NCT01711242

Brief Summary

The objective of the trial is to compare disease-free survival between adjuvant XELOX alone vs XELOX with concurrent capecitabine and radiotherapy in curatively resected gastric cancer patients with D2 dissection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
208

participants targeted

Target at P75+ for phase_2 gastric-cancer

Timeline
Completed

Started Jan 2012

Longer than P75 for phase_2 gastric-cancer

Geographic Reach
1 country

1 active site

Status
completed

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
10 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 22, 2012

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

May 5, 2022

Status Verified

April 1, 2022

Enrollment Period

8 years

First QC Date

October 14, 2012

Last Update Submit

April 29, 2022

Conditions

Gastric Cancer

Keywords

gastric cancerradiotherapypostoperative therapychemotherapy

Outcome Measures

Primary Outcomes (1)

  • disease free survival

    3-year

Secondary Outcomes (1)

  • 5 year Overall Survival

    5 years

Other Outcomes (2)

  • Health-related quality of life

    five years after enrollment

  • Number of participants with adverse events as a measure of safety and tolerability

    during treatment

Study Arms (2)

capecitabine/Oxaliplatin/radiotherapy

EXPERIMENTAL

sequence chemoradiotherapy following radical resection sequence chemoradiotherapy two cycles of XELOX + concurrent chemoradiotherapy + two cycles of XELOX. Postoperative radiotherapy regimen: Radiotherapy consisted of 4500 centigray of radiation at 180 centigray per day, five days per week for five weeks, to the tumor bed, to the margins of resection or the stoma, to the regional nodes. Protection of spinal cord, heart, liver and kidney should be considered. Concurrent chemotherapy regimen: capecitabine 825 mg/m² twice daily Postoperative chemotherapy regimen: see arm 2

Drug: CapecitabineDrug: OxaliplatinRadiation: Radiotherapy

capecitabine/Oxaliplatin

ACTIVE COMPARATOR

chemotherapy alone following radical resection Drug: chemotherapy alone following radical resection Postoperative chemotherapy regimen: The XELOX regimen was administrated: Oxaliplatin, 130mg/m2/day on day1, i.v. 2h; Capecitabine 1000mg/m²/day twice daily d1-14; every 21 days repeated, for 4 cycles.

Drug: CapecitabineDrug: Oxaliplatin

Interventions

CapecitabineDRUG
capecitabine/Oxaliplatincapecitabine/Oxaliplatin/radiotherapy
OxaliplatinDRUG
capecitabine/Oxaliplatincapecitabine/Oxaliplatin/radiotherapy
RadiotherapyRADIATION
capecitabine/Oxaliplatin/radiotherapy

Eligibility Criteria

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

You may qualify if:

  • Histologically proven gastric cancer; ≥ D2 resection
  • Stage T1-4, N+
  • ≤ age ≤ 75
  • Eastern Cooperative Oncology Group 0-2
  • No distant metastasis
  • Adequate bone marrow functions (absolute neutrophil count≥ 1,500/ul, blood platelet≥ 100,000/ul, haemoglobin≥ 10g/dl)
  • Adequate renal functions(serum creatinine ≤ 1.5mg/dl)
  • Adequate liver functions (serum bilirubin ≤ 1.5mg/dl, aspartate aminotransferase/alanine aminotransferase ≤ 3 times(normal value)
  • Written informed consent

You may not qualify if:

  • Previous history of immunotherapy, chemotherapy, radiotherapy for gastric cancer;
  • Active infection requiring antibiotics;
  • Pregnant, lactating women;
  • Psychiatric illness, epileptic disorders;
  • Concurrent systemic illness not appropriate for chemotherapy;
  • Resection margin (+);
  • History of other malignancy within 5 years except for non-melanoma skin cancer, cervix in situ carcinoma;
  • D0, D1 resection;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Wenzhou Medical College

Wenzhou, Zhejiang, 325000, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

CapecitabineOxaliplatinRadiotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesCoordination ComplexesOrganic ChemicalsTherapeutics

Study Officials

  • congying xie, MD

    First Affiliated Hospital of Wenzhou Medical University

    PRINCIPAL INVESTIGATOR

  • xiaolei chen, MD

    First Affiliated Hospital of Wenzhou Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

October 14, 2012

First Posted

October 22, 2012

Study Start

January 1, 2012

Primary Completion

January 1, 2020

Study Completion

January 1, 2021

Last Updated

May 5, 2022

Record last verified: 2022-04

Locations

CN(1)