Clinical Significance of Circulating Tumor Cells (CTCs) in Blood of Patients With Advanced/Metastatic Gastric Cancer

This study is currently recruiting participants.

Verified September 2012 by Peking University

Sponsor:

Information provided by (Responsible Party):

Shen Lin, Peking University

ClinicalTrials.gov Identifier:

NCT01625702

First received: June 13, 2012

Last updated: September 3, 2012

Last verified: September 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

June 13, 2012

Last Updated Date

September 3, 2012

Start Date ^ICMJE

June 2012

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

circulating tumor cells in blood [ Time Frame: every 6 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01625702 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Clinical Significance of Circulating Tumor Cells (CTCs) in Blood of Patients With Advanced/Metastatic Gastric Cancer

Official Title ^ICMJE

Not Provided

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science

Condition ^ICMJE

Gastric Cancer

Intervention ^ICMJE

Device: CellSearch® CTC kit

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.

Study Arm (s)

Experimental: cisplatin plus capecitabine
gastric cancer patients treated with capecitabine/cisplatin

Intervention: Device: CellSearch® CTC kit
Experimental: capecitabine plus paclitaxel
gastric cancer patients treated with capecitabine/paclitaxel

Intervention: Device: CellSearch® CTC kit

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

100

Estimated Completion Date

December 2014

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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
WBC>3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet>100,000/mm3, Hb>9g/dl

Exclusion Criteria:

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: LIN SHEN, MD

861088196561

LIN100@MEDMAIL.COM.CN

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT01625702

Other Study ID Numbers ^ICMJE

CGOG5001

Has Data Monitoring Committee

Not Provided

Responsible Party

Shen Lin, Peking University

Study Sponsor ^ICMJE

Peking University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Peking University

Verification Date

September 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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