Eligibility Carcinoma of Unknown Primary NCT00148135

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StudyEvent: Eligibility
1. Eligibility Carcinoma of Unknown Primary NCT00148135

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

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])

Exclusion Criteria

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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Eligibility Carcinoma of Unknown Primary NCT00148135