NCT01836991

Brief Summary

The purpose of this study is to evaluate the safety and the effect of D2 and D2+ radical surgery for the treatment of advanced distal gastric cancer.

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
200

participants targeted

Target at P75+ for phase_2 gastric-cancer

Timeline
Completed

Started Jan 2012

Typical duration 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

Study Start

First participant enrolled

January 1, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

April 23, 2013

Status Verified

April 1, 2013

Enrollment Period

2 years

First QC Date

April 17, 2013

Last Update Submit

April 22, 2013

Conditions

Gastric Cancer

Keywords

gastric cancersurgerysurgery safetyeffect

Outcome Measures

Primary Outcomes (2)

  • the disease-free survival time

    3 years

  • the overall survival time

    3 years

Study Arms (2)

D2 surgery

OTHER

D2 surgery(No.1、No.3、No.4sb、No.4d、No.5、No.6、No.7 and No.8a、No.9、No.11p、No.12a lymph node)

Procedure: surgery

D2+ surgery

EXPERIMENTAL

D2+ surgery(D2+8p、12b、13、14v lymph node)

Procedure: surgery

Interventions

surgeryPROCEDURE
D2 surgeryD2+ surgery

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female aged 18 to 70 years old.
  • The preoperative evaluation: distal gastric cancer patients, ≥ T2 or N +; or staging II, IIIA, IIIB.
  • Karnofsky score ≥ 70, life expectancy \> 6 months.
  • Endoscopic biopsy diagnosis of gastric cancer, excluding non-Hodgkin's lymphoma, leiomyosarcoma and other mesenchymal tumors.
  • the blood and biochemical indicators of the subjects must meet the following criteria: Hb ≥ 9 g / dl; WBC ≥ 4,000 / mm3, ≤ 12000 / mm3; PLT ≥ 100,000/mm3;
  • GOT, GPT within twice the institutional limit,serum total bilirubin \< 1.5 times the upper limit of normal, serum creatinine\< 1.25 times the upper limit of normal
  • have not received prior chemotherapy, radiotherapy and biological therapy. signed informed consent.
  • must accept the standard D2 or D2 + radical gastrectomy.
  • with good compliance.

You may not qualify if:

  • pregnancy, breast-feeding women.
  • allergy with chemotherapy drugs or metabolic disorder.
  • the history of organ transplants (including bone marrow transplantation and autologous peripheral stem cell transplantation).
  • had long received systemic steroid treatment (Note: short-term users of withdrawal \> 2 weeks can be selected.)
  • The existence of the peripheral nervous system disorders or significant neurological disorders and a history of central nervous system disorders.
  • patients with severe infection requires treatment.
  • patients associated with dysphagia, active peptic ulcer, incompleteness intestinal obstruction, active gastrointestinal bleeding, perforation.
  • severe liver disease (such as cirrhosis), kidney disease, respiratory disease or uncontrollable diabetes.
  • with other malignancies which were not cured.
  • EKG abnormalities or heart disease with apparent clinical symptoms, including congestive heart failure, coronary heart disease with symptoms, uncontrollable arrhythmia, hypertension, and heart attack within 12 months or III or IV grade myocardial infarction. Coronary heart disease with symptoms, uncontrollable arrhythmia, hypertension, and heart attack within 12 months or III or IV grade myocardial infarction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

Related Publications (2)

  • Xu ZY, Hu C, Chen S, Du YA, Huang L, Yu PF, Wang LJ, Cheng XD. Evaluation of D2-plus radical resection for gastric cancer with pyloric invasion. BMC Surg. 2019 Nov 20;19(1):172. doi: 10.1186/s12893-019-0605-6.

    PMID: 31747885DERIVED

  • Yu P, Du Y, Xu Z, Huang L, Cheng X. Comparison of D2 and D2 plus radical surgery for advanced distal gastric cancer: a randomized controlled study. World J Surg Oncol. 2019 Feb 6;17(1):28. doi: 10.1186/s12957-019-1572-1.

    PMID: 30728027DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • xiangdong Cheng

    Zhejiang Cancer Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

xiangdong Cheng, MD

CONTACT

+86 571 88122516ypfzmu@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2013

First Posted

April 22, 2013

Study Start

January 1, 2012

Primary Completion

January 1, 2014

Study Completion

January 1, 2017

Last Updated

April 23, 2013

Record last verified: 2013-04

Locations

CN(1)