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NCT01099449 · ClinicalTrials.gov registry record · Phase 3

Calcium Gluconate and Magnesium Sulfate in Preventing Neurotoxicity in Patients With Colon Cancer or Rectal Cancer Receiving Oxaliplatin-Based Combination Chemotherapy

A Phase 3 study, sponsored by Alliance for Clinical Trials in Oncology.

Completed
Registry status
Phase 3
Development phase
362
Enrollment target

NCT01099449 is a Phase 3 study that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 362 participants.

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The verdict

NCT01099449, a Phase 3 study, has completed, sponsored by Alliance for Clinical Trials in Oncology.

COMPLETED
Registry status
Phase 3
Development phase
362 participants
Enrollment target

Study Summary

RATIONALE: Chemoprotective drugs, such as calcium gluconate and magnesium sulfate, may prevent neurotoxicity caused by oxaliplatin. It is not yet known which administration schedule of calcium gluconate and magnesium sulfate is more effective in preventing neurotoxicity. PURPOSE: This randomized phase III trial is studying different administration schedules of calcium gluconate and magnesium sulfate and comparing how well they work in neurotoxicity in patients with colon cancer or rectal cancer receiving oxaliplatin-based combination chemotherapy.

Interventions

  • OTHER placebo
  • DRUG oxaliplatin
  • DRUG magnesium sulfate
  • DRUG calcium gluconate

Trial Details

FieldValue
Enrollment Target 362 participants
Start Date 2010-06
Est. Completion 2013-03
Phase Phase 3

What the Registry Record Tells You About NCT01099449

The ClinicalTrials.gov registry entry for NCT01099449 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 362 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 446 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which placebo is the first listed.

NCT01099449 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01099449 about?

NCT01099449 is a clinical study titled "Calcium Gluconate and Magnesium Sulfate in Preventing Neurotoxicity in Patients With Colon Cancer or Rectal Cancer Receiving Oxaliplatin-Based Combination Chemotherapy". RATIONALE: Chemoprotective drugs, such as calcium gluconate and magnesium sulfate, may prevent neurotoxicity caused by oxaliplatin. It is not yet known which administration schedule of calcium gluconate and magnesium sulfate is more effective in preventing neurotoxicity. PURPOSE: This randomized ph...

What is the current status of trial NCT01099449?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 362 participants. The study started on 2010-06. Estimated completion is 2013-03.

What interventions are being tested in trial NCT01099449?

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

Who is sponsoring clinical trial NCT01099449?

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

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.