Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04137107 · ClinicalTrials.gov registry record · Phase 2
Duloxetine to Prevent Oxaliplatin-Induced Peripheral Neuropathy in Patients With Stage II-III Colorectal Cancer
A Phase 2 study of Stage III Colorectal Cancer AJCC v8 and Stage II Colorectal Cancer AJCC v8, sponsored by Alliance for Clinical Trials in Oncology.
- Active
- Registry status
- Phase 2
- Development phase
- 220
- Enrollment target
- 20
- Study locations
NCT04137107 is a Phase 2 study of Stage III Colorectal Cancer AJCC v8 and Stage II Colorectal Cancer AJCC v8 that is active but no longer recruiting, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 220 participants, above the 115-participant average among 17 other Stage III Colorectal Cancer AJCC v8 trials with a reported enrollment target (91% higher). The trial reports 20 study locations across 5 states.
The verdict
NCT04137107, a Phase 2 study of Stage III Colorectal Cancer AJCC v8 and Stage II Colorectal Cancer AJCC v8, is active but no longer recruiting, sponsored by Alliance for Clinical Trials in Oncology.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 220 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II/III trial studies the best dose of duloxetine and how well it works in preventing pain, tingling, and numbness (peripheral neuropathy) caused by treatment with oxaliplatin in patients with stage II-III colorectal cancer. Duloxetine increases the amount of certain chemicals in the brain that help relieve depression and pain. Giving duloxetine in patients undergoing treatment with oxaliplatin for colorectal cancer may help prevent peripheral neuropathy.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- DRUG Duloxetine
- DRUG Oxaliplatin
- OTHER Questionnaire Administration
- DRUG Duloxetine Hydrochloride
Study Locations (20)
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Anchorage Radiation Therapy Center - Anchorage
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
- CARTI Cancer Center - Little Rock
- John L McClellan Memorial Veterans Hospital - Little Rock
- University of Arkansas for Medical Sciences - Little Rock
California
- Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande
- PCR Oncology - Arroyo Grande
- Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
- University of South Alabama Mitchell Cancer Institute - Mobile
Arizona
- Kingman Regional Medical Center - Kingman
- Cancer Center at Saint Joseph's - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2020-06-17 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04137107
The ClinicalTrials.gov registry entry for NCT04137107 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 220 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 115-participant average among 17 other Stage III Colorectal Cancer AJCC v8 trials with a reported enrollment target (91% higher). 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 Stage III Colorectal Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.
NCT04137107 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Alaska, Arkansas, California.
Frequently Asked Questions
What is clinical trial NCT04137107 about?
NCT04137107 is a clinical study titled "Duloxetine to Prevent Oxaliplatin-Induced Peripheral Neuropathy in Patients With Stage II-III Colorectal Cancer". This phase II/III trial studies the best dose of duloxetine and how well it works in preventing pain, tingling, and numbness (peripheral neuropathy) caused by treatment with oxaliplatin in patients with stage II-III colorectal cancer. Duloxetine increases the amount of certain chemicals in the brain...
What is the current status of trial NCT04137107?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 220 participants. The study started on 2020-06-17. Estimated completion is 2026-12-31.
What conditions does trial NCT04137107 study?
This clinical trial studies the following conditions: Stage III Colorectal Cancer AJCC v8, Stage II Colorectal Cancer AJCC v8.
What interventions are being tested in trial NCT04137107?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Duloxetine (DRUG), Oxaliplatin (DRUG), Questionnaire Administration (OTHER), Duloxetine Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT04137107?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04137107 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stage III Colorectal Cancer AJCC v8
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Circulating Cell-Free Tumor DNA Testing in Guiding Treatment for Patients With Advanced or Metastatic Colorectal Cancer
ACTIVE NOT RECRUITING · Phase 2
-
Danvatirsen and Durvalumab in Treating Patients With Advanced and Refractory Pancreatic, Non-Small Cell Lung Cancer, and Mismatch Repair Deficient Colorectal Cancer
ACTIVE NOT RECRUITING · Phase 2
-
Regorafenib, With Cetuximab or Panitumumab, for the Treatment of Unresectable, Locally Advanced, or Metastatic Colorectal Cancer
ACTIVE NOT RECRUITING · Phase 2
-
Linaclotide in Treating Patients With Stages 0-3 Colorectal Cancer
ACTIVE NOT RECRUITING · Phase 2
-
Panitumumab, Regorafenib, or TAS-102, in Treating Patients With Metastatic and/or Unresectable RAS Wild-Type Colorectal Cancer
ACTIVE NOT RECRUITING · Phase 2
-
Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer
RECRUITING · Phase 1
Explore more on PlainTrial
Stage III Colorectal Cancer AJCC v8
All registered trials for this condition
Stage II Colorectal Cancer AJCC v8
All registered trials for this condition
Alabama
All trials with a study site in Alabama
Recruiting now
Find trials open to new participants near you
Rankings
Top sponsors, conditions, and phases
Read our methodology - how this data is sourced, computed, and verified.
Related
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.