CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 104 enrolled
Drug / intervention
calcium gluconate +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00316914
NCT00316914Phase 3Completed

A Phase III Randomized, Placebo-Controlled, Double-Blind Study of Intravenous Calcium/Magnesium to Prevent Oxaliplatin-Induced Sensory Neurotoxicity

Alliance for Clinical Trials in Oncology·interventional·Posted Apr 21, 2006·Updated Aug 11, 2016

In Brief

A Phase 3 clinical trial evaluating calcium gluconate, magnesium sulfate, and 1 other intervention for Colorectal Cancer and Neurotoxicity. Completed, enrolled 104 participants across 14 sites.

Detailed Summary

RATIONALE: Calcium gluconate and magnesium sulfate may prevent or lessen neurotoxicity caused by oxaliplatin. It is not yet known whether calcium gluconate and magnesium sulfate are more effective than a placebo in preventing neurotoxicity caused by oxaliplatin in patients receiving combination chemotherapy. PURPOSE: This randomized phase III trial is studying calcium gluconate and magnesium sulfate to see how well they work compared to a placebo in preventing neurotoxicity caused by oxaliplatin in patients receiving combination chemotherapy for stage II, stage III, or stage IV colorectal cancer that has been completely removed by surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 21, 2006
Enrollment StartJan 1, 2006
Primary CompletionJan 1, 2008
Study CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 20.2 years ago

Interventions

calcium gluconatedrug

Given IV

magnesium sulfatedrug

Given IV

placeboother

Given IV