NCT01471470

Brief Summary

The purpose of this study is to determine whether docetaxel, capecitabine, cisplatin, and bevacizumab are effective in the treatment of unresectable advanced gastric cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2010

Longer than P75 for phase_2

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

July 1, 2010

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 18, 2011

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 15, 2011

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

January 7, 2020

Status Verified

January 1, 2020

Enrollment Period

7.4 years

First QC Date

July 18, 2011

Last Update Submit

January 6, 2020

Conditions

Advanced Gastric Cancer

Keywords

Advanced gastric cancerNeoadjuvantBevacizumab

Outcome Measures

Primary Outcomes (1)

  • R0 resection rate

    R0 resection means complete resection of tumor.

    Up to 4 weeks after surgery

Secondary Outcomes (4)

  • Overall survival

    Up to 3 years

  • Progression-free survival

    Up to 3 years

  • Adverse Event

    Up to 28 days after end of treatment

  • Angiogenetic biomarkers

    Baseline and 6 weeks after treatment

Study Arms (1)

neoadjuvant

EXPERIMENTAL
Drug: Docetaxel, Capecitabine, Cisplatin, Bevacizumab

Interventions

Docetaxel, Capecitabine, Cisplatin, BevacizumabDRUG

Bevacizumab 7.5mg/kg IV (D1) Docetaxel 60 mg/m2 IV (D1) Cisplatin 60 mg/m2 IV (D1) Xeloda 1,875 mg/m2/day/bid PO (D1-D14)

neoadjuvant

Eligibility Criteria

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

You may qualify if:

  • Histologically documented adenocarcinoma of the stomach or gastroesophageal junction.
  • Invasion to adjacent organ (T4) proven by endoscopic ultrasonography (EUS) or presence of paraaortic lymph node metastasis by CT and PET(short-axis diameter \> 1 cm showing hot uptake in PET scan).
  • Age 18-70 years old
  • ECOG performance status 0-2
  • Adequate hepatic function(serum bilirubin \<1.5mg/dl, AST (SGOT) and ALT (SGPT) \< 2.5 x UNL, alkaline phosphatase \< 5 x UNL)
  • Adequate renal function(serum creatinine \<1.5mg/dl)
  • Adequate bone marrow function (WBC ≥4000 cell/㎕ with ANC ≥1500 cell/㎕, platelet count ≥100,000 cell/㎕)
  • HER2 negative (HER2 immunohistochemistry 0 or 1+, immunohistochemistry 2+ but FISH negative)
  • Informed consent

You may not qualify if:

  • Other histologic type than adenocarcinoma
  • Metastasis in other sites than paraaortic lymph nodes, like in liver or peritoneum.
  • Presence or history of other cancers
  • History of prior chemotherapy, antiangiogenic agents, or radiation.
  • Patients with definite ascites in abdomen CT scan
  • Presence of not adequately controlled CNS metastasis
  • Bowel obstruction
  • Evidence of gastrointestinal bleeding
  • Other serious illness or medical conditions including hypertension uncontrolled by medication.
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

MeSH Terms

Interventions

DocetaxelCapecitabineCisplatinBevacizumab

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Yoon-Koo Kang, MD, PhD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 18, 2011

First Posted

November 15, 2011

Study Start

July 1, 2010

Primary Completion

December 1, 2017

Study Completion

July 1, 2018

Last Updated

January 7, 2020

Record last verified: 2020-01

Locations

KR(1)