ID

16814

Description

A Trial Comparing Adjuvant Oral UFT/LV to 5-FU/l-LV in Stage III Colorectal Cancer (JCOG-0205-MF); ODM derived from: https://clinicaltrials.gov/show/NCT00190515

Link

https://clinicaltrials.gov/show/NCT00190515

Keywords

Versions (1)
  1. 8/8/16 8/8/16 -
Uploaded on

August 8, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Colorectal Neoplasms NCT00190515

English

Eligibility Colorectal Neoplasms NCT00190515

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. pathologically proved colorectal cancer (either adenocarcinoma, mucinous carcinoma, or signet-ring cell carcinoma).
Description

Colorectal Carcinoma | Adenocarcinoma | Carcinoma Mucinous | Carcinoma, Signet Ring Cell

Data type

boolean

Alias
UMLS CUI [1]
C0009402
UMLS CUI [2]
C0001418
UMLS CUI [3,1]
C0007097
UMLS CUI [3,2]
C1513712
UMLS CUI [4]
C0206696
2. tumor is mainly located in between cecum and upper rectum, excluding that invades to lower rectum.
Description

Tumor site Cecum Rectum Upper | Tumor site Exclusion Rectum Lower

Data type

boolean

Alias
UMLS CUI [1,1]
C0475445
UMLS CUI [1,2]
C0007531
UMLS CUI [1,3]
C0034896
UMLS CUI [1,4]
C1282910
UMLS CUI [2,1]
C0475445
UMLS CUI [2,2]
C2828389
UMLS CUI [2,3]
C0034896
UMLS CUI [2,4]
C0441994
3. stage iii cancer by general rules for clinical and pathological studies on cancer of the colon, rectum and anus (6th ed.), excluding si(ai), n(-), m(-).
Description

TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1]
C3258246
4. no synchronous colorectal cancer which invade muscularis propria or deeper.
Description

Colorectal Carcinoma invasion into muscularis propria

Data type

boolean

Alias
UMLS CUI [1,1]
C0009402
UMLS CUI [1,2]
C1272778
5. tumor resection with d2 or d3 lymph node dissection was performed.
Description

Malignant Neoplasm Excision | D2 lymph node dissection | D3 lymph node dissection

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0728940
UMLS CUI [2]
C2960517
UMLS CUI [3]
C2960226
6. pathological determination of curability of tumor resection is cur a.
Description

Malignant Neoplasm Excision Cure Ability

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0728940
UMLS CUI [1,3]
C1880198
UMLS CUI [1,4]
C0085732
7. age at registration is above 20 and below 75 years old.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
8. ecog performance status is 0 or 1.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
9. no prior chemotherapy or radiation therapy.
Description

Prior Chemotherapy | prior radiation therapy

Data type

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2]
C0279134
10. intake of normal diet and oral drugs is possible.
Description

Normal diet Intake Ability | Able to swallow oral medication

Data type

boolean

Alias
UMLS CUI [1,1]
C0184625
UMLS CUI [1,2]
C1512806
UMLS CUI [1,3]
C0085732
UMLS CUI [2,1]
C2712086
UMLS CUI [2,2]
C0175795
11. major organ function is preserved. wbc>=3,000/mcl, plt>=100,000/mcl, got<=100 iu/l, gpt<=100 iu/l, t.bil <=2.0 mg/dl, cr<=1.5 mg/dl
Description

Organ Major function | White Blood Cell Count procedure | Platelet Count measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Bilirubin, total measurement | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1,1]
C0178784
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C0031843
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0201899
UMLS CUI [5]
C0201836
UMLS CUI [6]
C0201913
UMLS CUI [7]
C0201976
12. adjuvant chemotherapy can be started within 9 weeks after surgery.
Description

Adjuvant Chemotherapy Post Operative Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C0085533
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0543467
13. written informed consent is taken.
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. active co-existing malignancy （synchronous or metachronous malignancy whose disease free period is within 5 years). carcinoma in situ is eligible.
Description

Malignant Neoplasms | Disease Free of | Carcinoma in Situ

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0332296
UMLS CUI [3]
C0007099
2. severe postoperative complications which do not resolve until registration.
Description

Postoperative Complications Severe Unresolved

Data type

boolean

Alias
UMLS CUI [1,1]
C0032787
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0443342
3. there is following complication. insulin-controlling or uncontrollable diabetes mellitus, uncontrollable hypertension, myocardial infarction within six month or unstable angina pectoris, liver cirrhosis, interstitial pneumonia, pulmonary fibrosis, severe emphysema
Description

Complication | Insulin Controlling | DIABETES MELLITUS UNCONTROLLED | Uncontrolled hypertension | Myocardial Infarction | Angina, Unstable | Liver Cirrhosis | Pneumonia, Interstitial | Pulmonary Fibrosis | Pulmonary Emphysema Severe

Data type

boolean

Alias
UMLS CUI [1]
C0009566
UMLS CUI [2,1]
C0021641
UMLS CUI [2,2]
C2239193
UMLS CUI [3]
C0743131
UMLS CUI [4]
C1868885
UMLS CUI [5]
C0027051
UMLS CUI [6]
C0002965
UMLS CUI [7]
C0023890
UMLS CUI [8]
C0206061
UMLS CUI [9]
C0034069
UMLS CUI [10,1]
C0034067
UMLS CUI [10,2]
C0205082
4. pregnant or breast-feeding woman.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
5. difficult to participate with the trial, having mental disorder or psychiatric symptoms.
Description

Mental disorders Study Subject Participation Status Limited | Psychiatric symptom Study Subject Participation Status Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0439801
UMLS CUI [2,1]
C0233401
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C0439801
6. judged to be inappropriate to register.
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 Neoplasms NCT00190515

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Colorectal Carcinoma | Adenocarcinoma | Carcinoma Mucinous | Carcinoma, Signet Ring Cell
Item
1. pathologically proved colorectal cancer (either adenocarcinoma, mucinous carcinoma, or signet-ring cell carcinoma).
boolean
C0009402 (UMLS CUI [1])
C0001418 (UMLS CUI [2])
C0007097 (UMLS CUI [3,1])
C1513712 (UMLS CUI [3,2])
C0206696 (UMLS CUI [4])
Tumor site Cecum Rectum Upper | Tumor site Exclusion Rectum Lower
Item
2. tumor is mainly located in between cecum and upper rectum, excluding that invades to lower rectum.
boolean
C0475445 (UMLS CUI [1,1])
C0007531 (UMLS CUI [1,2])
C0034896 (UMLS CUI [1,3])
C1282910 (UMLS CUI [1,4])
C0475445 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
C0034896 (UMLS CUI [2,3])
C0441994 (UMLS CUI [2,4])
TNM clinical staging
Item
3. stage iii cancer by general rules for clinical and pathological studies on cancer of the colon, rectum and anus (6th ed.), excluding si(ai), n(-), m(-).
boolean
C3258246 (UMLS CUI [1])
Colorectal Carcinoma invasion into muscularis propria
Item
4. no synchronous colorectal cancer which invade muscularis propria or deeper.
boolean
C0009402 (UMLS CUI [1,1])
C1272778 (UMLS CUI [1,2])
Malignant Neoplasm Excision | D2 lymph node dissection | D3 lymph node dissection
Item
5. tumor resection with d2 or d3 lymph node dissection was performed.
boolean
C0006826 (UMLS CUI [1,1])
C0728940 (UMLS CUI [1,2])
C2960517 (UMLS CUI [2])
C2960226 (UMLS CUI [3])
Malignant Neoplasm Excision Cure Ability
Item
6. pathological determination of curability of tumor resection is cur a.
boolean
C0006826 (UMLS CUI [1,1])
C0728940 (UMLS CUI [1,2])
C1880198 (UMLS CUI [1,3])
C0085732 (UMLS CUI [1,4])
Age
Item
7. age at registration is above 20 and below 75 years old.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
8. ecog performance status is 0 or 1.
boolean
C1520224 (UMLS CUI [1])
Prior Chemotherapy | prior radiation therapy
Item
9. no prior chemotherapy or radiation therapy.
boolean
C1514457 (UMLS CUI [1])
C0279134 (UMLS CUI [2])
Normal diet Intake Ability | Able to swallow oral medication
Item
10. intake of normal diet and oral drugs is possible.
boolean
C0184625 (UMLS CUI [1,1])
C1512806 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C2712086 (UMLS CUI [2,1])
C0175795 (UMLS CUI [2,2])
Organ Major function | White Blood Cell Count procedure | Platelet Count measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Bilirubin, total measurement | Creatinine measurement, serum
Item
11. major organ function is preserved. wbc>=3,000/mcl, plt>=100,000/mcl, got<=100 iu/l, gpt<=100 iu/l, t.bil <=2.0 mg/dl, cr<=1.5 mg/dl
boolean
C0178784 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0031843 (UMLS CUI [1,3])
C0023508 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
C0201913 (UMLS CUI [6])
C0201976 (UMLS CUI [7])
Adjuvant Chemotherapy Post Operative Surgical Procedures
Item
12. adjuvant chemotherapy can be started within 9 weeks after surgery.
boolean
C0085533 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
Informed consent
Item
13. written informed consent is taken.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasms | Disease Free of | Carcinoma in Situ
Item
1. active co-existing malignancy （synchronous or metachronous malignancy whose disease free period is within 5 years). carcinoma in situ is eligible.
boolean
C0006826 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0332296 (UMLS CUI [2,2])
C0007099 (UMLS CUI [3])
Postoperative Complications Severe Unresolved
Item
2. severe postoperative complications which do not resolve until registration.
boolean
C0032787 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0443342 (UMLS CUI [1,3])
Complication | Insulin Controlling | DIABETES MELLITUS UNCONTROLLED | Uncontrolled hypertension | Myocardial Infarction | Angina, Unstable | Liver Cirrhosis | Pneumonia, Interstitial | Pulmonary Fibrosis | Pulmonary Emphysema Severe
Item
3. there is following complication. insulin-controlling or uncontrollable diabetes mellitus, uncontrollable hypertension, myocardial infarction within six month or unstable angina pectoris, liver cirrhosis, interstitial pneumonia, pulmonary fibrosis, severe emphysema
boolean
C0009566 (UMLS CUI [1])
C0021641 (UMLS CUI [2,1])
C2239193 (UMLS CUI [2,2])
C0743131 (UMLS CUI [3])
C1868885 (UMLS CUI [4])
C0027051 (UMLS CUI [5])
C0002965 (UMLS CUI [6])
C0023890 (UMLS CUI [7])
C0206061 (UMLS CUI [8])
C0034069 (UMLS CUI [9])
C0034067 (UMLS CUI [10,1])
C0205082 (UMLS CUI [10,2])
Pregnancy | Breast Feeding
Item
4. pregnant or breast-feeding woman.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Mental disorders Study Subject Participation Status Limited | Psychiatric symptom Study Subject Participation Status Limited
Item
5. difficult to participate with the trial, having mental disorder or psychiatric symptoms.
boolean
C0004936 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0233401 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
Study Subject Participation Status Inappropriate
Item
6. judged to be inappropriate to register.
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
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