Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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 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.

View on ClinicalTrials.gov ↗

View your shortlist →

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

Conditions Studied

Adenocarcinoma of the Gastroesophageal Junction Stage III Gastric Cancer Adenocarcinoma of the Stomach Adenocarcinoma of the Esophagus Stage II Gastric Cancer Stage III Esophageal Cancer Squamous Cell Carcinoma of the Esophagus Stage II Esophageal Cancer

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

FieldValue
Enrollment Target 9 participants
Start Date 2007-04
Est. Completion 2009-03
Phase Phase 1

Sponsor

Wake Forest University Health Sciences

1,140 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01561014

The ClinicalTrials.gov registry entry for NCT01561014 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 91-participant average among 7 other Adenocarcinoma of the Gastroesophageal Junction trials with a reported enrollment target (90% lower). The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

Learn More About Clinical Trials

Similar trials for Adenocarcinoma of the Gastroesophageal Junction

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.

Explore more on PlainTrial

Adenocarcinoma of the Gastroesophageal Junction

All registered trials for this condition

Stage III Gastric Cancer

All registered trials for this condition

North Carolina

All trials with a study site in North Carolina

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

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.