Clinical Significance of Circulating Tumor Cells (CTCs) in Blood of Patients With Advanced/Metastatic Gastric Cancer
This study is currently recruiting participants.
(see Contacts and Locations)
Verified May 2015 by Peking University
Sponsor:
Peking University
Information provided by (Responsible Party):
Shen Lin, Peking University
ClinicalTrials.gov Identifier:
NCT01625702
First received: June 13, 2012
Last updated: May 17, 2015
Last verified: May 2015
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Purpose
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 | Intervention |
|---|---|
|
Gastric Cancer |
Device: CellSearch® CTC kit |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science |
Resource links provided by NLM:
Further study details as provided by Peking University:
Primary Outcome Measures:
- circulating tumor cells in blood [ Time Frame: every 6 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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. |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01625702
Please refer to this study by its ClinicalTrials.gov identifier: NCT01625702
Contacts
| Contact: LIN SHEN, MD | 861088196561 | LIN100@MEDMAIL.COM.CN |
Locations
| China, Beijing | |
| Department of GI Oncology, Peking University Cancer Hospital | Recruiting |
| Beijing, Beijing, China, 100142 | |
| Contact: Jifang Gong, MD 861088196561 gongjifang@gmail.com | |
| Principal Investigator: Lin Shen, MD | |
Sponsors and Collaborators
Peking University
More Information
| Responsible Party: | Shen Lin, Director of GI oncology, Peking University |
| ClinicalTrials.gov Identifier: | NCT01625702 History of Changes |
| Other Study ID Numbers: | CGOG5001 |
| Study First Received: | June 13, 2012 |
| Last Updated: | May 17, 2015 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by 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 |
ClinicalTrials.gov processed this record on September 28, 2016