ID

16814

Descrição

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

Palavras-chave

  1. 08/08/2016 08/08/2016 -
Transferido a

8 de agosto de 2016

DOI

Para um pedido faça login.

Licença

Creative Commons BY 4.0

Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Comentários do grupo de itens para :

Comentários do item para :


Sem comentários

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Eligibility Colorectal Neoplasms NCT00190515

Eligibility Colorectal Neoplasms NCT00190515

Inclusion Criteria
Descrição

Inclusion Criteria

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

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

Tipo de dados

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.
Descrição

Tumor site Cecum Rectum Upper | Tumor site Exclusion Rectum Lower

Tipo de dados

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(-).
Descrição

TNM clinical staging

Tipo de dados

boolean

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

Colorectal Carcinoma invasion into muscularis propria

Tipo de dados

boolean

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

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

Tipo de dados

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.
Descrição

Malignant Neoplasm Excision Cure Ability

Tipo de dados

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.
Descrição

Age

Tipo de dados

boolean

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

ECOG performance status

Tipo de dados

boolean

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

Prior Chemotherapy | prior radiation therapy

Tipo de dados

boolean

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

Normal diet Intake Ability | Able to swallow oral medication

Tipo de dados

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
Descrição

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

Tipo de dados

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.
Descrição

Adjuvant Chemotherapy Post Operative Surgical Procedures

Tipo de dados

boolean

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

Informed consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

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.
Descrição

Malignant Neoplasms | Disease Free of | Carcinoma in Situ

Tipo de dados

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.
Descrição

Postoperative Complications Severe Unresolved

Tipo de dados

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
Descrição

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

Tipo de dados

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.
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

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

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

Tipo de dados

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.
Descrição

Study Subject Participation Status Inappropriate

Tipo de dados

boolean

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

Similar models

Eligibility Colorectal Neoplasms NCT00190515

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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])

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial