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NCT00316914 · ClinicalTrials.gov registry record · Phase 3

Calcium Gluconate and Magnesium Sulfate 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

A Phase 3 study of Colorectal Cancer and Neurotoxicity, sponsored by Alliance for Clinical Trials in Oncology.

Completed
Registry status
Phase 3
Development phase
104
Enrollment target
14
Study locations

NCT00316914: Completed Phase 3 study of Colorectal Cancer and Neurotoxicity, sponsored by Alliance for Clinical Trials in Oncology.

NCT00316914 is a Phase 3 study of Colorectal Cancer and Neurotoxicity that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 104 participants, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (93% lower). The trial reports 14 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00316914, a Phase 3 study of Colorectal Cancer and Neurotoxicity, has completed, sponsored by Alliance for Clinical Trials in Oncology.

COMPLETED
Registry status
Phase 3
Development phase
104 participants
Enrollment target
14
Study locations

Study 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.

Primary Outcome

Neuropathic adverse events were assessed by Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Neurotoxicity evaluation grade: loss of deep tendon reflexes or paresthesia, including tingling, but not interfering with function (Grade 1); objective sensory alteration or paresthesia, including tingling, interfering with function, but not with activities of daily living (Grade 2); sensory alteration or paresthesia interfering with activities of daily living (Grade 3); permanent sensory los

Conditions Studied

Colorectal Cancer Neurotoxicity

Interventions

  • OTHER placebo
  • DRUG magnesium sulfate
  • DRUG calcium gluconate

Study Locations (14)

Iowa

  • Mercy Capitol Hospital - Des Moines
  • CCOP - Iowa Oncology Research Association - Des Moines
  • John Stoddard Cancer Center at Iowa Methodist Medical Center - Des Moines
  • Medical Oncology and Hematology Associates at John Stoddard Cancer Center - Des Moines
  • Medical Oncology and Hematology Associates at Mercy Cancer Center - Des Moines
  • Mercy Cancer Center at Mercy Medical Center - Des Moines - Des Moines
  • John Stoddard Cancer Center at Iowa Lutheran Hospital - Des Moines

North Dakota

  • Bismarck Cancer Center - Bismarck
  • Medcenter One Hospital Cancer Care Center - Bismarck
  • Mid Dakota Clinic, PC - Bismarck

South Dakota

  • Avera Cancer Institute - Sioux Falls
  • Medical X-Ray Center, PC - Sioux Falls
  • Sanford Cancer Center at Sanford USD Medical Center - Sioux Falls

Georgia

  • MBCCOP - Medical College of Georgia Cancer Center - Augusta

Trial Details

FieldValue
Enrollment Target 104 participants
Start Date 2006-01
Est. Completion 2012-11
Phase Phase 3
Alliance for Clinical Trials in Oncology

446 total trials

What the finished NCT00316914 record still lists

NCT00316914 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (93% lower).

The record links to 2 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 3 interventions - of which placebo is the first listed.

NCT00316914 lists 14 locations in 4 states (Iowa, North Dakota, South Dakota).

Frequently Asked Questions

What is clinical trial NCT00316914 about?

NCT00316914 is a clinical study titled "Calcium Gluconate and Magnesium Sulfate 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". 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 chem...

What is the current status of trial NCT00316914?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 104 participants. The study started on 2006-01. Estimated completion is 2012-11.

What conditions does trial NCT00316914 study?

This clinical trial studies the following conditions: Colorectal Cancer, Neurotoxicity.

What interventions are being tested in trial NCT00316914?

The interventions under investigation include: placebo (OTHER), magnesium sulfate (DRUG), calcium gluconate (DRUG).

Who is sponsoring clinical trial NCT00316914?

This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00316914 being conducted?

This trial has 14 study locations across Georgia, Iowa, North Dakota, South Dakota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Colorectal Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00316914's enrollment target sits among peer trials

104 213th of 381 higher than 169 of 381 other Colorectal Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Colorectal Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT00316914, the US trial registry maintained by the National Library of Medicine. NCT00316914 (mid enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.