ID

15159

Beschreibung

Octreotide LAR as Maintenance Treatment for Patients With NEC; ODM derived from: https://clinicaltrials.gov/show/NCT02409849

Link

https://clinicaltrials.gov/show/NCT02409849

Stichworte

Versionen (2)
  1. 20.05.16 20.05.16 -
  2. 20.05.16 20.05.16 - Julian Varghese
Hochgeladen am

20. Mai 2016

DOI

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Creative Commons BY-NC 3.0
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Eligibility Gastro-entero-pancreatic Carcinoma NCT02409849

Englisch

Eligibility Gastro-entero-pancreatic Carcinoma NCT02409849

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologic diagnosis of high grade (poorly differentiated) gastro-entero-pancreatic neuroendocrine carcinoma.
Beschreibung

Neuroendocrine Tumors Severe Poorly differentiated | Enteroendocrine Cell

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0206754
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0205617
UMLS CUI [2]
C0524979
2. high grade neuroendocrine carcinoma of esophageal or unknown primary site (if a pulmonary primary has been excluded)
Beschreibung

Neuroendocrine Carcinoma Severe | Site Esophageal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0206695
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C1515974
UMLS CUI [2,2]
C1522619
3. metastatic or unresectable disease
Beschreibung

Metastatic Neoplasm | Unresectable Malignant Neoplasm

Datentyp

boolean

Alias
UMLS CUI [1]
C2939420
UMLS CUI [2]
C1336869
4. measurable disease
Beschreibung

Measurable Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1513041
5. accepted chemotherapy with ep or ip regimen for no less than three months
Beschreibung

Chemotherapy Regimen | cisplatin/etoposide protocol | cisplatin/irinotecan

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0078414
UMLS CUI [3]
C0281724
6. effectiveness with cr/pr/sd
Beschreibung

In complete remission | partial response | Stable Disease | Effectiveness

Datentyp

boolean

Alias
UMLS CUI [1]
C0677874
UMLS CUI [2]
C1521726
UMLS CUI [3]
C0677946
UMLS CUI [4]
C1280519
7. informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
8. performance status of 0 or 1
Beschreibung

performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1518965
9. adequate bone marrow function (defined as absolute neutrophil count [anc] >= 1500, platelet count [plt] >= 75,000 and a hemoglobin [hgb] >= 9).
Beschreibung

Bone Marrow Function Adequate | Absolute neutrophil count | Platelet Count measurement | Hemoglobin

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [1,3]
C0205411
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0019046
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.
Beschreibung

Liver function Adequate | Bilirubin, total measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0205411
UMLS CUI [2]
C0201913
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
adequate renal function defined as serum creatinine <= 1.5 mg/dl.
Beschreibung

Normal renal function | Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0232805
UMLS CUI [2]
C0201976
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients who are on ep or ip chemotherapy for less than three months .
Beschreibung

Chemotherapy Regimen | cisplatin/etoposide protocol | cisplatin/irinotecan

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0078414
UMLS CUI [3]
C0281724
2. effectiveness with pd.
Beschreibung

Effectiveness Progressive Disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1280519
UMLS CUI [1,2]
C1335499
3. patients with brain metastases are not eligible.
Beschreibung

Metastatic malignant neoplasm to brain

Datentyp

boolean

Alias
UMLS CUI [1]
C0220650
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.
Beschreibung

Heart failure NYHA class III | Heart failure NYHA class IV | Angina Pectoris | Myocardial Infarction | Congestive heart failure

Datentyp

boolean

Alias
UMLS CUI [1]
C1536132
UMLS CUI [2]
C1536133
UMLS CUI [3]
C0002962
UMLS CUI [4]
C0027051
UMLS CUI [5]
C0018802
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.
Beschreibung

Pregnancy | Breast Feeding | Childbearing Potential Pregnancy test negative Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0427780
UMLS CUI [3,3]
C0700589
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.
Beschreibung

Complicated infection Serious | Illness Non-Malignant Uncontrolled | Therapeutic procedure risk control

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3160894
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C1518371
UMLS CUI [2,3]
C0205318
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C1444641
UMLS CUI [3,3]
C0243148
7. patients with psychiatric disorders rendering them incapable of complying with the requirements of the protocol.
Beschreibung

Mental disorders Compliance behavior Limited

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C1321605
UMLS CUI [1,3]
C0439801
8. patients with serum calcium > 12 mg/dl or symptomatic hypercalcemia under treatment.
Beschreibung

Serum calcium measurement | Therapeutic procedure Hypercalcemia Symptomatic

Datentyp

boolean

Alias
UMLS CUI [1]
C0728876
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0020437
UMLS CUI [2,3]
C0231220
9. patients with osseous metastasis as only site of disease.
Beschreibung

Secondary malignant neoplasm of bone | Site Single Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0153690
UMLS CUI [2,1]
C1515974
UMLS CUI [2,2]
C0205171
UMLS CUI [2,3]
C0012634
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.
Beschreibung

Malignant Neoplasms Concurrent | Skin carcinoma | Carcinoma in situ of uterine cervix

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205420
UMLS CUI [2]
C0699893
UMLS CUI [3]
C0851140
11. patients with known gilbert's syndrome are ineligible.
Beschreibung

Gilbert Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0017551
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Ähnliche Modelle

Eligibility Gastro-entero-pancreatic Carcinoma NCT02409849

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Neuroendocrine Tumors Severe Poorly differentiated | Enteroendocrine Cell
Item
1. histologic diagnosis of high grade (poorly differentiated) gastro-entero-pancreatic neuroendocrine carcinoma.
boolean
C0206754 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205617 (UMLS CUI [1,3])
C0524979 (UMLS CUI [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])
C1515974 (UMLS CUI [2,1])
C1522619 (UMLS CUI [2,2])
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])
Item Group
C0680251 (UMLS CUI)
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
C1536132 (UMLS CUI [1])
C1536133 (UMLS CUI [2])
C0002962 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0018802 (UMLS CUI [5])
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])
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