ID

20199

Description

A Phase III Trial Comparing UFT+PSK to UFT+LV in Stage IIB, III Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00385970

Link

https://clinicaltrials.gov/show/NCT00385970

Keywords

Versions (1)
  1. 2/12/17 2/12/17 -
Uploaded on

February 12, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT00385970

English

Eligibility Colorectal Cancer NCT00385970

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with ptnm stage iib or iii (uicc sixth version) primary colon cancer/rectal cancer who have undergone surgery of histological curability a (including laparoscopic surgery) (the curability is judged after surgery)
Description

Colon Carcinoma Primary TNM clinical staging | Rectal Carcinoma Primary TNM clinical staging | Operative Surgical Procedure Cure Histologic | Surgical Procedures, Laparoscopic

Data type

boolean

Alias
UMLS CUI [1,1]
C0699790
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C3258246
UMLS CUI [2,1]
C0007113
UMLS CUI [2,2]
C0205225
UMLS CUI [2,3]
C3258246
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C1880198
UMLS CUI [3,3]
C0205462
UMLS CUI [4]
C0751429
patients with primary tumor that directly invades other organs or structures and/or perforates into the visceral peritoneum (t4) or with histologically positive lymph node metastasis (n+) (to be judged after surgery)
Description

Primary tumor Visceral Peritoneum TNM clinical staging | Secondary malignant neoplasm of lymph node Histologic Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0230206
UMLS CUI [1,3]
C3258246
UMLS CUI [2,1]
C0686619
UMLS CUI [2,2]
C0205462
UMLS CUI [2,3]
C1514241
patients who is between 20 and 80 years old at the time of obtaining informed consent
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients with performance status of 0 - 2
Description

performance status

Data type

boolean

Alias
UMLS CUI [1]
C1518965
patients without receiving any cancer treatment such as radiation, chemotherapy, and immunotherapy before surgical operation
Description

cancer treatment Absent | Therapeutic radiology procedure | Chemotherapy | Immunotherapy | Operative Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0392920
UMLS CUI [4]
C0021083
UMLS CUI [5]
C0543467
patients without severe dysfunction of renal, hepatic, or bone marrow function
Description

Renal dysfunction Severe Absent | Liver Dysfunction Severe Absent | Bone Marrow Dysfunction Severe Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C3279454
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0086565
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0005953
UMLS CUI [3,2]
C3887504
UMLS CUI [3,3]
C0205082
UMLS CUI [3,4]
C0332197
patients without serious complications such as bone marrow suppression, diarrhea, and infections diseases
Description

Complication Serious Absent | Bone Marrow Suppression | Diarrhea | Communicable Diseases

Data type

boolean

Alias
UMLS CUI [1,1]
C0009566
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0332197
UMLS CUI [2]
C0280962
UMLS CUI [3]
C0011991
UMLS CUI [4]
C0009450
patients who have given consent to participate in this clinical study by himself/herself or his/her family
Description

Informed Consent | Informed Consent Family

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0015576
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients in whom the bottom of tumor reaches the peritoneal reflection
Description

Malignant Neoplasm Bottom Peritoneum

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C1511276
UMLS CUI [1,3]
C0031153
patients with lower rectal cancer (rb), anal canal (p), or circumanal skin (e)
Description

Rectal Carcinoma Lower | Malignant neoplasm of anal canal | Malignant Neoplasms Perianal skin

Data type

boolean

Alias
UMLS CUI [1,1]
C0007113
UMLS CUI [1,2]
C0441994
UMLS CUI [2]
C0153445
UMLS CUI [3,1]
C0006826
UMLS CUI [3,2]
C1704244
patients who has active multiple cancers or whose disease-free survival is less than 5 years even though the cancers are metachronous (except carcinoma in situ and skin cancers)
Description

Multiple malignancy | Life Expectancy Disease Free of | Malignant Neoplasms Timepoint Different | Carcinoma in Situ | Skin carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0346429
UMLS CUI [2,1]
C0023671
UMLS CUI [2,2]
C0012634
UMLS CUI [2,3]
C0332296
UMLS CUI [3,1]
C0006826
UMLS CUI [3,2]
C2348792
UMLS CUI [3,3]
C1705242
UMLS CUI [4]
C0007099
UMLS CUI [5]
C0699893
women who are currently pregnant or wish to be pregnant during this clinical study
Description

Pregnancy | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
patients who are judged to be inappropriate to participate in this clinical study by the investigator or subinvestigator
Description

Study Subject Participation Status Inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
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Similar models

Eligibility Colorectal Cancer NCT00385970

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Colon Carcinoma Primary TNM clinical staging | Rectal Carcinoma Primary TNM clinical staging | Operative Surgical Procedure Cure Histologic | Surgical Procedures, Laparoscopic
Item
patients with ptnm stage iib or iii (uicc sixth version) primary colon cancer/rectal cancer who have undergone surgery of histological curability a (including laparoscopic surgery) (the curability is judged after surgery)
boolean
C0699790 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C0007113 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
C3258246 (UMLS CUI [2,3])
C0543467 (UMLS CUI [3,1])
C1880198 (UMLS CUI [3,2])
C0205462 (UMLS CUI [3,3])
C0751429 (UMLS CUI [4])
Primary tumor Visceral Peritoneum TNM clinical staging | Secondary malignant neoplasm of lymph node Histologic Positive
Item
patients with primary tumor that directly invades other organs or structures and/or perforates into the visceral peritoneum (t4) or with histologically positive lymph node metastasis (n+) (to be judged after surgery)
boolean
C0677930 (UMLS CUI [1,1])
C0230206 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C0686619 (UMLS CUI [2,1])
C0205462 (UMLS CUI [2,2])
C1514241 (UMLS CUI [2,3])
Age
Item
patients who is between 20 and 80 years old at the time of obtaining informed consent
boolean
C0001779 (UMLS CUI [1])
performance status
Item
patients with performance status of 0 - 2
boolean
C1518965 (UMLS CUI [1])
cancer treatment Absent | Therapeutic radiology procedure | Chemotherapy | Immunotherapy | Operative Surgical Procedures
Item
patients without receiving any cancer treatment such as radiation, chemotherapy, and immunotherapy before surgical operation
boolean
C0920425 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C0021083 (UMLS CUI [4])
C0543467 (UMLS CUI [5])
Renal dysfunction Severe Absent | Liver Dysfunction Severe Absent | Bone Marrow Dysfunction Severe Absent
Item
patients without severe dysfunction of renal, hepatic, or bone marrow function
boolean
C3279454 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0086565 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0005953 (UMLS CUI [3,1])
C3887504 (UMLS CUI [3,2])
C0205082 (UMLS CUI [3,3])
C0332197 (UMLS CUI [3,4])
Complication Serious Absent | Bone Marrow Suppression | Diarrhea | Communicable Diseases
Item
patients without serious complications such as bone marrow suppression, diarrhea, and infections diseases
boolean
C0009566 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0280962 (UMLS CUI [2])
C0011991 (UMLS CUI [3])
C0009450 (UMLS CUI [4])
Informed Consent | Informed Consent Family
Item
patients who have given consent to participate in this clinical study by himself/herself or his/her family
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0015576 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasm Bottom Peritoneum
Item
patients in whom the bottom of tumor reaches the peritoneal reflection
boolean
C0006826 (UMLS CUI [1,1])
C1511276 (UMLS CUI [1,2])
C0031153 (UMLS CUI [1,3])
Rectal Carcinoma Lower | Malignant neoplasm of anal canal | Malignant Neoplasms Perianal skin
Item
patients with lower rectal cancer (rb), anal canal (p), or circumanal skin (e)
boolean
C0007113 (UMLS CUI [1,1])
C0441994 (UMLS CUI [1,2])
C0153445 (UMLS CUI [2])
C0006826 (UMLS CUI [3,1])
C1704244 (UMLS CUI [3,2])
Multiple malignancy | Life Expectancy Disease Free of | Malignant Neoplasms Timepoint Different | Carcinoma in Situ | Skin carcinoma
Item
patients who has active multiple cancers or whose disease-free survival is less than 5 years even though the cancers are metachronous (except carcinoma in situ and skin cancers)
boolean
C0346429 (UMLS CUI [1])
C0023671 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0332296 (UMLS CUI [2,3])
C0006826 (UMLS CUI [3,1])
C2348792 (UMLS CUI [3,2])
C1705242 (UMLS CUI [3,3])
C0007099 (UMLS CUI [4])
C0699893 (UMLS CUI [5])
Pregnancy | Pregnancy, Planned
Item
women who are currently pregnant or wish to be pregnant during this clinical study
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Study Subject Participation Status Inappropriate
Item
patients who are judged to be inappropriate to participate in this clinical study by the investigator or subinvestigator
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
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