ID

36398

Description

Recombinant Anti-tumor and Anti-virus Protein for Injection Plus Xeloda in Treatment of Metastatic Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02068131

Link

https://clinicaltrials.gov/show/NCT02068131

Keywords

Versions (1)
  1. 5/10/19 5/10/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 10, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Metastatic Colorectal Cancer NCT02068131

English

Eligibility Metastatic Colorectal Cancer NCT02068131

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
aged above 18 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
pathologically confirmed metastatic adenocarcinoma of the colon or rectum. all other histological types are excluded.
Description

Adenocarcinoma of colon metastatic | Adenocarcinoma of rectum metastatic

Data type

boolean

Alias
UMLS CUI [1]
C4324497
UMLS CUI [2,1]
C0149978
UMLS CUI [2,2]
C1522484
failure of second-line and more than second-line treatment, and fluoropyrimidine- and irinotecan- and oxaliplatin-containing regimens.(subjects who progress during or within 3 months following the last administration of approved standard therapies and terminate standard treatment due to unacceptable toxicity warranting.).if recurrence and metastasis occurred within 6 months after discontinuation of adjuvant chemotherapy, the adjuvant chemotherapy is considered to be first-line treatment.subject received last-line treatment not including capecitabine.
Description

Second line treatment failed | fluoropyrimidine | irinotecan | oxaliplatin | Disease Progression Following Standard therapy | Standard therapy Discontinued Due to Toxicity | Recurrent disease | Neoplasm Metastasis | Adjuvant Chemotherapy First line treatment | Capecitabine Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C1710038
UMLS CUI [1,2]
C0231175
UMLS CUI [2]
C0596581
UMLS CUI [3]
C0123931
UMLS CUI [4]
C0069717
UMLS CUI [5,1]
C0242656
UMLS CUI [5,2]
C0332282
UMLS CUI [5,3]
C2936643
UMLS CUI [6,1]
C2936643
UMLS CUI [6,2]
C1444662
UMLS CUI [6,3]
C0678226
UMLS CUI [6,4]
C0600688
UMLS CUI [7]
C0277556
UMLS CUI [8]
C0027627
UMLS CUI [9,1]
C0085533
UMLS CUI [9,2]
C1708063
UMLS CUI [10,1]
C0671970
UMLS CUI [10,2]
C0332197
at least one measurable lesion according to the recist criteria that has not been previously local treated. minimum indicator lesion size as follows: greater than or equal to 10 mm measured by spiral ct or nmr.malignant lymph nodes short diameter as follows: greater than or equal to 15 mm measured by spiral ct.
Description

Measurable Disease Quantity | Lesion size Spiral CT | Lesion size MRI | Lymph nodes Malignant Diameter Spiral CT

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0449453
UMLS CUI [2,2]
C0860888
UMLS CUI [3,1]
C0449453
UMLS CUI [3,2]
C0024485
UMLS CUI [4,1]
C0024204
UMLS CUI [4,2]
C0205282
UMLS CUI [4,3]
C1301886
UMLS CUI [4,4]
C0860888
ecog performance status 0, 1 or 2.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
minimum of 4 weeks since any local radiotherapy or surgery for the control of symptoms or severe complications(local radiotherapy for the control of bone metastases is not the limit)，and adequately recovered from toxicities of any prior therapy).
Description

Therapeutic radiology procedure Local Symptom control | Operative Surgical Procedures Local Symptom control | Therapeutic radiology procedure Local | Operative Surgical Procedures Local | Control Complications Severe | Toxicity Due to Prior Therapy | Patient recovered

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0205276
UMLS CUI [1,3]
C1274136
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0205276
UMLS CUI [2,3]
C1274136
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0205276
UMLS CUI [4,1]
C0543467
UMLS CUI [4,2]
C0205276
UMLS CUI [5,1]
C2587213
UMLS CUI [5,2]
C0009566
UMLS CUI [5,3]
C0205082
UMLS CUI [6,1]
C0600688
UMLS CUI [6,2]
C0678226
UMLS CUI [6,3]
C1514463
UMLS CUI [7]
C1115804
life expectancy of at least 3 months.
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior treatment with novaferon.
Description

Novaferon

Data type

boolean

Alias
UMLS CUI [1]
C3273451
pregnancy or breast-feeding women or women who may be pregnant were positive drug test before administration.
Description

Pregnancy | Breast Feeding | Possible pregnancy | Pregnancy test positive

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0425965
UMLS CUI [4]
C0240802
patient of child-bearing potential(male or less than 1 year postmenopausal women) were reluctant to take contraceptive measures.
Description

Females & males of reproductive potential Contraceptive methods Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
patient who were allergic to interferon-α or who had interferon-α antibody.
Description

Hypersensitivity Interferon-alpha | Interferon-alpha Antibody

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0002199
UMLS CUI [2,1]
C0002199
UMLS CUI [2,2]
C0003241
patients with uncontrolled central nervous system (cns) metastases.
Description

CNS metastases Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0205318
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Similar models

Eligibility Metastatic Colorectal Cancer NCT02068131

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
aged above 18 years.
boolean
C0001779 (UMLS CUI [1])
Adenocarcinoma of colon metastatic | Adenocarcinoma of rectum metastatic
Item
pathologically confirmed metastatic adenocarcinoma of the colon or rectum. all other histological types are excluded.
boolean
C4324497 (UMLS CUI [1])
C0149978 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
Second line treatment failed | fluoropyrimidine | irinotecan | oxaliplatin | Disease Progression Following Standard therapy | Standard therapy Discontinued Due to Toxicity | Recurrent disease | Neoplasm Metastasis | Adjuvant Chemotherapy First line treatment | Capecitabine Absent
Item
failure of second-line and more than second-line treatment, and fluoropyrimidine- and irinotecan- and oxaliplatin-containing regimens.(subjects who progress during or within 3 months following the last administration of approved standard therapies and terminate standard treatment due to unacceptable toxicity warranting.).if recurrence and metastasis occurred within 6 months after discontinuation of adjuvant chemotherapy, the adjuvant chemotherapy is considered to be first-line treatment.subject received last-line treatment not including capecitabine.
boolean
C1710038 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0596581 (UMLS CUI [2])
C0123931 (UMLS CUI [3])
C0069717 (UMLS CUI [4])
C0242656 (UMLS CUI [5,1])
C0332282 (UMLS CUI [5,2])
C2936643 (UMLS CUI [5,3])
C2936643 (UMLS CUI [6,1])
C1444662 (UMLS CUI [6,2])
C0678226 (UMLS CUI [6,3])
C0600688 (UMLS CUI [6,4])
C0277556 (UMLS CUI [7])
C0027627 (UMLS CUI [8])
C0085533 (UMLS CUI [9,1])
C1708063 (UMLS CUI [9,2])
C0671970 (UMLS CUI [10,1])
C0332197 (UMLS CUI [10,2])
Measurable Disease Quantity | Lesion size Spiral CT | Lesion size MRI | Lymph nodes Malignant Diameter Spiral CT
Item
at least one measurable lesion according to the recist criteria that has not been previously local treated. minimum indicator lesion size as follows: greater than or equal to 10 mm measured by spiral ct or nmr.malignant lymph nodes short diameter as follows: greater than or equal to 15 mm measured by spiral ct.
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0449453 (UMLS CUI [2,1])
C0860888 (UMLS CUI [2,2])
C0449453 (UMLS CUI [3,1])
C0024485 (UMLS CUI [3,2])
C0024204 (UMLS CUI [4,1])
C0205282 (UMLS CUI [4,2])
C1301886 (UMLS CUI [4,3])
C0860888 (UMLS CUI [4,4])
ECOG performance status
Item
ecog performance status 0, 1 or 2.
boolean
C1520224 (UMLS CUI [1])
Therapeutic radiology procedure Local Symptom control | Operative Surgical Procedures Local Symptom control | Therapeutic radiology procedure Local | Operative Surgical Procedures Local | Control Complications Severe | Toxicity Due to Prior Therapy | Patient recovered
Item
minimum of 4 weeks since any local radiotherapy or surgery for the control of symptoms or severe complications(local radiotherapy for the control of bone metastases is not the limit)，and adequately recovered from toxicities of any prior therapy).
boolean
C1522449 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C1274136 (UMLS CUI [1,3])
C0543467 (UMLS CUI [2,1])
C0205276 (UMLS CUI [2,2])
C1274136 (UMLS CUI [2,3])
C1522449 (UMLS CUI [3,1])
C0205276 (UMLS CUI [3,2])
C0543467 (UMLS CUI [4,1])
C0205276 (UMLS CUI [4,2])
C2587213 (UMLS CUI [5,1])
C0009566 (UMLS CUI [5,2])
C0205082 (UMLS CUI [5,3])
C0600688 (UMLS CUI [6,1])
C0678226 (UMLS CUI [6,2])
C1514463 (UMLS CUI [6,3])
C1115804 (UMLS CUI [7])
Life Expectancy
Item
life expectancy of at least 3 months.
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Novaferon
Item
prior treatment with novaferon.
boolean
C3273451 (UMLS CUI [1])
Pregnancy | Breast Feeding | Possible pregnancy | Pregnancy test positive
Item
pregnancy or breast-feeding women or women who may be pregnant were positive drug test before administration.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0425965 (UMLS CUI [3])
C0240802 (UMLS CUI [4])
Females & males of reproductive potential Contraceptive methods Unwilling
Item
patient of child-bearing potential(male or less than 1 year postmenopausal women) were reluctant to take contraceptive measures.
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Hypersensitivity Interferon-alpha | Interferon-alpha Antibody
Item
patient who were allergic to interferon-α or who had interferon-α antibody.
boolean
C0020517 (UMLS CUI [1,1])
C0002199 (UMLS CUI [1,2])
C0002199 (UMLS CUI [2,1])
C0003241 (UMLS CUI [2,2])
CNS metastases Uncontrolled
Item
patients with uncontrolled central nervous system (cns) metastases.
boolean
C0686377 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
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