ID

20216

Description

A Study of 1018 Immunostimulatory Sequence (ISS) Administered With Irinotecan and Cetuximab to Treat Patients With Previously Treated Metastatic Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00403052

Link

https://clinicaltrials.gov/show/NCT00403052

Keywords

Versions (1)
  1. 2/14/17 2/14/17 -
Uploaded on

February 14, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Colorectal Neoplasms NCT00403052

English

Eligibility Colorectal Neoplasms NCT00403052

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed, written, informed consent must be obtained from the patient or their legal representative before any study-specific procedures are performed
Description

Informed Consent | Informed Consent Patient Representatives

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
confirmed diagnosis of adenocarcinoma of the colon or rectum not amenable to curative surgery
Description

Adenocarcinoma of colon Amenable Curative Surgery | Adenocarcinoma of rectum Amenable Curative Surgery

Data type

boolean

Alias
UMLS CUI [1,1]
C0338106
UMLS CUI [1,2]
C3900053
UMLS CUI [1,3]
C1511562
UMLS CUI [2,1]
C0149978
UMLS CUI [2,2]
C3900053
UMLS CUI [2,3]
C1511562
one or more prior systemic therapy regimens for metastatic cancer which must have included a fluoropyrimidine (5-fluorouracil (fu) by infusion or capecitabine), oxaliplatin or irinotecan with or without bevacizumab
Description

systemic therapy Quantity Neoplasm Metastasis | fluoropyrimidine | Fluorouracil Infusion | capecitabine | oxaliplatin | irinotecan | bevacizumab

Data type

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0027627
UMLS CUI [2]
C0596581
UMLS CUI [3,1]
C0016360
UMLS CUI [3,2]
C0574032
UMLS CUI [4]
C0671970
UMLS CUI [5]
C0069717
UMLS CUI [6]
C0123931
UMLS CUI [7]
C0796392
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
clinically significant obstructive symptoms, intestinal bleeding, or chronic or recent acute gastrointestinal disorder with diarrhea as a major symptom
Description

Symptoms Obstructive | Intestinal hemorrhage | Gastrointestinal Diseases chronic | Gastrointestinal Diseases | Diarrhea Symptoms Major

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0549186
UMLS CUI [2]
C0267373
UMLS CUI [3,1]
C0017178
UMLS CUI [3,2]
C0205191
UMLS CUI [4]
C0017178
UMLS CUI [5,1]
C0011991
UMLS CUI [5,2]
C1457887
UMLS CUI [5,3]
C0205164
history of unstable or deteriorating cardiovascular or cerebrovascular disease within 3 months before the first dose of protocol therapy
Description

Cardiovascular Disease Unstable | Cardiovascular Disease Worsening | Cerebrovascular Disorder Unstable | Cerebrovascular Disorder Worsening

Data type

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0007222
UMLS CUI [2,2]
C0332271
UMLS CUI [3,1]
C0007820
UMLS CUI [3,2]
C0443343
UMLS CUI [4,1]
C0007820
UMLS CUI [4,2]
C0332271
clinical evidence of brain metastases or central nervous system disease
Description

Metastatic malignant neoplasm to brain Evidence Clinical | CNS disorder Evidence Clinical

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C3887511
UMLS CUI [1,3]
C0205210
UMLS CUI [2,1]
C0007682
UMLS CUI [2,2]
C3887511
UMLS CUI [2,3]
C0205210
pregnant or lactating women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
serious medical or psychiatric illness
Description

Disease Serious | Serious mental illness

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C3841614
malignancy other than colorectal carcinoma within the past 2 years, except curatively treated, superficial skin cancer or carcinoma in situ of the cervix
Description

Malignant Neoplasms | Colorectal Carcinoma | Skin carcinoma Superficial Curative treatment | Carcinoma in situ of uterine cervix Curative treatment

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0009402
UMLS CUI [3,1]
C0699893
UMLS CUI [3,2]
C0205124
UMLS CUI [3,3]
C1273390
UMLS CUI [4,1]
C0851140
UMLS CUI [4,2]
C1273390
patients who have been on any experimental study or anti-tumor therapy, received radiotherapy, or had prior surgery (except venous access device placement) within 28 days before the first dose of protocol therapy
Description

Research study participation | cancer treatment | Therapeutic radiology procedure | Operative Surgical Procedures | Venous access device implantation

Data type

boolean

Alias
UMLS CUI [1,1]
C0681814
UMLS CUI [1,2]
C0679823
UMLS CUI [2]
C0920425
UMLS CUI [3]
C1522449
UMLS CUI [4]
C0543467
UMLS CUI [5]
C1700941
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Similar models

Eligibility Colorectal Neoplasms NCT00403052

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent | Informed Consent Patient Representatives
Item
signed, written, informed consent must be obtained from the patient or their legal representative before any study-specific procedures are performed
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Adenocarcinoma of colon Amenable Curative Surgery | Adenocarcinoma of rectum Amenable Curative Surgery
Item
confirmed diagnosis of adenocarcinoma of the colon or rectum not amenable to curative surgery
boolean
C0338106 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C1511562 (UMLS CUI [1,3])
C0149978 (UMLS CUI [2,1])
C3900053 (UMLS CUI [2,2])
C1511562 (UMLS CUI [2,3])
systemic therapy Quantity Neoplasm Metastasis | fluoropyrimidine | Fluorouracil Infusion | capecitabine | oxaliplatin | irinotecan | bevacizumab
Item
one or more prior systemic therapy regimens for metastatic cancer which must have included a fluoropyrimidine (5-fluorouracil (fu) by infusion or capecitabine), oxaliplatin or irinotecan with or without bevacizumab
boolean
C1515119 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
C0596581 (UMLS CUI [2])
C0016360 (UMLS CUI [3,1])
C0574032 (UMLS CUI [3,2])
C0671970 (UMLS CUI [4])
C0069717 (UMLS CUI [5])
C0123931 (UMLS CUI [6])
C0796392 (UMLS CUI [7])
Item Group
C0680251 (UMLS CUI)
Symptoms Obstructive | Intestinal hemorrhage | Gastrointestinal Diseases chronic | Gastrointestinal Diseases | Diarrhea Symptoms Major
Item
clinically significant obstructive symptoms, intestinal bleeding, or chronic or recent acute gastrointestinal disorder with diarrhea as a major symptom
boolean
C1457887 (UMLS CUI [1,1])
C0549186 (UMLS CUI [1,2])
C0267373 (UMLS CUI [2])
C0017178 (UMLS CUI [3,1])
C0205191 (UMLS CUI [3,2])
C0017178 (UMLS CUI [4])
C0011991 (UMLS CUI [5,1])
C1457887 (UMLS CUI [5,2])
C0205164 (UMLS CUI [5,3])
Cardiovascular Disease Unstable | Cardiovascular Disease Worsening | Cerebrovascular Disorder Unstable | Cerebrovascular Disorder Worsening
Item
history of unstable or deteriorating cardiovascular or cerebrovascular disease within 3 months before the first dose of protocol therapy
boolean
C0007222 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2,1])
C0332271 (UMLS CUI [2,2])
C0007820 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0007820 (UMLS CUI [4,1])
C0332271 (UMLS CUI [4,2])
Metastatic malignant neoplasm to brain Evidence Clinical | CNS disorder Evidence Clinical
Item
clinical evidence of brain metastases or central nervous system disease
boolean
C0220650 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
C0007682 (UMLS CUI [2,1])
C3887511 (UMLS CUI [2,2])
C0205210 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Disease Serious | Serious mental illness
Item
serious medical or psychiatric illness
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C3841614 (UMLS CUI [2])
Malignant Neoplasms | Colorectal Carcinoma | Skin carcinoma Superficial Curative treatment | Carcinoma in situ of uterine cervix Curative treatment
Item
malignancy other than colorectal carcinoma within the past 2 years, except curatively treated, superficial skin cancer or carcinoma in situ of the cervix
boolean
C0006826 (UMLS CUI [1])
C0009402 (UMLS CUI [2])
C0699893 (UMLS CUI [3,1])
C0205124 (UMLS CUI [3,2])
C1273390 (UMLS CUI [3,3])
C0851140 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
Research study participation | cancer treatment | Therapeutic radiology procedure | Operative Surgical Procedures | Venous access device implantation
Item
patients who have been on any experimental study or anti-tumor therapy, received radiotherapy, or had prior surgery (except venous access device placement) within 28 days before the first dose of protocol therapy
boolean
C0681814 (UMLS CUI [1,1])
C0679823 (UMLS CUI [1,2])
C0920425 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0543467 (UMLS CUI [4])
C1700941 (UMLS CUI [5])
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