ID

16803

Beschrijving

Trial Of Irinotecan In Combination With Three Methods Of Administration Of Fluoropyrimidine.; ODM derived from: https://clinicaltrials.gov/show/NCT00101686

Link

https://clinicaltrials.gov/show/NCT00101686

Trefwoorden

Versies (1)
  1. 08-08-16 08-08-16 -
Geüploaded op

8 augustus 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Colorectal Neoplasms NCT00101686

Engels

Eligibility Colorectal Neoplasms NCT00101686

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of colorectal cancer (either newly diagnosed or recurrent disease) with evidence of metastatic disease. (stage iv distant disease)
Beschrijving

Colorectal Carcinoma | Recurrent disease | Neoplasm Metastasis Evidence of | TNM clinical staging

Datatype

boolean

Alias
UMLS CUI [1]
C0009402
UMLS CUI [2]
C0277556
UMLS CUI [3,1]
C0027627
UMLS CUI [3,2]
C0332120
UMLS CUI [4]
C3258246
present or past histological documentation of adenocarcinoma of the colon or rectum. the site of the primary lesion must be or have been confirmed endoscopically, radiologically, or surgically to be or have been in the large bowel. patients with a history of colorectal cancer treated by surgical resection who develop radiological or clinical evidence of metastatic cancer do not require separate histological or cytological confirmation of metastatic disease unless:
Beschrijving

Adenocarcinoma of colon | Adenocarcinoma of rectum | Site of primary lesion Large Intestine | Endoscopy | Diagnostic radiologic examination | Diagnostic Techniques, Surgical | Colorectal Carcinoma Excision | Neoplasm Metastasis Evidence of

Datatype

boolean

Alias
UMLS CUI [1]
C0338106
UMLS CUI [2]
C0149978
UMLS CUI [3,1]
C0449695
UMLS CUI [3,2]
C0021851
UMLS CUI [4]
C0014245
UMLS CUI [5]
C0043299
UMLS CUI [6]
C0011918
UMLS CUI [7,1]
C0009402
UMLS CUI [7,2]
C0728940
UMLS CUI [8,1]
C0027627
UMLS CUI [8,2]
C0332120
an interval of greater than five years has elapsed between the primary surgery and the development of metastatic disease.
Beschrijving

Operative Surgical Procedures Primary | Neoplasm Metastasis | Interval Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0205225
UMLS CUI [2]
C0027627
UMLS CUI [3,1]
C1272706
UMLS CUI [3,2]
C1265611
the primary cancer was a duke's a or b1.
Beschrijving

primary tumor Dukes stage

Datatype

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C1272820
physicians should consider biopsy of lesions to establish the diagnosis of metastatic colorectal cancer in each case if there is substantial clinical ambiguity regarding the nature of source of apparent metastases.
Beschrijving

Colorectal cancer metastatic | biopsied lesion

Datatype

boolean

Alias
UMLS CUI [1]
C0948380
UMLS CUI [2]
C0940828
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who received any prior systemic anticancer therapy for metastatic colorectal cancer (e.g., chemotherapy, antibody therapy, immunotherapy, gene therapy, vaccine therapy, cytokine therapy, or other experimental agents).
Beschrijving

cancer treatment Systemic Colorectal cancer metastatic | Chemotherapy | antibody therapy | Immunotherapy | gene therapy | Vaccine Therapy | Cytokine therapy | Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C0948380
UMLS CUI [2]
C0392920
UMLS CUI [3]
C0281176
UMLS CUI [4]
C0021083
UMLS CUI [5]
C0017296
UMLS CUI [6]
C0042209
UMLS CUI [7]
C0199974
UMLS CUI [8]
C0013230
patients cannot have concurrent malignancies at study entry.
Beschrijving

Malignant Neoplasms

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
exceptions: patients with prior non-colorectal malignancies will be eligible if they have been disease-free for ³ 3 years or are deemed at low risk for recurrence by their treating physician (e.g., early stage prostate cancer, melanoma or bladder cancer). patients with squamous or basal cell carcinoma of the skin or in situ cervical cancer that have been effectively treated are eligible, even if these were diagnosed within 3 years before randomization.
Beschrijving

Malignant Neoplasms | Disease Free Quantity | Disease recurrence Low Risk | Prostate carcinoma Limited stage | melanoma Limited stage | Carcinoma of bladder Limited stage | Squamous cell carcinoma of skin Treated Effective | Basal cell carcinoma Treated Effective | Carcinoma in situ of uterine cervix Treated Effective

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0332296
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C0679254
UMLS CUI [3,2]
C3538919
UMLS CUI [4,1]
C0600139
UMLS CUI [4,2]
C1517886
UMLS CUI [5,1]
C0025202
UMLS CUI [5,2]
C1517886
UMLS CUI [6,1]
C0699885
UMLS CUI [6,2]
C1517886
UMLS CUI [7,1]
C0553723
UMLS CUI [7,2]
C1522326
UMLS CUI [7,3]
C1280519
UMLS CUI [8,1]
C0007117
UMLS CUI [8,2]
C1522326
UMLS CUI [8,3]
C1280519
UMLS CUI [9,1]
C0851140
UMLS CUI [9,2]
C1522326
UMLS CUI [9,3]
C1280519
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Eligibility Colorectal Neoplasms NCT00101686

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Colorectal Carcinoma | Recurrent disease | Neoplasm Metastasis Evidence of | TNM clinical staging
Item
diagnosis of colorectal cancer (either newly diagnosed or recurrent disease) with evidence of metastatic disease. (stage iv distant disease)
boolean
C0009402 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
C0027627 (UMLS CUI [3,1])
C0332120 (UMLS CUI [3,2])
C3258246 (UMLS CUI [4])
Adenocarcinoma of colon | Adenocarcinoma of rectum | Site of primary lesion Large Intestine | Endoscopy | Diagnostic radiologic examination | Diagnostic Techniques, Surgical | Colorectal Carcinoma Excision | Neoplasm Metastasis Evidence of
Item
present or past histological documentation of adenocarcinoma of the colon or rectum. the site of the primary lesion must be or have been confirmed endoscopically, radiologically, or surgically to be or have been in the large bowel. patients with a history of colorectal cancer treated by surgical resection who develop radiological or clinical evidence of metastatic cancer do not require separate histological or cytological confirmation of metastatic disease unless:
boolean
C0338106 (UMLS CUI [1])
C0149978 (UMLS CUI [2])
C0449695 (UMLS CUI [3,1])
C0021851 (UMLS CUI [3,2])
C0014245 (UMLS CUI [4])
C0043299 (UMLS CUI [5])
C0011918 (UMLS CUI [6])
C0009402 (UMLS CUI [7,1])
C0728940 (UMLS CUI [7,2])
C0027627 (UMLS CUI [8,1])
C0332120 (UMLS CUI [8,2])
Operative Surgical Procedures Primary | Neoplasm Metastasis | Interval Quantity
Item
an interval of greater than five years has elapsed between the primary surgery and the development of metastatic disease.
boolean
C0543467 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2])
C1272706 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
primary tumor Dukes stage
Item
the primary cancer was a duke's a or b1.
boolean
C0677930 (UMLS CUI [1,1])
C1272820 (UMLS CUI [1,2])
Colorectal cancer metastatic | biopsied lesion
Item
physicians should consider biopsy of lesions to establish the diagnosis of metastatic colorectal cancer in each case if there is substantial clinical ambiguity regarding the nature of source of apparent metastases.
boolean
C0948380 (UMLS CUI [1])
C0940828 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
cancer treatment Systemic Colorectal cancer metastatic | Chemotherapy | antibody therapy | Immunotherapy | gene therapy | Vaccine Therapy | Cytokine therapy | Investigational New Drugs
Item
patients who received any prior systemic anticancer therapy for metastatic colorectal cancer (e.g., chemotherapy, antibody therapy, immunotherapy, gene therapy, vaccine therapy, cytokine therapy, or other experimental agents).
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0948380 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2])
C0281176 (UMLS CUI [3])
C0021083 (UMLS CUI [4])
C0017296 (UMLS CUI [5])
C0042209 (UMLS CUI [6])
C0199974 (UMLS CUI [7])
C0013230 (UMLS CUI [8])
Malignant Neoplasms
Item
patients cannot have concurrent malignancies at study entry.
boolean
C0006826 (UMLS CUI [1])
Malignant Neoplasms | Disease Free Quantity | Disease recurrence Low Risk | Prostate carcinoma Limited stage | melanoma Limited stage | Carcinoma of bladder Limited stage | Squamous cell carcinoma of skin Treated Effective | Basal cell carcinoma Treated Effective | Carcinoma in situ of uterine cervix Treated Effective
Item
exceptions: patients with prior non-colorectal malignancies will be eligible if they have been disease-free for ³ 3 years or are deemed at low risk for recurrence by their treating physician (e.g., early stage prostate cancer, melanoma or bladder cancer). patients with squamous or basal cell carcinoma of the skin or in situ cervical cancer that have been effectively treated are eligible, even if these were diagnosed within 3 years before randomization.
boolean
C0006826 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0332296 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0679254 (UMLS CUI [3,1])
C3538919 (UMLS CUI [3,2])
C0600139 (UMLS CUI [4,1])
C1517886 (UMLS CUI [4,2])
C0025202 (UMLS CUI [5,1])
C1517886 (UMLS CUI [5,2])
C0699885 (UMLS CUI [6,1])
C1517886 (UMLS CUI [6,2])
C0553723 (UMLS CUI [7,1])
C1522326 (UMLS CUI [7,2])
C1280519 (UMLS CUI [7,3])
C0007117 (UMLS CUI [8,1])
C1522326 (UMLS CUI [8,2])
C1280519 (UMLS CUI [8,3])
C0851140 (UMLS CUI [9,1])
C1522326 (UMLS CUI [9,2])
C1280519 (UMLS CUI [9,3])
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