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Predictive Value of Pet Scan With Fdg Performed During Irradiation in Patients Treated for Oesaphagus Carcinoma (RTEP3)
This study is currently recruiting participants.
Verified July 2009 by Centre Henri Becquerel

First Received on July 7, 2009.   Last Updated on December 15, 2010   History of Changes
Sponsor: Centre Henri Becquerel
Information provided by: Centre Henri Becquerel
ClinicalTrials.gov Identifier: NCT00934505
  Purpose

The poor prognosis in the early-stage of oeasophagus carcinoma cancer is due to potential worsening of the disease (local relapse, metastasis), to insufficient efficacy and toxicity of actual treatments.

FDG-PET is a medical imaging modality allowing the quantification of the tumour glucose consumption. Then, this exam is used for pathology staging, target volume definition for RT, and treatment efficiency few months after CRT. Our assumption is that an FDG-PET exam during the course of CRT might be predictive of the treatment efficiency few months later.

In this study, we propose to perform 4 FDG-PET: first "PET1" before chemo-radiotherapy, second "PET2" during the chemo-radiotherapy (see RTEP1), third and fourth "PET3" "PET4" 3month and 12 month after the end of radiotherapy.

We will investigate the performances of FDG-PET performed during CRT for the prediction of the one-year patient heath outcome. If the predictive value of TEP2 is confirmed, we would be able to optimize the planning treatment during the course of the therapy.


Condition
Oesaphagus Carcinoma Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Predictive Value of FDG-TEP During Exclusive Chemo-Radiotherapy (CRT) in Patients With Oesophagus Carcinoma Cancer on the One-Year Survival (RTEP3)

Resource links provided by NLM:


Further study details as provided by Centre Henri Becquerel:

Estimated Enrollment: 100
Study Start Date: May 2009
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Diagnosed patients a carcinoma of the oesophagus histologiquement proved

Criteria

Inclusion Criteria:

  • Carcinoma épidermoïde of the oesophagus histologically proved, UICC Stage II B, III or IVa (TNM on 2002)
  • Decision of treatment by radio concomitant chemotherapy (radiotherapy in classic spreading of 50Gy associated with a platinum chemotherapy.

Exclusion Criteria:

  • Presence of a second evolutionary cancer in the previous three years
  • index of performance OMS > 2
  • Patients badly balanced diabetics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00934505

Contacts
Contact: THILLAYS Marc, RCA 00330232082497 marc.thillays@rouen.fnclcc.fr

Locations
France
CLCC H.Becquerel Recruiting
Rouen, Haute Normandie, France, 76000
Contact: THILLAYS Marc, RT     0033232082497     marc.thillays@touen.fnclcc.fr    
Contact: GOUEL Pierrick, RT     0033232082497     pierrick.gouel@rouen.fnclcc.fr    
Sub-Investigator: BENYOUCEF Ahmed, MD            
Sponsors and Collaborators
Centre Henri Becquerel
Investigators
Principal Investigator: VERA Pierre, MD phD CHBecquerel
Principal Investigator: MICHEL Pierre, MD phD CHRU Rouen
  More Information

No publications provided

Responsible Party: PU PH VERA Pierre, CHBecquerel
ClinicalTrials.gov Identifier: NCT00934505     History of Changes
Other Study ID Numbers: CHB08-02
Study First Received: July 7, 2009
Last Updated: December 15, 2010
Health Authority: France: Institutional Ethical Committee

Keywords provided by Centre Henri Becquerel:
Positron-Emission Tomography
PET Scan
FDG
Oesophagus Carcinoma cancer
chemo-Radiation Oncology
SUV

Additional relevant MeSH terms:
Carcinoma
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on February 09, 2012