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])
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])