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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: Completed Phase 3 study, sponsored by Alliance for Clinical Trials in Oncology.
NCT01099449 is a Phase 3 study that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 362 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The oxaliplatin-induced sensory neuropathy as repeatedly measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire of Chemotherapy-induced peripheral neuropathy (EORTC QLQ-CIPN20) sensory subscale during the chemotherapy. This is a multivariate repeated measurement of CIPN with possibly variable cycles for every patient. The CIPN sensory subscale will be calculated by standard scoring algorithm and converted to 0-100 scale, where higher scores repre
Interventions
- OTHER placebo
- DRUG oxaliplatin
- DRUG magnesium sulfate
- DRUG calcium gluconate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 362 participants |
| Start Date | 2010-06 |
| Est. Completion | 2013-03 |
| Phase | Phase 3 |
What the finished NCT01099449 record still lists
NCT01099449 is an interventional study that assigns participants to a tested intervention. The registered 362 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 4 interventions - of which placebo is the first listed.
NCT01099449 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01099449's enrollment target sits among peer trials
362 1007th of 2000 higher than 993 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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