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

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ClinicalTrials.gov Identifier: NCT01625702
Recruitment Status : Completed
First Posted : June 21, 2012
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
Shen Lin, Peking University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Device: CellSearch® CTC kit Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Study Start Date : June 2012
Actual Primary Completion Date : July 2014
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: cisplatin plus capecitabine
gastric cancer patients treated with capecitabine/cisplatin
 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.
Experimental: capecitabine plus paclitaxel
gastric cancer patients treated with capecitabine/paclitaxel
 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.


Outcome Measures
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Primary Outcome Measures :
  1. circulating tumor cells in blood [ Time Frame: every 6 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01625702


Locations
China, Beijing
Department of GI Oncology, Peking University Cancer Hospital
Beijing, Beijing, China, 100142
Sponsors and Collaborators
Peking University
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Shen Lin, Director of GI oncology, Peking University
ClinicalTrials.gov Identifier: NCT01625702     History of Changes
Other Study ID Numbers: CGOG5001
First Posted: June 21, 2012    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017

Keywords provided by Shen Lin, Peking University:
no-prior chemotherapy

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Paclitaxel
Cisplatin
 Capecitabine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites