ID

21837

Description

Evaluation of the Efficacy of Xaliproden (SR57746A) in Preventing the Neurotoxicity of Oxaliplatin / 5FU/LV Chemotherapy.; ODM derived from: https://clinicaltrials.gov/show/NCT00305188

Link

https://clinicaltrials.gov/show/NCT00305188

Keywords

Versions (1)
  1. 5/3/17 5/3/17 -
Uploaded on

May 3, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Metastases NCT00305188

English

Eligibility Metastases NCT00305188

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Metastases NCT00305188
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
main inclusion criteria :
Description

Inclusion criteria Main

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1542147
histologically or cytologically-proven metastatic cancer of the colon or rectum.
Description

Secondary malignant neoplasm of colon | Secondary malignant neoplasm of rectum

Data type

boolean

Alias
UMLS CUI [1]
C0346974
UMLS CUI [2]
C0346975
metastatic disease not amenable to potentially curative treatment (eg: inoperable metastatic disease).
Description

Neoplasm Metastasis Curative treatment Unsuccessful | Neoplasm Metastasis Inoperable

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1273390
UMLS CUI [1,3]
C1272705
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0205187
male or female aged >18 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
who performance status (ps) : 0 or 1.
Description

WHO performance status scale

Data type

boolean

Alias
UMLS CUI [1]
C1298650
measurable disease.
Description

Measurable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
no prior chemotherapeutic regimen for metastatic disease.
Description

Neoplasm Metastasis | Chemotherapy Regimen Absent

Data type

boolean

Alias
UMLS CUI [1]
C0027627
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0332197
disease-free interval from end of adjuvant therapy of at least 6 months (1 year if oxaliplatin was part of the adjuvant therapy).
Description

Adjuvant therapy | oxaliplatin | Interval Disease Free of

Data type

boolean

Alias
UMLS CUI [1]
C0677850
UMLS CUI [2]
C0069717
UMLS CUI [3,1]
C1272706
UMLS CUI [3,2]
C0012634
UMLS CUI [3,3]
C0332296
prior radiotherapy is permitted if it was not administered to target lesions identified for this study - unless progression within the radiation portal is documented - and provided it has been completed at least 3 weeks before randomization.
Description

Therapeutic radiology procedure Completed | Clinical Trial Target Lesion Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C2986546
UMLS CUI [2,3]
C2828389
signed written informed consent prior to study entry.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
main exclusion criteria :
Description

Exclusion Criteria Main

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
any condition or past medical history that contra-indicates treatment with oxaliplatin and 5-fu, as reported in approved labeling information.
Description

Medical contraindication Oxaliplatin | Medical contraindication 5-FU

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0069717
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0016360
received chemotherapeutic agents other than 5-fu, lv, levamisole, irinotecan, capecitabine, oxaliplatin as part of adjuvant therapy.
Description

Chemotherapeutic Agents | Fluorouracil | Leucovorin | Levamisole | irinotecan | capecitabine | oxaliplatin | Adjuvant therapy

Data type

boolean

Alias
UMLS CUI [1]
C0003392
UMLS CUI [2]
C0016360
UMLS CUI [3]
C0023413
UMLS CUI [4]
C0023556
UMLS CUI [5]
C0123931
UMLS CUI [6]
C0671970
UMLS CUI [7]
C0069717
UMLS CUI [8]
C0677850
peripheral neuropathy >grade 1.
Description

Peripheral Neuropathy CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
concomitant treatments with drugs/ingredients reported to have a potential activity in preventing peripheral sensory neuropathy.
Description

Pharmaceutical Preparations Preventing Peripheral sensory neuropathy | Pharmaceutical Preparation Ingredient Preventing Peripheral sensory neuropathy

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0151313
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C1550600
UMLS CUI [2,3]
C1292733
UMLS CUI [2,4]
C0151313
concurrent active cancer originating from a primary site other than colon or rectum.
Description

Malignant Neoplasm | Anatomic Site Colorectal Excluded

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1515974
UMLS CUI [2,2]
C0555952
UMLS CUI [2,3]
C2828389
presence of any symptom suggesting brain metastasis.
Description

Symptoms Metastatic malignant neoplasm to brain Suggestive of

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0220650
UMLS CUI [1,3]
C0332299
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Similar models

Eligibility Metastases NCT00305188

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Metastases NCT00305188
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Inclusion criteria Main
Item
main inclusion criteria :
boolean
C1512693 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Secondary malignant neoplasm of colon | Secondary malignant neoplasm of rectum
Item
histologically or cytologically-proven metastatic cancer of the colon or rectum.
boolean
C0346974 (UMLS CUI [1])
C0346975 (UMLS CUI [2])
Neoplasm Metastasis Curative treatment Unsuccessful | Neoplasm Metastasis Inoperable
Item
metastatic disease not amenable to potentially curative treatment (eg: inoperable metastatic disease).
boolean
C0027627 (UMLS CUI [1,1])
C1273390 (UMLS CUI [1,2])
C1272705 (UMLS CUI [1,3])
C0027627 (UMLS CUI [2,1])
C0205187 (UMLS CUI [2,2])
Age
Item
male or female aged >18 years.
boolean
C0001779 (UMLS CUI [1])
WHO performance status scale
Item
who performance status (ps) : 0 or 1.
boolean
C1298650 (UMLS CUI [1])
Measurable Disease
Item
measurable disease.
boolean
C1513041 (UMLS CUI [1])
Neoplasm Metastasis | Chemotherapy Regimen Absent
Item
no prior chemotherapeutic regimen for metastatic disease.
boolean
C0027627 (UMLS CUI [1])
C0392920 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Adjuvant therapy | oxaliplatin | Interval Disease Free of
Item
disease-free interval from end of adjuvant therapy of at least 6 months (1 year if oxaliplatin was part of the adjuvant therapy).
boolean
C0677850 (UMLS CUI [1])
C0069717 (UMLS CUI [2])
C1272706 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C0332296 (UMLS CUI [3,3])
Therapeutic radiology procedure Completed | Clinical Trial Target Lesion Excluded
Item
prior radiotherapy is permitted if it was not administered to target lesions identified for this study - unless progression within the radiation portal is documented - and provided it has been completed at least 3 weeks before randomization.
boolean
C1522449 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0008976 (UMLS CUI [2,1])
C2986546 (UMLS CUI [2,2])
C2828389 (UMLS CUI [2,3])
Informed Consent
Item
signed written informed consent prior to study entry.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria Main
Item
main exclusion criteria :
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Medical contraindication Oxaliplatin | Medical contraindication 5-FU
Item
any condition or past medical history that contra-indicates treatment with oxaliplatin and 5-fu, as reported in approved labeling information.
boolean
C1301624 (UMLS CUI [1,1])
C0069717 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0016360 (UMLS CUI [2,2])
Chemotherapeutic Agents | Fluorouracil | Leucovorin | Levamisole | irinotecan | capecitabine | oxaliplatin | Adjuvant therapy
Item
received chemotherapeutic agents other than 5-fu, lv, levamisole, irinotecan, capecitabine, oxaliplatin as part of adjuvant therapy.
boolean
C0003392 (UMLS CUI [1])
C0016360 (UMLS CUI [2])
C0023413 (UMLS CUI [3])
C0023556 (UMLS CUI [4])
C0123931 (UMLS CUI [5])
C0671970 (UMLS CUI [6])
C0069717 (UMLS CUI [7])
C0677850 (UMLS CUI [8])
Peripheral Neuropathy CTCAE Grades
Item
peripheral neuropathy >grade 1.
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Pharmaceutical Preparations Preventing Peripheral sensory neuropathy | Pharmaceutical Preparation Ingredient Preventing Peripheral sensory neuropathy
Item
concomitant treatments with drugs/ingredients reported to have a potential activity in preventing peripheral sensory neuropathy.
boolean
C0013227 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0151313 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C1550600 (UMLS CUI [2,2])
C1292733 (UMLS CUI [2,3])
C0151313 (UMLS CUI [2,4])
Malignant Neoplasm | Anatomic Site Colorectal Excluded
Item
concurrent active cancer originating from a primary site other than colon or rectum.
boolean
C0006826 (UMLS CUI [1])
C1515974 (UMLS CUI [2,1])
C0555952 (UMLS CUI [2,2])
C2828389 (UMLS CUI [2,3])
Symptoms Metastatic malignant neoplasm to brain Suggestive of
Item
presence of any symptom suggesting brain metastasis.
boolean
C1457887 (UMLS CUI [1,1])
C0220650 (UMLS CUI [1,2])
C0332299 (UMLS CUI [1,3])
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