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COMPLETED 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

NCT00316914 · View on ClinicalTrials.gov ↗

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.

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

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00316914

The ClinicalTrials.gov registry entry for NCT00316914 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 104 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alliance for Clinical Trials in Oncology, which has 147 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00316914 reports 14 study locations spanning 4 distinct geographic areas — top geographies include Iowa, North Dakota, South Dakota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00316914?

The interventions under investigation include: placebo (OTHER), magnesium sulfate (DRUG), calcium gluconate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00316914?

This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 147 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial