COLON ADENOCARCINOMA
Conditions
Interventions
Trade Name: SULFATO DE MAGNESIO LAVOISIER AL 15%
Pharmaceutical Form: Solution for injection
INN or Proposed INN: SULFATO DE MAGNESIO
Concentration unit: % percent
Concentration type: equal
Concentrat
Sponsors
ACROSS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically or citologically confirmed colon adenocarcinoma Colon adenocarcinoma full resected (surgery R0) subsidiary of adyuvance chemotherapy 18 years old Performance status less or equal to 2 Adequate organic function and stable medical condition Absence of basal peripheral neuropathy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Pregnant or lactating women or women of childbearing potential that do not use adequate contraception Previous colon or rectal cancer Prior malignancies, except curatively treated in situ carcinoma of the uterine cervix or esquamous/basal cells skin carcinoma with no evidence of disease for at least 10 years Participation in a clinical trial of one or more investigational agents within 30 days of study entry. Peripheral neuropathy NCIC-CTG major or equal to grade I Congestive heart disease, not controled angina, hypertension or arritmia History of significant neurologic or psychiatric disorders Active infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Neurologic Protection: To compare the seriously accumulated peripheral neurologic toxicity per patient induced by oxaliplatino (specific scale grade 1-4) between arm A: Standar chemotherapy based on oxaliplatino plus placebo versus arm B: Standard chemotherapy based on Oxaliplatino plus Ca/Mg. ;Secondary Objective: Neurologic toxicity Antitumoral efficacy Safety;Primary end point(s): Accumulated peripheral neurologic toxicity induced by oxaliplatino | — |
Countries
Spain
Outcome results
None listed