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NCT02311907 · ClinicalTrials.gov registry record · Phase 3
Glutathione in Preventing Peripheral Neuropathy Caused by Paclitaxel and Carboplatin in Patients With Ovarian Cancer, Fallopian Tube Cancer, and/or Primary Peritoneal Cancer
A Phase 3 study, sponsored by Alliance for Clinical Trials in Oncology.
- Completed
- Registry status
- Phase 3
- Development phase
- 195
- Enrollment target
NCT02311907: Completed Phase 3 study, sponsored by Alliance for Clinical Trials in Oncology.
NCT02311907 is a Phase 3 study that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 195 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02311907, a Phase 3 study, has completed, sponsored by Alliance for Clinical Trials in Oncology.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 195 participants
- Enrollment target
Study Summary
This randomized phase III trial is studying glutathione to see how well it works in preventing peripheral neuropathy caused by paclitaxel and carboplatin in patients with ovarian cancer, fallopian tube cancer, and/or primary peritoneal cancer. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Chemoprotective drugs, such as glutathione, may help prevent peripheral neuropathy caused by paclitaxel and carboplatin. It is not yet known whether glutathione is more effective than a placebo in preventing peripheral neuropathy.
Primary Outcome
The CIPN sensory subscale will be calculated by standard scoring algorithm and converted to 0-100 scale (higher scores indicated less symptoms and better quality of life). Generalized linear models (repeated measures analysis of variance \[ANOVA\] if data are complete) will be used to compare the CIPN between Glutathione (GSH) and placebo arms.
Interventions
- DRUG Carboplatin
- OTHER Placebo
- OTHER Laboratory Biomarker Analysis
- DRUG Paclitaxel
- DRUG Glutathione
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 195 participants |
| Start Date | 2009-12 |
| Est. Completion | 2012-08 |
| Phase | Phase 3 |
What the finished NCT02311907 record still lists
NCT02311907 is an interventional study that assigns participants to a tested intervention. The registered 195 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 (75% lower).
The record links to 0 conditions, and to 5 interventions - of which Carboplatin is the first listed.
NCT02311907 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02311907 about?
NCT02311907 is a clinical study titled "Glutathione in Preventing Peripheral Neuropathy Caused by Paclitaxel and Carboplatin in Patients With Ovarian Cancer, Fallopian Tube Cancer, and/or Primary Peritoneal Cancer". This randomized phase III trial is studying glutathione to see how well it works in preventing peripheral neuropathy caused by paclitaxel and carboplatin in patients with ovarian cancer, fallopian tube cancer, and/or primary peritoneal cancer. Drugs used in chemotherapy work in different ways to sto...
What is the current status of trial NCT02311907?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 195 participants. The study started on 2009-12. Estimated completion is 2012-08.
What interventions are being tested in trial NCT02311907?
The interventions under investigation include: Carboplatin (DRUG), Placebo (OTHER), Laboratory Biomarker Analysis (OTHER), Paclitaxel (DRUG), Glutathione (DRUG).
Who is sponsoring clinical trial NCT02311907?
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 NCT02311907's enrollment target sits among peer trials
195 1393rd of 2000 higher than 606 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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