Chemotherapy and Radiation Therapy in Treating Patients With Invasive Cancer of the Esophagus - Full Text View

Sponsored by:	Centre Oscar Lambret
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00932815

Purpose

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This phase IV trial is continuing to study how well giving chemotherapy together with radiation therapy works in treating patients with invasive cancer of the esophagus.

Condition	Intervention	Phase
Esophageal Cancer	Drug: systemic chemotherapy Genetic: proteomic profiling Other: laboratory biomarker analysis Procedure: computed tomography Procedure: endoscopic procedure Radiation: radiation therapy	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized
Official Title:	Study of Predictive Factors of Response in Patients With Esophageal Cancers Undergoing Concurrent Radiochemotherapy: Proteomic Analysis

Resource links provided by NLM:

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders Radiation Therapy

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Complete clinical response at 12-13 weeks after completion of radiotherapy [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	October 2007
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

Predict the early complete clinical response using proteomic profiling of serum and plasma samples before and after treatment.

Secondary

Predict extended clinical response at 1 year using proteomic profiling of serum and plasma samples before and after treatment.
Predict overall survival using proteomic profiling of serum and plasma samples before and after treatment.

OUTLINE: This is a multicenter study.

Patients undergo radiotherapy 5 days a week for 5-6 weeks. Patients also receive concurrent chemotherapy with a fluoropyrimidine and platinum compound beginning on day 1 of radiotherapy and continuing for 6 weeks after completion of radiotherapy.

Blood samples are collected at baseline, 14 days after beginning radiotherapy, and 12-13 weeks after completion of radiotherapy. Samples are analyzed for predictive markers of response to treatment by proteomic analysis.

Patients also undergo endoscopy and CT scans 12-13 weeks after completion of radiotherapy and at 1 year.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed invasive carcinoma of the esophagus
- Any stage disease except no metastatic disease
No Siewert type II or III cancer of the esophageal gastric-junction
Must have decided to receive concurrent chemoradiotherapy exclusively

PATIENT CHARACTERISTICS:

No other uncontrolled second malignancy

PRIOR CONCURRENT THERAPY:

No concurrent participation in another experimental drug trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00932815

Locations

France
Centre Oscar Lambret	Recruiting
Lille, France, 59020
Contact: Antoine Adenis, MD, PhD 33-320-29-59-42 a-adenis@o-lambret.fr

Sponsors and Collaborators

Centre Oscar Lambret

Investigators

Principal Investigator:

Antoine Adenis, MD, PhD

Centre Oscar Lambret

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000633509, COL-0613, COL-9/01/07, COL-2006-A00568-43, INCA-RECF0440
Study First Received:	July 2, 2009
Last Updated:	July 2, 2009
ClinicalTrials.gov Identifier:	NCT00932815 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage I esophageal cancer
stage II esophageal cancer
stage III esophageal cancer
adenocarcinoma of the esophagus

Study placed in the following topic categories:

Digestive System Neoplasms
Digestive System Diseases
Esophageal Disorder
Gastrointestinal Diseases
Head and Neck Neoplasms

Esophageal Neoplasms
Gastrointestinal Neoplasms
Esophageal Cancer
Esophageal Diseases
Adenocarcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases

Head and Neck Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Esophageal Diseases

ClinicalTrials.gov processed this record on September 10, 2009