Trials / Active Not Recruiting
Active Not RecruitingNCT03110926
Induction Chemotherapy for Locally Advanced Esophageal Cancer
Induction Chemotherapy for Locally Advanced Esophageal Cancer: A Phase II Study
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- University of Rochester · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Evaluate mFOLFOX6 (5-Fluorouracil, Leucovorin and Oxaliplatin) chemotherapy as induction treatment prior to standard neoadjuvant chemoradiation to decrease the rate of distant recurrence among patients with locally advanced esophageal cancer.
Detailed description
The goal of the study is to evaluate mFOLFOX6 (5-Fluorouracil, Leucovorin and Oxaliplatin) chemotherapy as induction treatment prior to standard neoadjuvant chemoradiation to decrease the rate of distant recurrence among patients with locally advanced esophageal cancer. mFOLFOX6 is frequently used to treat metastatic esophageal cancer because of its high response rate in this setting. It has shown promising efficacy in several trials of patients with advanced esophageal cancer and it is the most commonly used combination regimen for this group of patients in the United States. The investigators propose treating a sample of 40 patients with 3 cycles of induction mFOLFOX6 chemotherapy over six weeks followed by standard chemoradiation and surgery. The investigators hypothesize that patients who undergo induction chemotherapy with mFOLFOX6 prior to standard neoadjuvant chemoradiation and surgery will have a lower rate of distant disease recurrence compared to standard neoadjuvant chemoradiation and surgery.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | mFOLFOX6 | Induction Chemotherapy |
| COMBINATION_PRODUCT | Chemoradiation | Chemoradiation |
Timeline
- Start date
- 2017-06-19
- Primary completion
- 2027-05-31
- Completion
- 2027-05-31
- First posted
- 2017-04-12
- Last updated
- 2025-09-12
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03110926. Inclusion in this directory is not an endorsement.