NCT01625702

Brief Summary

To identify the correlation of CTCs with clinical prognosis in advanced/metastatic gastric cancer. Confirm the presence of CTCs are sensitive for monitoring response to chemotherapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
138

participants targeted

Target at P50-P75 for not_applicable gastric-cancer

Timeline
Completed

Started Jun 2012

Typical duration for not_applicable 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

June 1, 2012

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 21, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

May 9, 2017

Status Verified

May 1, 2017

Enrollment Period

2.1 years

First QC Date

June 13, 2012

Last Update Submit

May 7, 2017

Conditions

Gastric Cancer

Keywords

no-prior chemotherapy

Outcome Measures

Primary Outcomes (1)

  • circulating tumor cells in blood

    every 6 weeks

Study Arms (2)

cisplatin plus capecitabine

EXPERIMENTAL

gastric cancer patients treated with capecitabine/cisplatin

Device: CellSearch® CTC kit

capecitabine plus paclitaxel

EXPERIMENTAL

gastric cancer patients treated with capecitabine/paclitaxel

Device: CellSearch® CTC kit

Interventions

CellSearch® CTC kitDEVICE

Collect peripheral blood sample of 100 gastric cancer patients pre-chemotherapy treated with capecitabine/paclitaxel (XPa) and capecitabine/cisplatin (XP) and post two cycles of chemotherapy(response evaluation). Blood samples will be transferred to central lab to detect CTCs by Cellsearch kit. Tumor response evaluation will be performed after two cycles of chemotherapy by CT/MRI based on RECIST. Clinical data, including tumor stage, metastastic organ, chemotherapy regimen, objective response, progression free survival, overall survival, etc, will be collected according to study protocol.

capecitabine plus paclitaxelcisplatin plus capecitabine

Eligibility Criteria

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

You may qualify if:

  • Having signed informed consent
  • Age≥ 18 years old
  • Histologically confirmed gastric adenocarcinoma
  • Unresectable recurrent or metastatic disease
  • Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months
  • Previous chemotherapy with capecitabine or cisplatin, if applicable, more than 12 months.
  • Measurable disease according to the RECIST criteria
  • Karnofsky performance status ≥60
  • Life expectancy of ≥2 month
  • No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks
  • ALT and AST\<2.5 times ULN (≤5 times ULN in patients with liver metastases)
  • Serum albumin level ≥3.0g/dL
  • Serum AKP \< 2.5 times ULN
  • Serum creatinine \<ULN, and CCr \< 60ml/min
  • Bilirubin level \< 1.5 ULN
  • +1 more criteria

You may not qualify if:

  • Brain metastasis (known or suspected)
  • Previous systemic therapy for metastatic gastric cancer
  • Inability to take oral medication
  • Previous therapy targeting at angiogenesis or vasculogenesis pathway or other targeted therapy
  • Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry Contraindications of nuclear magnetic resonance image such as fitment of cardiac pacemaker , nerve stimulator, or aneurysm clip, and metallic foreign body in eye ball and so on.
  • Allergic constitution or allergic history to protium biologic product or any investigating agents.
  • Severe heart disease or such history as recorded congestive heart failure, uncontrolled cardiac arrhythmia, angina pectoris needing medication, cardiac valve disease, severe abnormal ECG findings, cardiac infarction , or retractable hypertension.
  • Pregnancy or lactation period
  • Any investigational agent within the past 28 days
  • Other previous malignancy within 5 year, except non-melanoma skin cancer
  • Previous adjuvant therapy with capecitabine+platinum,
  • Pre-existing neuropathy\>grade 1
  • Legal incapacity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of GI Oncology, Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Related Publications (1)

  • Li Y, Peng Z, Zhang X, Gong J, Shen L. [Value of serum human epithelial growth factor receptor 2 extracellular domain and circulating tumor cells in evaluating therapeutic response in advanced gastric cancer]. Zhonghua Wei Chang Wai Ke Za Zhi. 2017 Nov 25;20(11):1293-1299. Chinese.

    PMID: 29178102DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of GI oncology

Study Record Dates

First Submitted

June 13, 2012

First Posted

June 21, 2012

Study Start

June 1, 2012

Primary Completion

July 1, 2014

Study Completion

December 1, 2015

Last Updated

May 9, 2017

Record last verified: 2017-05

Locations

CN(1)