ID

16768

Description

A Randomized Trial of Avastin + Gemcitabine + 5-Fluorouracil (5FU)/Folinic Acid Versus Avastin + Oxaliplatin + 5FU/Folinic Acid in Metastatic Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00192075

Link

https://clinicaltrials.gov/show/NCT00192075

Keywords

Versions (1)
  1. 8/5/16 8/5/16 -
Uploaded on

August 5, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT00192075

English

Eligibility Colorectal Cancer NCT00192075

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have a histological or cytological diagnosis of the colon or rectum with stage iii unresectable or stage iv disease.
Description

Colon Carcinoma | Rectal Carcinoma | TNM clinical staging | Colon Carcinoma unresectable | Rectal Carcinoma unresectable

Data type

boolean

Alias
UMLS CUI [1]
C0699790
UMLS CUI [2]
C0007113
UMLS CUI [3]
C3258246
UMLS CUI [4,1]
C0699790
UMLS CUI [4,2]
C1519810
UMLS CUI [5,1]
C0007113
UMLS CUI [5,2]
C1519810
urinalysis or urine dipstick for proteinuria of less than 1+ (i.e. either 0 or trace). if urine dipstick is greater than 1+, the 24 hour urine protein must demonstrate less than 500 mg of protein in 24 hours to allow participation.
Description

Urinalysis Proteinuria | Urine dipstick test Proteinuria | Urine protein test

Data type

boolean

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0033687
UMLS CUI [2,1]
C0430370
UMLS CUI [2,2]
C0033687
UMLS CUI [3]
C0262923
no prior chemotherapy, immunotherapy, or hormonal treatment for metastatic disease is acceptable. however, one prior neo-adjuvant or adjuvant treatment is acceptable, including capecitabine, camptothecin-11 (cpt-11), 5 fluorouracil/leucovorin (5fu/lv) or radiation containing regimens, (but no oxaliplatin), and only if progression > 6 months since last adjuvant treatment.
Description

Prior Chemotherapy Neoplasm Metastasis | Prior Immunotherapy Neoplasm Metastasis | Prior Hormone Therapy Neoplasm Metastasis | Adjuvant therapy | Neoadjuvant Therapy | capecitabine | Irinotecan hydrochloride | Fluorouracil | Leucovorin | Therapeutic radiology procedure | oxaliplatin | Disease Progression

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0027627
UMLS CUI [2,1]
C1514461
UMLS CUI [2,2]
C0027627
UMLS CUI [3,1]
C1514460
UMLS CUI [3,2]
C0027627
UMLS CUI [4]
C0677850
UMLS CUI [5]
C0600558
UMLS CUI [6]
C0671970
UMLS CUI [7]
C0594375
UMLS CUI [8]
C0016360
UMLS CUI [9]
C0023413
UMLS CUI [10]
C1522449
UMLS CUI [11]
C0069717
UMLS CUI [12]
C0242656
prior radiation therapy, including radiation to the whole pelvis, is allowed (cristy and eckerman 1987) and patients must have recovered from the acute toxic effects of the treatment prior to study enrollment. prior palliative radiation therapy given to a non-measurable diagnostic site is acceptable if given > 4 weeks prior to treatment or if other non-irradiated measurable disease is present.
Description

prior radiation therapy | pelvis radiation | Toxic effect Due to Prior Therapy | Patient recovered | Palliative Radiation Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0279134
UMLS CUI [2]
C0747411
UMLS CUI [3,1]
C0600688
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C1514463
UMLS CUI [4]
C1115804
UMLS CUI [5]
C3898008
no known central nervous system (cns) metastasis.
Description

CNS metastases

Data type

boolean

Alias
UMLS CUI [1]
C0686377
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
histology other than adenocarcinoma
Description

Histology | Adenocarcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0344441
UMLS CUI [2]
C0001418
tumors that demonstrate free perforation as manifested by free air or free fluid in the abdomen. patients with walled-off perforation are eligible.
Description

Malignant Neoplasms Perforation Free | Free air in abdomen | Perforation Walled off cavity

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0549099
UMLS CUI [1,3]
C1996904
UMLS CUI [2]
C0032320
UMLS CUI [3,1]
C0549099
UMLS CUI [3,2]
C1265821
gastroduodenal ulcer determined as active by endoscopy.
Description

Peptic Ulcer | Endoscopy

Data type

boolean

Alias
UMLS CUI [1]
C0030920
UMLS CUI [2]
C0014245
invasive procedures defined as follows; major surgical procedures, open biopsy, or significant traumatic injury within 28 days prior to randomization, anticipation of need for major surgical procedure during the course of study, core biopsy or other minor procedure within 7 days prior to registration.
Description

Invasive procedure | major surgery | Incisional biopsy | Traumatic injury Significant | major surgery needed Anticipated | Core biopsy | Minor Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1]
C4048276
UMLS CUI [2]
C0679637
UMLS CUI [3]
C0184922
UMLS CUI [4,1]
C3263723
UMLS CUI [4,2]
C0750502
UMLS CUI [5,1]
C0679637
UMLS CUI [5,2]
C0686904
UMLS CUI [5,3]
C3840775
UMLS CUI [6]
C1318309
UMLS CUI [7]
C0038904
following cardiac condition; new york heart association (nyha) class iii or iv, myocardial infarction (mi) within 6 months, unstable angina within 6 months and current symptomatic arrhythmia.
Description

Heart Diseases Status post | New York Heart Association Classification | Myocardial Infarction | Angina, Unstable | ARRHYTHMIA SYMPTOMATIC

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0231290
UMLS CUI [2]
C1275491
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0741212
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Similar models

Eligibility Colorectal Cancer NCT00192075

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Colon Carcinoma | Rectal Carcinoma | TNM clinical staging | Colon Carcinoma unresectable | Rectal Carcinoma unresectable
Item
patients must have a histological or cytological diagnosis of the colon or rectum with stage iii unresectable or stage iv disease.
boolean
C0699790 (UMLS CUI [1])
C0007113 (UMLS CUI [2])
C3258246 (UMLS CUI [3])
C0699790 (UMLS CUI [4,1])
C1519810 (UMLS CUI [4,2])
C0007113 (UMLS CUI [5,1])
C1519810 (UMLS CUI [5,2])
Urinalysis Proteinuria | Urine dipstick test Proteinuria | Urine protein test
Item
urinalysis or urine dipstick for proteinuria of less than 1+ (i.e. either 0 or trace). if urine dipstick is greater than 1+, the 24 hour urine protein must demonstrate less than 500 mg of protein in 24 hours to allow participation.
boolean
C0042014 (UMLS CUI [1,1])
C0033687 (UMLS CUI [1,2])
C0430370 (UMLS CUI [2,1])
C0033687 (UMLS CUI [2,2])
C0262923 (UMLS CUI [3])
Prior Chemotherapy Neoplasm Metastasis | Prior Immunotherapy Neoplasm Metastasis | Prior Hormone Therapy Neoplasm Metastasis | Adjuvant therapy | Neoadjuvant Therapy | capecitabine | Irinotecan hydrochloride | Fluorouracil | Leucovorin | Therapeutic radiology procedure | oxaliplatin | Disease Progression
Item
no prior chemotherapy, immunotherapy, or hormonal treatment for metastatic disease is acceptable. however, one prior neo-adjuvant or adjuvant treatment is acceptable, including capecitabine, camptothecin-11 (cpt-11), 5 fluorouracil/leucovorin (5fu/lv) or radiation containing regimens, (but no oxaliplatin), and only if progression > 6 months since last adjuvant treatment.
boolean
C1514457 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C1514461 (UMLS CUI [2,1])
C0027627 (UMLS CUI [2,2])
C1514460 (UMLS CUI [3,1])
C0027627 (UMLS CUI [3,2])
C0677850 (UMLS CUI [4])
C0600558 (UMLS CUI [5])
C0671970 (UMLS CUI [6])
C0594375 (UMLS CUI [7])
C0016360 (UMLS CUI [8])
C0023413 (UMLS CUI [9])
C1522449 (UMLS CUI [10])
C0069717 (UMLS CUI [11])
C0242656 (UMLS CUI [12])
prior radiation therapy | pelvis radiation | Toxic effect Due to Prior Therapy | Patient recovered | Palliative Radiation Therapy
Item
prior radiation therapy, including radiation to the whole pelvis, is allowed (cristy and eckerman 1987) and patients must have recovered from the acute toxic effects of the treatment prior to study enrollment. prior palliative radiation therapy given to a non-measurable diagnostic site is acceptable if given > 4 weeks prior to treatment or if other non-irradiated measurable disease is present.
boolean
C0279134 (UMLS CUI [1])
C0747411 (UMLS CUI [2])
C0600688 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C1514463 (UMLS CUI [3,3])
C1115804 (UMLS CUI [4])
C3898008 (UMLS CUI [5])
CNS metastases
Item
no known central nervous system (cns) metastasis.
boolean
C0686377 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Histology | Adenocarcinoma
Item
histology other than adenocarcinoma
boolean
C0344441 (UMLS CUI [1])
C0001418 (UMLS CUI [2])
Malignant Neoplasms Perforation Free | Free air in abdomen | Perforation Walled off cavity
Item
tumors that demonstrate free perforation as manifested by free air or free fluid in the abdomen. patients with walled-off perforation are eligible.
boolean
C0006826 (UMLS CUI [1,1])
C0549099 (UMLS CUI [1,2])
C1996904 (UMLS CUI [1,3])
C0032320 (UMLS CUI [2])
C0549099 (UMLS CUI [3,1])
C1265821 (UMLS CUI [3,2])
Peptic Ulcer | Endoscopy
Item
gastroduodenal ulcer determined as active by endoscopy.
boolean
C0030920 (UMLS CUI [1])
C0014245 (UMLS CUI [2])
Invasive procedure | major surgery | Incisional biopsy | Traumatic injury Significant | major surgery needed Anticipated | Core biopsy | Minor Surgical Procedures
Item
invasive procedures defined as follows; major surgical procedures, open biopsy, or significant traumatic injury within 28 days prior to randomization, anticipation of need for major surgical procedure during the course of study, core biopsy or other minor procedure within 7 days prior to registration.
boolean
C4048276 (UMLS CUI [1])
C0679637 (UMLS CUI [2])
C0184922 (UMLS CUI [3])
C3263723 (UMLS CUI [4,1])
C0750502 (UMLS CUI [4,2])
C0679637 (UMLS CUI [5,1])
C0686904 (UMLS CUI [5,2])
C3840775 (UMLS CUI [5,3])
C1318309 (UMLS CUI [6])
C0038904 (UMLS CUI [7])
Heart Diseases Status post | New York Heart Association Classification | Myocardial Infarction | Angina, Unstable | ARRHYTHMIA SYMPTOMATIC
Item
following cardiac condition; new york heart association (nyha) class iii or iv, myocardial infarction (mi) within 6 months, unstable angina within 6 months and current symptomatic arrhythmia.
boolean
C0018799 (UMLS CUI [1,1])
C0231290 (UMLS CUI [1,2])
C1275491 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0741212 (UMLS CUI [5])
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