • Second Round Inclusion Criteria
  • Therapeutic response rating after neoadjuvant chemotherapy is CR, PR, SD, or Therapeutic response rating after neoadjuvant chemotherapy is PD, tumor is expected to have radical resection;
  • Subjects are still willing to continue participating in this clinical trial.

Who cannot join

  • First Round Exclusion Criteria
  • History of upper abdominal surgery (include endoscopic mucosal resection or endoscopic submucosal dissection, except for laparoscopic cholecystectomy);
  • History of acute pancreatitis;
  • Enlarged or bulky regional lymph node (diameter>3cm) by imaging exam;
  • Patients have received neoadjuvant therapy prior to screen work;
  • History of other malignant disease within the past five years;
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  • History of cerebrovascular accident within the past six months;
  • History of continuous systematic administration of corticosteroids within the past month;
  • Scheduled simultaneous surgery for other disease;
  • Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer;
  • Pyloric obstruction;
  • FEV1<50% of predicted value;
  • Women who are pregnant or lactating at the time of screening;
  • Severe mental disorder;
  • Participating in other clinical studies;
  • Refused to sign the informed consent;
  • Second Round Exclusion Criteria
  • Therapeutic response rating after neoadjuvant chemotherapy is PD, involvement of adjacent structures(T4b), distal metastasis(M1), or enlarged or bulky regional lymph node (diameter>3cm) by preoperative imaging
  • Patients cannot complete 3 cycles of chemotherapy due to intolerance;
  • After 3 cycles of neoadjuvant chemotherapy, patients cannot tolerate surgery due to severe adverse reactions, or ASA score ≥ 4 ;
  • Patients undertake emergency operation due to tumor bleeding, perforation or obstruction during chemotherapy;
  • After signing the informed consent, the patient withdraws from this clinical trial.
  • Withdrawal Criteria After Second Round:
  • Intro-abdominal metastasis of primary cancer is revealed intraoperatively;
  • Primary cancer is confirmed to be un-resectable intraoperatively.

Trial locations and contacts

16 sites in 1 country.

Jian-Kun Hu, M.D. Ph.D. contact

02885422878

hujkwch@126.com

Wei-Han Zhang, M.D. Ph.D. contact

02885422480

16 sites in 1 country

China16 sites, 16 recruiting

  • Peking University Cancer Hospital and Institute

    Beijing, Beijing Municipality, 10000

    Zi-Yu Li, M.D., ligregory369@hotmail.com

    Zi-Yu Li, M.D., Ph.D.

    Not yet recruiting

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality

    Lin Chen

    Not yet recruiting

  • First Hospital of Jilin University

    Changchun, Jilin

    Jian Suo

    Not yet recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

    Jian-Kun Hu

    Jian-Kun Hu

    Recruiting

  • Southwest Hospital, the Third Military Medical University

    Chongqing, Chongqing Municipality, 404100

    Pei-Wu Yu, M.D.,Ph.D.

    Pei-Wu Yu, M.D.,Ph.D.

    Not yet recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian

    Chang-Ming Huang

    Not yet recruiting

  • Guangdong General Hospital

    Guangzhou, Guangdong, 51000

    Yong Li, M.D., Ph.D., liyong-lucky@21cn.com

    Yong Li, M.D., Ph.D.

    Not yet recruiting

  • Nanfang Hospital

    Guangzhou, Guangdong

    Guo-Xin Li

    Not yet recruiting

  • Sir Run Run Shaw Hospital, Zhejiang University

    Hangzhou, Zhejiang

    Yong Wang

    Not yet recruiting

  • Harbin Medical University

    Harbin, Heilonngjiang

    Kuan Wang

    Not yet recruiting

  • The First Affiliated Hospital with Nanjing Medical University

    Nanjing, Jiangsu

    Ze-Kuan Xu

    Not yet recruiting

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200000

    Yi-Hong Sun, M.D., Ph.D., sun.yihong@zs-hospital.sh.cn

    Yi-Hong Sun, M.D., Ph.D.

    Not yet recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality

    Hua Huang

    Not yet recruiting

  • RenJi Hospital, Shanghai Jiaotong University

    Shanghai, Shanghai Municipality

    Gang Zhao

    Not yet recruiting

  • Ruijin Hospital, Shanghai JiaoTong University

    Shanghai, Shanghai Municipality

    Lu Zang

    Not yet recruiting

  • Tangdu Hospital, Fourth Military Medical University

    Xian, Shanxi, 710000

    Xian-Li He, M.D.,Ph.D.

    Xian-Li He, M.D.

    Not yet recruiting

Other trials in China

About this study

Official title: Laparoscopic D2 Distal Gastrectomy Following Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancers: A Prospective Multicenter Trial

Gastric cancer is the third major cancer of global cancer-related death. In China, the early diagnosis rate of gastric cancer is relatively low, and most patients are with locally advanced tumor stage. The neoadjuvant chemotherapy (NAC) can bring the survival advantage for gastric cancer patients with locally advanced tumor stage. The primary goal of NAC is to control the micrometastasis and/or progression of the primary lesion in order to improve potential of radical gastrectomy. NAC is recommended for patients with locally advanced stage (T2-4Nx) according to the latest NCCN Gastric Cancer Guidelines.

Laparoscopy distal gastrectomy (LDG) can achieve a better postoperative short-term recovery than the traditional open distal gastrectomy (ODG), which can reduce the intraoperative blood loss and to shorten the postoperative hospital stay. Therefore, Enhanced Recovery After Surgery program of gastric cancer surgery recommends the use of minimally invasive surgery. For long-term survival outcomes, there is limited evidence supported that laparoscopic gastrectomy is comparable open gastrectomy. Therefore, due to the lack of high-quality prospective clinical trial results, whether advanced tumor is suitable for laparoscopic surgery is still controversial. Therefore, some multi-center prospective randomized controlled trials have been carried out, compared safety and long-term survival outcome between laparoscopic and open gastrectomy in locally advanced gastric cancer patients. CLASS-01 trials reported that for locally advanced gastric cancers, laparoscopic D2 distal gastrectomy is safe and feasible.

Patient's surgical tolerance and stress response may be inhibited after the treatment of NAC. The aim of this trial is to confirm the safety of laparoscopy distal D2 radical gastrectomy for the treatment of after neoadjuvant chemotherapy gastric cancer patients (cT3-4a, N+, M0) in terms of postoperative complications.

Read the detailed description

This is a prospective, multi-centers, open-label, single-arm study, and the aim of this trial is to evaluate the safety of laparoscopic distal D2 radical gastrectomy for the treatment of locally advanced gastric cancer (cT3-4a, N-/+, M0) after neoadjuvant chemotherapy.

Being tested
Laparoscopic D2 distal gastrectomy
Keywords
mortality, morbidity, neoadjuvant chemotherapy, laparoscopic gastrectomy, gastric cancer
Medical subject headings
Postoperative Complications, Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laparoscopic D2 distal gastrectomyProcedure or surgery

    Laparoscopic D2 distal gastrectomy after 3-Cycle XELOX neo-adjuvant chemotherapy

Study groups in NCT03468712
Study groupRoleWhat they receive
Experimental groupExperimentalLaparoscopic D2 distal gastrectomy after 3-Cycle XELOX neo-adjuvant chemotherapy
Receives: Procedure: Laparoscopic D2 distal gastrectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative overall morbidity rate

    The proportion value will be calculated by the number of patients with any operative complication as the numerator and the number of patients undergoing surgical treatment as the denominator.

    Measured: Postoperative 30 days

Secondary outcomes (3)

  1. Postoperative mortality rate

    Mortality will be calculated as the ratio between the number of patients who died as numerator and number of all patients undergoing surgical treatment as the denominator.

    Measured: Postoperative 30 days

  2. R0 resection rate

    Number of patients underwent gastrectomy for the denominator, number of R0 resection patients is numerator, the ratio is the R0 resection rate. The definition of R0 resection is according to the Japanese gastric cancer treatment guidelines 2014 (ver. 4)（Gastric Cancer. 2017 Jan;20(1):1-19.）.

    Measured: The day of surgery

  3. Completion rate of laparoscopic surgery

    Ratio will be calculated with the number of patients complete the laparoscopic gastrectomy as the numerator, and number of all patients undergoing laparoscopic surgical treatment as the denominator.

    Measured: The day of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2018
  2. Study start31 Mar 2018
  3. Primary completion30 Apr 2020 (estimated)
  4. Study completion30 Apr 2023 (estimated)

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Laparoscopic D2 distal gastrectomy after 3-Cycle XELOX neo-adjuvant chemotherapy
Masking
None (open label)
Enrolment
166 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03468712
Sponsor's protocol ID
CLASS-03a
Acronym
CLASS-03a
Status last verified
Mar 2018
First submitted
23 Jan 2018
Last updated
5 Sep 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Pending

Publications

  • Hu Y, Huang C, Sun Y, Su X, Cao H, Hu J, Xue Y, Suo J, Tao K, He X, Wei H, Ying M, Hu W, Du X, Chen P, Liu H, Zheng C, Liu F, Yu J, Li Z, Zhao G, Chen X, Wang K, Li P, Xing J, Li G. Morbidity and Mortality of Laparoscopic Versus Open D2 Distal Gastrectomy for Advanced Gastric Cancer: A Randomized Controlled Trial. J Clin Oncol. 2016 Apr 20;34(12):1350-7. doi: 10.1200/JCO.2015.63.7215. Epub 2016 Feb 22.

    PubMed 26903580

  • Schuhmacher C, Gretschel S, Lordick F, Reichardt P, Hohenberger W, Eisenberger CF, Haag C, Mauer ME, Hasan B, Welch J, Ott K, Hoelscher A, Schneider PM, Bechstein W, Wilke H, Lutz MP, Nordlinger B, Van Cutsem E, Siewert JR, Schlag PM. Neoadjuvant chemotherapy compared with surgery alone for locally advanced cancer of the stomach and cardia: European Organisation for Research and Treatment of Cancer randomized trial 40954. J Clin Oncol. 2010 Dec 10;28(35):5210-8. doi: 10.1200/JCO.2009.26.6114. Epub 2010 Nov 8.

    PubMed 21060024

  • Chen XZ, Yang K, Liu J, Chen XL, Hu JK. Neoadjuvant plus adjuvant chemotherapy benefits overall survival of locally advanced gastric cancer. World J Gastroenterol. 2011 Oct 28;17(40):4542-4. doi: 10.3748/wjg.v17.i40.4542.

    PubMed 22110287

Questions about this trial

What is this clinical trial studying?

A study testing Laparoscopic D2 distal gastrectomy in people with Complications, Postoperative and Surgery--Complications, run by West China Hospital at 16 sites 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 15 inclusion and 25 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 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jian-Kun Hu, M.D. Ph.D. (02885422878, hujkwch@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative overall morbidity rate (time frame: Postoperative 30 days). 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 NCT03468712, which also lists 3 linked publications.

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 5 Sep 2018; AzTrials last refreshed its copy on 6 Nov 2026.

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