ID

24624

Description

Chemotherapy and Avastin Followed by Maintenance Treatment With Avastin +/- Tarceva; ODM derived from: https://clinicaltrials.gov/show/NCT00598156

Link

https://clinicaltrials.gov/show/NCT00598156

Keywords

  1. 8/9/17 8/9/17 -
Uploaded on

August 9, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Metastatic Colorectal Cancer NCT00598156

Eligibility Metastatic Colorectal Cancer NCT00598156

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. adenocarcinoma of the colon or rectum.
Description

Adenocarcinoma of colon | Adenocarcinoma of rectum

Data type

boolean

Alias
UMLS CUI [1]
C0338106
UMLS CUI [2]
C0149978
2. age > 18.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3. measurable disease according to recist criteria.
Description

Measurable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
4. expected survival more than three months.
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
5. adequate bone marrow, liver and kidney function.
Description

Bone Marrow function | Liver function | Renal function

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
6. inr < 1.5 times upper limit.
Description

International Normalized Ratio

Data type

boolean

Alias
UMLS CUI [1]
C0525032
7. adequate contraception for fertile patients.
Description

Fertility Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
8. signed written informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. earlier chemotherapy for metastatic colorectal cancer.
Description

Chemotherapy Colorectal cancer metastatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0948380
2. adjuvant treatment within 6 months.
Description

Adjuvant therapy

Data type

boolean

Alias
UMLS CUI [1]
C0677850
3. surgery or significant trauma within 28 days prior to study entry.
Description

Operative Surgical Procedures | Trauma

Data type

boolean

Alias
UMLS CUI [1]
C0543467
UMLS CUI [2]
C3714660
4. planned radiotherapy against target lesions.
Description

Therapeutic radiology procedure Planned Target Lesion

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C1301732
UMLS CUI [1,3]
C1521840
UMLS CUI [1,4]
C0221198
5. cns metastases.
Description

CNS metastases

Data type

boolean

Alias
UMLS CUI [1]
C0686377
6. prior malignancy within 5 years except ca in situ of cervix and basal cell carcinoma.
Description

Malignant Neoplasms | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0851140
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
7. bleeding diathesis
Description

Bleeding tendency

Data type

boolean

Alias
UMLS CUI [1]
C1458140
8. uncontrolled hypertension.
Description

Uncontrolled hypertension

Data type

boolean

Alias
UMLS CUI [1]
C1868885
9. significant cardiovascular disease.
Description

Cardiovascular Disease

Data type

boolean

Alias
UMLS CUI [1]
C0007222
10. treatment with anticoagulant drugs.
Description

Anticoagulants

Data type

boolean

Alias
UMLS CUI [1]
C0003280
11. participation in other clinical trial.
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
12. pregnant or lactating.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147

Similar models

Eligibility Metastatic Colorectal Cancer NCT00598156

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of colon | Adenocarcinoma of rectum
Item
1. adenocarcinoma of the colon or rectum.
boolean
C0338106 (UMLS CUI [1])
C0149978 (UMLS CUI [2])
Age
Item
2. age > 18.
boolean
C0001779 (UMLS CUI [1])
Measurable Disease
Item
3. measurable disease according to recist criteria.
boolean
C1513041 (UMLS CUI [1])
Life Expectancy
Item
4. expected survival more than three months.
boolean
C0023671 (UMLS CUI [1])
Bone Marrow function | Liver function | Renal function
Item
5. adequate bone marrow, liver and kidney function.
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
International Normalized Ratio
Item
6. inr < 1.5 times upper limit.
boolean
C0525032 (UMLS CUI [1])
Fertility Contraceptive methods
Item
7. adequate contraception for fertile patients.
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Informed Consent
Item
8. signed written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chemotherapy Colorectal cancer metastatic
Item
1. earlier chemotherapy for metastatic colorectal cancer.
boolean
C0392920 (UMLS CUI [1,1])
C0948380 (UMLS CUI [1,2])
Adjuvant therapy
Item
2. adjuvant treatment within 6 months.
boolean
C0677850 (UMLS CUI [1])
Operative Surgical Procedures | Trauma
Item
3. surgery or significant trauma within 28 days prior to study entry.
boolean
C0543467 (UMLS CUI [1])
C3714660 (UMLS CUI [2])
Therapeutic radiology procedure Planned Target Lesion
Item
4. planned radiotherapy against target lesions.
boolean
C1522449 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C1521840 (UMLS CUI [1,3])
C0221198 (UMLS CUI [1,4])
CNS metastases
Item
5. cns metastases.
boolean
C0686377 (UMLS CUI [1])
Malignant Neoplasms | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma
Item
6. prior malignancy within 5 years except ca in situ of cervix and basal cell carcinoma.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
Bleeding tendency
Item
7. bleeding diathesis
boolean
C1458140 (UMLS CUI [1])
Uncontrolled hypertension
Item
8. uncontrolled hypertension.
boolean
C1868885 (UMLS CUI [1])
Cardiovascular Disease
Item
9. significant cardiovascular disease.
boolean
C0007222 (UMLS CUI [1])
Anticoagulants
Item
10. treatment with anticoagulant drugs.
boolean
C0003280 (UMLS CUI [1])
Study Subject Participation Status
Item
11. participation in other clinical trial.
boolean
C2348568 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
12. pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

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