NCT01618474

Brief Summary

This trial is going to evaluate the efficacy and safety of two regimens of DX (docetaxel plus capecitabine)and XELOX (oxaliplatin plus capecitabine)as adjuvant chemotherapy for stage IIIb-IIIc gastric cancer patients after curative D2/D2+ operation, and to investigate the optimal adjuvant regimen for such extremely high risk patients.

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
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2012

Typical duration for phase_2

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

May 1, 2012

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2012

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 13, 2012

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 22, 2015

Status Verified

May 1, 2012

Enrollment Period

4.5 years

First QC Date

May 27, 2012

Last Update Submit

December 21, 2015

Conditions

Stomach Cancer

Keywords

gastric canceradjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

  • disease free survival

    DFS was difined as the length of time from the date of randomization to the date of first documentation of relapse of gastric cancer or any other type of cancer or death.

    3 years

Secondary Outcomes (2)

  • overall survival

    3 years

  • CTC negative conversion rate

    3 years

Study Arms (2)

DX

EXPERIMENTAL

DX: Docetaxel 60mg/m2, intravenous infusion, day 1; Capecitabine 1000mg/m2, oral administration, twice a day, day1-14; 3 weeks a cycle for 8 consecutive cycles.

Drug: DX

XELOX

ACTIVE COMPARATOR

XELOX: oxaliplatin 130mg/m2, intravenous infusion, day 1; Capecitabine 1000mg/m2, oral administration, twice a day, day 1-14, 3 weeks a cycle for 8 consecutive cycles

Drug: XELOX

Interventions

DXDRUG

Docetaxel 60mg/m2, intravenous infusion, day 1; Capecitabine 1000mg/m2, oral administration, twice a day, day1-14; 3 weeks a cycle for 8 consecutive cycles.

Also known as: Docetaxel, Xeloda
DX
XELOXDRUG

oxaliplatin 130mg/m2, intravenous infusion, day 1; Capecitabine 1000mg/m2, oral administration, twice a day, day 1-14, 3 weeks a cycle for 8 consecutive cycles

Also known as: Eloxatin, XEloda
XELOX

Eligibility Criteria

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

You may qualify if:

  • a post operation histologically confirmed gastric or esophagogastric junction adenocarcinoma;
  • curative D2 or D2+ operation had been performed, and the pathological stage post operation was verified as IIIb or IIIc;
  • no adjuvant chemotherapy before or after operation;
  • Karnofsky performance status scale ≥ 70;
  • prior adjuvant chemotherapy that did not include taxanes and S-1;
  • white blood count ≥ 3,500/mm3, absolute neutrophil count ≥ 1,500/mm3, platelet count ≥ 100,000/mm3, hemoglobin count ≥ 90 g/dL, serum bilirubin level \< 1.5 of the upper limit of normal (ULN) for the institution, aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase ≤ 2.5 ULN, serum albumin ≥ 30g/L, serum creatinine ≤ 1.5 ULN; and
  • normal cardiac function with no severe heart disease.

You may not qualify if:

  • pregnancy or breast feeding;
  • past history of allergy to taxanes, platinum and 5-fluorouracil or their analogues;
  • radiotherapy for all measurable target lesions;
  • obstructive bowel disease;
  • past history of other cancers except for cured non-melanoma skin cancer or cervical cancer; and
  • concomitant treatment with other anticancer drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

DocetaxelCapecitabineXELOXOxaliplatin

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesCoordination Complexes

Study Officials

  • Dingzhi Huang, M.D.

    Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Hospital

    PRINCIPAL INVESTIGATOR

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

May 27, 2012

First Posted

June 13, 2012

Study Start

May 1, 2012

Primary Completion

November 1, 2016

Study Completion

December 1, 2016

Last Updated

December 22, 2015

Record last verified: 2012-05

Locations

CN(1)