Neuroendocrine Tumors Severe Poorly differentiated | Enteroendocrine Cell
Item
1. histologic diagnosis of high grade (poorly differentiated) gastro-entero-pancreatic neuroendocrine carcinoma.
boolean
C2987127 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Neuroendocrine Carcinoma Severe | Site Esophageal
Item
2. high grade neuroendocrine carcinoma of esophageal or unknown primary site (if a pulmonary primary has been excluded)
boolean
C0206695 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1522619 (UMLS CUI [1,3])
Metastatic Neoplasm | Unresectable Malignant Neoplasm
Item
3. metastatic or unresectable disease
boolean
C2939420 (UMLS CUI [1])
C1336869 (UMLS CUI [2])
Measurable Disease
Item
4. measurable disease
boolean
C1513041 (UMLS CUI [1])
Chemotherapy Regimen | cisplatin/etoposide protocol | cisplatin/irinotecan
Item
5. accepted chemotherapy with ep or ip regimen for no less than three months
boolean
C0392920 (UMLS CUI [1])
C0078414 (UMLS CUI [2])
C0281724 (UMLS CUI [3])
In complete remission | partial response | Stable Disease | Effectiveness
Item
6. effectiveness with cr/pr/sd
boolean
C0677874 (UMLS CUI [1])
C1521726 (UMLS CUI [2])
C0677946 (UMLS CUI [3])
C1280519 (UMLS CUI [4])
Informed Consent
Item
7. informed consent
boolean
C0021430 (UMLS CUI [1])
performance status
Item
8. performance status of 0 or 1
boolean
C1518965 (UMLS CUI [1])
Bone Marrow Function Adequate | Absolute neutrophil count | Platelet Count measurement | Hemoglobin
Item
9. adequate bone marrow function (defined as absolute neutrophil count [anc] >= 1500, platelet count [plt] >= 75,000 and a hemoglobin [hgb] >= 9).
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0205411 (UMLS CUI [1,3])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0019046 (UMLS CUI [4])
Liver function Adequate | Bilirubin, total measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
10. adequate hepatic function with a bilirubin of <= 2.0 mg/dl, and aspartate aminotransferase (ast or sgot) and alanine aminotransferase (alt or sgpt) <= 2.5 times the upper limits of normal, unless caused by liver metastasis. if caused by metastasis, then should be sgpt and sgot <= 5 times the upper limits of normal.
boolean
C0232741 (UMLS CUI [1,1])
C0205411 (UMLS CUI [1,2])
C0201913 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
Normal renal function | Creatinine measurement, serum
Item
adequate renal function defined as serum creatinine <= 1.5 mg/dl.
boolean
C0232805 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Chemotherapy Regimen | cisplatin/etoposide protocol | cisplatin/irinotecan
Item
1. patients who are on ep or ip chemotherapy for less than three months .
boolean
C0392920 (UMLS CUI [1])
C0078414 (UMLS CUI [2])
C0281724 (UMLS CUI [3])
Effectiveness Progressive Disease
Item
2. effectiveness with pd.
boolean
C1280519 (UMLS CUI [1,1])
C1335499 (UMLS CUI [1,2])
Metastatic malignant neoplasm to brain
Item
3. patients with brain metastases are not eligible.
boolean
C0220650 (UMLS CUI [1])
Heart failure NYHA class III | Heart failure NYHA class IV | Angina Pectoris | Myocardial Infarction | Congestive heart failure
Item
4. patients with new york heart association (nyha) class iii or iv heart disease are not eligible as well as those patients with history of angina, myocardial infarction, or congestive heart failure within six months.
boolean
C1275491 (UMLS CUI [1])
C0002962 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0018802 (UMLS CUI [4])
Pregnancy | Breast Feeding | Childbearing Potential Pregnancy test negative Contraceptive methods
Item
5. pregnant or lactating women. all women of child bearing potential must have a negative pregnancy test prior to entry into the study. all patients of child bearing potential must be advised of the importance of avoiding pregnancy and using appropriate methods of contraception while participating in this investigational trial.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])
Complicated infection Serious | Illness Non-Malignant Uncontrolled | Therapeutic procedure risk control
Item
6. patients with serious complicated infections, or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this therapy.
boolean
C3160894 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0221423 (UMLS CUI [2,1])
C1518371 (UMLS CUI [2,2])
C0205318 (UMLS CUI [2,3])
C0087111 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C0243148 (UMLS CUI [3,3])
Mental disorders Compliance behavior Limited
Item
7. patients with psychiatric disorders rendering them incapable of complying with the requirements of the protocol.
boolean
C0004936 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
Serum calcium measurement | Therapeutic procedure Hypercalcemia Symptomatic
Item
8. patients with serum calcium > 12 mg/dl or symptomatic hypercalcemia under treatment.
boolean
C0728876 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0020437 (UMLS CUI [2,2])
C0231220 (UMLS CUI [2,3])
Secondary malignant neoplasm of bone | Site Single Disease
Item
9. patients with osseous metastasis as only site of disease.
boolean
C0153690 (UMLS CUI [1])
C1515974 (UMLS CUI [2,1])
C0205171 (UMLS CUI [2,2])
C0012634 (UMLS CUI [2,3])
Malignant Neoplasms Concurrent | Skin carcinoma | Carcinoma in situ of uterine cervix
Item
10. patients with any concurrent active malignancy other than non-melanoma skin cancers or carcinoma-in-situ of the cervix. patients with previous malignancies but without evidence of disease for > 5 years will be allowed to enter the trial.
boolean
C0006826 (UMLS CUI [1,1])
C0205420 (UMLS CUI [1,2])
C0699893 (UMLS CUI [2])
C0851140 (UMLS CUI [3])
Gilbert Disease
Item
11. patients with known gilbert's syndrome are ineligible.
boolean
C0017551 (UMLS CUI [1])