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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 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 1,511-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (93% lower). The trial reports 14 study locations across 4 states.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2006-01 |
| Est. Completion | 2012-11 |
| Phase | Phase 3 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 104 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,511-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (93% lower). The listed sponsor is Alliance for Clinical Trials in Oncology, which has 446 total studies on file at ClinicalTrials.gov.
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 reports 14 study locations spanning 4 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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