NCT02404753

Brief Summary

The purpose of the study is to evaluate the safety and efficacy of laparoscopic distal D2 gastrectomy (LDG) compared with open surgery (ODG) for resectable gastric cancer, to determine whether LDG can be a test arm for a future Phase III trial to evaluate the non-inferiority of overall survival compared with ODG in patients who receive neoadjuvant chemotherapy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P75+ for phase_2 gastric-cancer

Timeline
Completed

Started Apr 2015

Longer than P75 for phase_2 gastric-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 31, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2022

Completed
Last Updated

September 28, 2018

Status Verified

September 1, 2018

Enrollment Period

5.7 years

First QC Date

March 23, 2015

Last Update Submit

September 26, 2018

Conditions

Gastric Cancer

Keywords

Locally advanced gastric cancerLaparoscopic distal D2 gastrectomyNeoadjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

  • 3-year progression-free survival

    In terms of locally advanced gastric cancer, to evaluate the disease free survival rate in laparoscopic subtotal gastrectomy with D2 lymph node dissection at postoperative 3 years compared with open subtotal gastrectomy with D2 lymph node dissection

    36 months

Secondary Outcomes (5)

  • Overall survival

    36 months

  • Surgical morbidity

    30 days

  • Surgical mortality

    30 days

  • Postoperative recovery index

    2 weeks

  • Postoperative quality of life

    Up to 1 year post-operative

Study Arms (2)

Laparoscopic gastrectomy

EXPERIMENTAL

Laparoscopic distal gastrectomy and D2 lymph node dissection are performed for locally advanced gastric cancer after neoadjuvant chemotherapy.

Drug: Neoadjuvant ChemotherapyProcedure: Laparoscopic gastrectomyDrug: Adjuvant Chemotherapy

Open gastrectomy

ACTIVE COMPARATOR

Open distal gastrectomy and D2 lymph node dissection are performed for locally advanced gastric cancer after neoadjuvant chemotherapy.

Drug: Neoadjuvant ChemotherapyProcedure: Open gastrectomyDrug: Adjuvant Chemotherapy

Interventions

Neoadjuvant ChemotherapyDRUG

XELOX: Oxaliplatin 130mg/m2,iv.,d1;Capecitabine 1000mg/m2,po.,Bid,d1-14; Repeat every 21 days for 3 courses.

Also known as: NACT
Laparoscopic gastrectomyOpen gastrectomy
Laparoscopic gastrectomyPROCEDURE

Laparoscopic distal gastrectomy with D2 lymph node dissection

Also known as: LDG
Laparoscopic gastrectomy
Open gastrectomyPROCEDURE

Open distal gastrectomy with D2 lymph node dissection

Also known as: ODG
Open gastrectomy
Adjuvant ChemotherapyDRUG

XELOX: Oxaliplatin 130mg/m2,iv.,d1;Capecitabine 1000mg/m2,po.,Bid,d1-14; Repeat every 21 days for 5 courses.

Also known as: ACT
Laparoscopic gastrectomyOpen gastrectomy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically proven adenocarcinoma of the stomach.
  • Clinical cT2N+M0,or cT3-4a/N+M0 disease, confirmed by upper gastrointestinal endoscopy and abdominal computed tomography (CT) and laparoscopy. The T and N stages are determined by the method of Habermann et al.
  • The gastric tumors are located in the middle to lower third of the stomach, are macroscopically resectable by distal gastrectomy with D2 lymph node dissection, and R0 or R1 resection can be achieved.
  • No bulky lymph node metastasis is detected by abdominal CT.
  • No pleural effusion, no ascites exceeding the pelvis and no metastasis to the peritoneum, liver or other distant organs are confirmed by abdominal pelvic CT.
  • No clinically apparent distant metastasis.
  • Karnofsky performance status ≥70%.
  • Sufficient oral intake.
  • No previous treatment with chemotherapy or radiation therapy for any tumors.
  • No previous surgery for the present disease.
  • Sufficient organ function, as evaluated by laboratory tests 7 days or more after the date when the anticancer drugs were given. When patients are recovering from myelosuppression,the revised criteria are shown in parentheses.
  • White blood cell count≥3000/mm3 (2000/mm3) Platelet count≥10.0\*104/mm3 (5.0\*104/mm3) Aspartate aminotransferase≤100 IU/l Alanine aminotransferase≤100 IU/l Total bilirubin≤2.0 mg/dl Serum creatinine≤1.5 mg/dl
  • No need for emergency surgery due to bleeding or perforation of the primary tumor.
  • No mechanical obstruction.
  • Written informed consent.

You may not qualify if:

  • Past history of upper abdominal surgery.
  • Past history of surgery for the gastrointestinal tract.
  • Body mass index exceeding 30 kg/m2.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Related Publications (3)

  • Li Z, Shan F, Ying X, Zhang L, Ren H, Li S, Jia Y, Miao R, Xue K, Li Z, Wang Y, Yan C, Zhang Y, Pang F, Ji J. Laparoscopic or open distal gastrectomy after neoadjuvant chemotherapy for advanced gastric cancer: study protocol for a randomised phase II trial. BMJ Open. 2018 Aug 10;8(8):e021633. doi: 10.1136/bmjopen-2018-021633.

    PMID: 30099396BACKGROUND

  • Li Z, Shan F, Wang Y, Li S, Jia Y, Zhang L, Yin D, Ji J. Laparoscopic versus open distal gastrectomy for locally advanced gastric cancer after neoadjuvant chemotherapy: safety and short-term oncologic results. Surg Endosc. 2016 Oct;30(10):4265-71. doi: 10.1007/s00464-015-4739-z. Epub 2016 Jun 10.

    PMID: 27287914BACKGROUND

  • Li Z, Shan F, Ying X, Zhang Y, E JY, Wang Y, Ren H, Su X, Ji J. Assessment of Laparoscopic Distal Gastrectomy After Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancer: A Randomized Clinical Trial. JAMA Surg. 2019 Dec 1;154(12):1093-1101. doi: 10.1001/jamasurg.2019.3473.

    PMID: 31553463DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Neoadjuvant TherapyChemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug Therapy

Study Officials

  • Ziyu Li, M.D.

    Peking University Cancer Hospital & Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician,Associate Professor

Study Record Dates

First Submitted

March 23, 2015

First Posted

March 31, 2015

Study Start

April 1, 2015

Primary Completion

November 25, 2020

Study Completion

November 25, 2022

Last Updated

September 28, 2018

Record last verified: 2018-09

Locations

CN(1)