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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 November 2015 |
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Main ID: |
NCT02590055 |
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Date of registration:
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27/10/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Phase 2 Study of Gemcitabine and Docetaxel Combination Chemotherapy in Patients With Carcinoma of Unknown Primary
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Scientific title:
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Phase 2 Study of Gemcitabine and Docetaxel Combination Chemotherapy in Patients With Carcinoma of Unknown Primary |
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Date of first enrolment:
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October 2015 |
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Target sample size:
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29 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02590055 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Yoon Jung Ahn |
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Address:
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Telephone:
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Email:
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younjeong.ahn@samsung.com |
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Affiliation:
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Name:
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Su Jin Lee, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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department of medicine, Samsung Medical Center |
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Name:
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Yoon Jung Ahn |
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Address:
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Telephone:
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Email:
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younjeong.ahn@samsung.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 1. age>=20 2. pathologically confirmed patients with carcinoma of unknown primary 3.
unfavorable type of CUP 4. ECOG PS 0-2 5. more than 1 evaluable lesion 6. life
expectancy > 12 weeks 7. no prior history of chemotherapy 8. more than 2 weeks after
surgery or radiotherapy 9. proper organ function 10. written informed consent
Exclusion Criteria:
- 1. favorable group CUP
- squamous cell carcinoma in the cervical or inguinal LN only women with axillary
LN metastasis only women with peritoneal carcinomatosis only well-differentiated
neuroendocrine tumors poorly-differentiated tumors with midline tumor or
elevated human HCG/AFP men with adenocarcinoma and elevated PSA 2. severe,
unstable heart disease 3. uncontrolled systemic disease (DM, HTN,
hypothyroidism, infection...) 4. pregnant or feeding women 5. current CNS tumor
(except total removal or WBRT/GKS done)
Age minimum:
20 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Carcinoma of Unknown Primary
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Intervention(s)
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Drug: gemcitabine/docetaxel combination
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Primary Outcome(s)
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Overall survival
[Time Frame: one year after later patients enrolled]
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Secondary ID(s)
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2015-03-083
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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