NCT03399253

Brief Summary

Our study aims to compare the efficacy and safety of Chemotherapy Alone Versus D2 distal gastrectomy and metastasectomy plus Chemotherapy for gastric cancer (GC) with one non-curable Factor

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
120

participants targeted

Target at P75+ for phase_2 gastric-cancer

Timeline
Completed

Started Dec 2017

Longer than P75 for phase_2 gastric-cancer

Geographic Reach
1 country

9 active sites

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

December 10, 2017

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 16, 2018

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 16, 2018

Status Verified

January 1, 2018

Enrollment Period

4.9 years

First QC Date

January 8, 2018

Last Update Submit

January 8, 2018

Conditions

Gastric Cancer

Keywords

Distal Gastric Cancer, Gastrectomy, Metastasectomy

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    OS

    5-year

Secondary Outcomes (1)

  • progression free survival

    3-year

Study Arms (2)

Chemotherapy

ACTIVE COMPARATOR

chemotherapy with capecitabine and oxaliplatin (eight 3-week cycles of oral capecitabine 1000 mg/m² twice daily on days 1-14 plus intravenous oxaliplatin 130 mg/m² on day 1) for 6 months or progress of disease

Drug: chemotherapy

Surgery+Chemotherapy

EXPERIMENTAL

D2 Gastrectomy and Metastasectomy + chemotherapy with capecitabine and oxaliplatin (eight 3-week cycles of oral capecitabine 1000 mg/m² twice daily on days 1-14 plus intravenous oxaliplatin 130 mg/m² on day 1) for 6 months or progress of disease

Procedure: surgeryDrug: chemotherapy

Interventions

surgeryPROCEDURE

D2 gastrectomy + metastasectomy

Surgery+Chemotherapy
chemotherapyDRUG

capecitabine and oxaliplatin (eight 3-week cycles of oral capecitabine 1000 mg/m² twice daily on days 1-14 plus intravenous oxaliplatin 130 mg/m² on day 1) for 6 months or progress of disease

Also known as: XELOX
ChemotherapySurgery+Chemotherapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Lower age limit of research subjects 18 years old and upper age limit of 75 years old.
  • PS (ECOG) of 0 or 1.
  • Without any other malignancies.
  • Written informed consent from the patient.
  • Standard gastrectomy with D2 lymphadenectomy for primary cancer
  • A single non-curable factor was defined by preoperative CT :
  • hepatic metastasis (H1 or H2; maximum diameter ≤4 cm, number ≤4); peritoneal metastasis (R0 or R1 resection) para-aortic lymph node metastasis （number ≤4) ovarian metastasis adrenal metastasis renal metastasis
  • No contraindications to chemotherapy, including normal peripheral blood routine, liver and kidney function and electrocardiogram （WBC≥4.0 x 109 /L, NEU≥1.5 x 109 /L,PLT≥100 x 109 /L and HGB≥90g/L)

You may not qualify if:

  • Female in pregnancy or lactation.
  • Supraclavicular lymph nodes metastases，lung and bone metastases.
  • Massive ascites or cachexia.
  • Extensive cancer metastases of liver, peritoneal metastasis,para-aortic lymph node
  • Patients participating in any other clinical trails currently，or participated in other trails within 1 months.
  • Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases.
  • Poor treatment compliance of patients
  • The group of chemotherapy alone accepts gastrectomy for bleeding or obstruction
  • Failure of R0 or R1 metastasectomy and gastrectomy with D2 lymphadenectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Anqing Municipal Hospital

Anqing, Anhui, China

RECRUITING

Anhui Provincial Hospital

Hefei, Anhui, China

RECRUITING

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

RECRUITING

First Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, China

RECRUITING

Cancer Center of Sun Yat-sen University

Guangzhou, Guangdong, China

RECRUITING

Yuebei People's Hospital

Guangzhou, Guangdong, China

RECRUITING

Jiangxi Provincial Cancer Hospital

Nanchang, Jiangxi, China

RECRUITING

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Surgical Procedures, OperativeDrug TherapyXELOX

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Dazhi Xu, PHD

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dazhi Xu, PHD

CONTACT

(+86) 020-87343737xudzh@sysucc.org.cn

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
professor

Study Record Dates

First Submitted

January 8, 2018

First Posted

January 16, 2018

Study Start

December 10, 2017

Primary Completion

November 1, 2022

Study Completion

December 1, 2025

Last Updated

January 16, 2018

Record last verified: 2018-01

Locations

CN(9)