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NCT01561014 · ClinicalTrials.gov registry record · Phase 1
Oxaliplatin, Fluorouracil, Erlotinib Hydrochloride, and Radiation Therapy Before Surgery and Erlotinib Hydrochloride After Surgery in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction
A Phase 1 study of Adenocarcinoma of the Gastroesophageal Junction and Stage III Gastric Cancer, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
- 1
- Study location
NCT01561014: Completed Phase 1 study of Adenocarcinoma of the Gastroesophageal Junction and Stage III Gastric Cancer, sponsored by Wake Forest University Health Sciences.
NCT01561014 is a Phase 1 study of Adenocarcinoma of the Gastroesophageal Junction and Stage III Gastric Cancer that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 9 participants, below the 91-participant average among 7 other Adenocarcinoma of the Gastroesophageal Junction trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01561014, a Phase 1 study of Adenocarcinoma of the Gastroesophageal Junction and Stage III Gastric Cancer, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial is studying the side effects and best dose of erlotinib hydrochloride when given together with oxaliplatin, fluorouracil, and radiation before surgery and alone after surgery in treating patients with locally advanced cancer of the esophagus and gastroesophageal junction. Drugs used in chemotherapy, such as oxaliplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with erlotinib hydrochloride and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving erlotinib hydrochloride after surgery may kill any tumor cells that remain after surgery
Primary Outcome
Toxicity will be determined using the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 3.0 for Toxicity and Adverse Event Reporting (CTCAE v3.0). The dose limiting toxicity will be defined as any of the following that can be attributal to therapy: Any grade 4 neutropenia and or any grade 4 thrombocytopenia, or any \>= grade 3 non-hematologic toxicity that results in a greater than 3 day interruption of therapy.
Conditions Studied
Interventions
- DRUG oxaliplatin
- DRUG fluorouracil
- PROCEDURE conventional surgery
- RADIATION radiation therapy
- DRUG erlotinib hydrochloride
Study Locations (1)
North Carolina
- Wake Forest University Health Sciences - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2007-04 |
| Est. Completion | 2009-03 |
| Phase | Phase 1 |
What the finished NCT01561014 record still lists
NCT01561014 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 91-participant average among 7 other Adenocarcinoma of the Gastroesophageal Junction trials with a reported enrollment target (90% lower).
The record links to 8 conditions, with Adenocarcinoma of the Gastroesophageal Junction appearing as the primary indexed condition, and to 5 interventions - of which oxaliplatin is the first listed.
NCT01561014 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT01561014 about?
NCT01561014 is a clinical study titled "Oxaliplatin, Fluorouracil, Erlotinib Hydrochloride, and Radiation Therapy Before Surgery and Erlotinib Hydrochloride After Surgery in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction". This phase I trial is studying the side effects and best dose of erlotinib hydrochloride when given together with oxaliplatin, fluorouracil, and radiation before surgery and alone after surgery in treating patients with locally advanced cancer of the esophagus and gastroesophageal junction. Drugs us...
What is the current status of trial NCT01561014?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2007-04. Estimated completion is 2009-03.
What conditions does trial NCT01561014 study?
This clinical trial studies the following conditions: Adenocarcinoma of the Gastroesophageal Junction, Stage III Gastric Cancer, Adenocarcinoma of the Stomach, Adenocarcinoma of the Esophagus, Stage II Gastric Cancer.
What interventions are being tested in trial NCT01561014?
The interventions under investigation include: oxaliplatin (DRUG), fluorouracil (DRUG), conventional surgery (PROCEDURE), radiation therapy (RADIATION), erlotinib hydrochloride (DRUG).
Who is sponsoring clinical trial NCT01561014?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01561014 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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