ID

12985

Description

Combination of Carboplatin, Gemcitabine, and Capecitabine in Patients With Carcinoma of Unknown Primary Site; ODM derived from: https://clinicaltrials.gov/show/NCT00148135

Link

https://clinicaltrials.gov/show/NCT00148135

Keywords

Versions (1)
  1. 1/10/16 1/10/16 -
Uploaded on

January 10, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Carcinoma of Unknown Primary NCT00148135

English

Eligibility Carcinoma of Unknown Primary NCT00148135

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologic or cytologic diagnosis of carcinoma, with clinical evidence of metastasis and the primary site not clear after the following work-up:
Description

carcinoma unknown primary

Data type

boolean

Alias
UMLS CUI [1,1]
C0019638
UMLS CUI [1,2]
C0007097
UMLS CUI [2,1]
C0010819
UMLS CUI [2,2]
C0007097
UMLS CUI [3]
C0086691
complete history and physical
Description

history, physical

Data type

boolean

Alias
UMLS CUI [1]
C0679831
UMLS CUI [2]
C0031809
laboratory evaluation including serum beta-human chorionic gonadotropin (hcg), serum alpha-fetoprotein for undifferentiated or poorly differentiated carcinomas and serum prostate specific antigen (psa) in men.
Description

b-hcg, afp, psa

Data type

boolean

Alias
UMLS CUI [1]
C1880076
UMLS CUI [2]
C0201539
UMLS CUI [3]
C0201544
directed radiologic evaluation including, at a minimum, computerized tomography (ct) of chest, abdomen and pelvis and bilateral mammography for female patients.
Description

radiologic exams

Data type

boolean

Alias
UMLS CUI [1]
C0043299
UMLS CUI [2]
C0040405
UMLS CUI [3]
C0024671
pathologic immunohistochemistry studies of the surgical or biopsy specimen, including studies for estrogen receptor/progesterone receptor and psa stains when clinically appropriate.
Description

immunohistochemistry

Data type

boolean

Alias
UMLS CUI [1]
C0021044
patients must be at least 18 years of age and have a zubrod performance status 0-2.
Description

age, zubrod

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C3714786
adequate organ function, defined as absolute neutrophil count (anc) > 1500/ul, platelet count of > 100,000/ul, serum creatinine less than or equal to 2.0 mg/dl, serum bilirubin less than or equal to 1.5 mg/dl.
Description

anc, platelet count, creatinine, bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0201976
UMLS CUI [4]
C1278039
patients must have measurable disease. (partial response [pr] - at least a 30% decrease in the sum of ld of target lesions taking as reference the baseline sum ld.)
Description

measurable disease, partial response

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1521726
patients may be previously untreated or have received one chemotherapy regimen provided it did not include carboplatin, gemcitabine or capecitabine.
Description

chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
patients must have no serious intercurrent medical or psychiatric illness that would limit their ability to provide informed consent or receive protocol therapy.
Description

comorbidity

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
patients must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to the initiation of therapy.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with previous invasive malignancy within the preceding 5 years are ineligible unless clinicopathologic information regarding the current neoplasm is clearly discordant from prior disease. patients with non-melanoma skin cancer or in situ cancer of any site are eligible.
Description

malignancy

Data type

boolean

Alias
UMLS CUI [1]
C0006826
patients with brain metastasis are not eligible.
Description

brain metastases

Data type

boolean

Alias
UMLS CUI [1]
C0220650
no concurrent chemotherapy, biological or radiotherapy is allowed.
Description

concurrent therapy

Data type

boolean

Alias
UMLS CUI [1]
C0009429
pregnant or lactating women are not eligible. women and men of childbearing potential must agree to use effective contraception throughout the treatment period, and for six months after treatment has been discontinued.
Description

pregnancy, breastfeeding, contraception

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0700589
the following groups of patients will not be eligible for the study as they represent populations of patients with cup for whom more specific treatment approaches are available:
Description

carcinoma of unknown primary

Data type

boolean

Alias
UMLS CUI [1]
C0220647
1. patients presenting with squamous carcinoma isolated to middle and high cervical lymph nodes
Description

squamous carcinoma, cervical lymph nodes

Data type

boolean

Alias
UMLS CUI [1]
C0007137
UMLS CUI [2]
C0588054
2. women presenting with isolated axillary lymphadenopathy
Description

gender, isolated axillary lymphadenopathy

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0578735
UMLS CUI [2,2]
C0205409
3. women presenting with predominant peritoneal carcinomatosis
Description

gender, peritoneal carcinomatosis

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0346990
4. men < 50 years of age presenting with predominant mediastinal and/or retroperitoneal nodal involvement and biopsy showing undifferentiated or poorly differentiated carcinoma.
Description

gender, age, lymph nodes, differentiation

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0686651
UMLS CUI [4]
C0686661
UMLS CUI [5]
C1511938
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Similar models

Eligibility Carcinoma of Unknown Primary NCT00148135

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
carcinoma unknown primary
Item
histologic or cytologic diagnosis of carcinoma, with clinical evidence of metastasis and the primary site not clear after the following work-up:
boolean
C0019638 (UMLS CUI [1,1])
C0007097 (UMLS CUI [1,2])
C0010819 (UMLS CUI [2,1])
C0007097 (UMLS CUI [2,2])
C0086691 (UMLS CUI [3])
history, physical
Item
complete history and physical
boolean
C0679831 (UMLS CUI [1])
C0031809 (UMLS CUI [2])
b-hcg, afp, psa
Item
laboratory evaluation including serum beta-human chorionic gonadotropin (hcg), serum alpha-fetoprotein for undifferentiated or poorly differentiated carcinomas and serum prostate specific antigen (psa) in men.
boolean
C1880076 (UMLS CUI [1])
C0201539 (UMLS CUI [2])
C0201544 (UMLS CUI [3])
radiologic exams
Item
directed radiologic evaluation including, at a minimum, computerized tomography (ct) of chest, abdomen and pelvis and bilateral mammography for female patients.
boolean
C0043299 (UMLS CUI [1])
C0040405 (UMLS CUI [2])
C0024671 (UMLS CUI [3])
immunohistochemistry
Item
pathologic immunohistochemistry studies of the surgical or biopsy specimen, including studies for estrogen receptor/progesterone receptor and psa stains when clinically appropriate.
boolean
C0021044 (UMLS CUI [1])
age, zubrod
Item
patients must be at least 18 years of age and have a zubrod performance status 0-2.
boolean
C0001779 (UMLS CUI [1])
C3714786 (UMLS CUI [2])
anc, platelet count, creatinine, bilirubin
Item
adequate organ function, defined as absolute neutrophil count (anc) > 1500/ul, platelet count of > 100,000/ul, serum creatinine less than or equal to 2.0 mg/dl, serum bilirubin less than or equal to 1.5 mg/dl.
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
measurable disease, partial response
Item
patients must have measurable disease. (partial response [pr] - at least a 30% decrease in the sum of ld of target lesions taking as reference the baseline sum ld.)
boolean
C1513041 (UMLS CUI [1])
C1521726 (UMLS CUI [2])
chemotherapy
Item
patients may be previously untreated or have received one chemotherapy regimen provided it did not include carboplatin, gemcitabine or capecitabine.
boolean
C0392920 (UMLS CUI [1])
comorbidity
Item
patients must have no serious intercurrent medical or psychiatric illness that would limit their ability to provide informed consent or receive protocol therapy.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
informed consent
Item
patients must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to the initiation of therapy.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
malignancy
Item
patients with previous invasive malignancy within the preceding 5 years are ineligible unless clinicopathologic information regarding the current neoplasm is clearly discordant from prior disease. patients with non-melanoma skin cancer or in situ cancer of any site are eligible.
boolean
C0006826 (UMLS CUI [1])
brain metastases
Item
patients with brain metastasis are not eligible.
boolean
C0220650 (UMLS CUI [1])
concurrent therapy
Item
no concurrent chemotherapy, biological or radiotherapy is allowed.
boolean
C0009429 (UMLS CUI [1])
pregnancy, breastfeeding, contraception
Item
pregnant or lactating women are not eligible. women and men of childbearing potential must agree to use effective contraception throughout the treatment period, and for six months after treatment has been discontinued.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
carcinoma of unknown primary
Item
the following groups of patients will not be eligible for the study as they represent populations of patients with cup for whom more specific treatment approaches are available:
boolean
C0220647 (UMLS CUI [1])
squamous carcinoma, cervical lymph nodes
Item
1. patients presenting with squamous carcinoma isolated to middle and high cervical lymph nodes
boolean
C0007137 (UMLS CUI [1])
C0588054 (UMLS CUI [2])
gender, isolated axillary lymphadenopathy
Item
2. women presenting with isolated axillary lymphadenopathy
boolean
C0079399 (UMLS CUI [1])
C0578735 (UMLS CUI [2,1])
C0205409 (UMLS CUI [2,2])
gender, peritoneal carcinomatosis
Item
3. women presenting with predominant peritoneal carcinomatosis
boolean
C0079399 (UMLS CUI [1])
C0346990 (UMLS CUI [2])
gender, age, lymph nodes, differentiation
Item
4. men < 50 years of age presenting with predominant mediastinal and/or retroperitoneal nodal involvement and biopsy showing undifferentiated or poorly differentiated carcinoma.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0686651 (UMLS CUI [3])
C0686661 (UMLS CUI [4])
C1511938 (UMLS CUI [5])
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