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

Gastric Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01625702
• Other study ID #: CGOG5001
• Status: Completed
• Phase: N/A
• First received: June 13, 2012
• Last updated: May 7, 2017
• Start date: June 2012
• Est. completion date: December 2015

Study information

• Verified date: May 2017
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: December 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Department of GI Oncology, Peking University Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	circulating tumor cells in blood		every 6 weeks