Predictive Value of Pet Scan With Fdg Performed During Irradiation in Patients Treated for Oesaphagus Carcinoma

Oesophageal Cancer Clinical Trial

— RTEP3  

Official title:

Predictive Value of FDG-TEP During Exclusive Chemo-Radiotherapy (CRT) in Patients With Oesophageal Carcinoma Cancer on the One-Year Survival (RTEP3)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00934505
• Other study ID #: CHB08-02
• Status: Recruiting
• Phase: N/A
• First received: July 7, 2009
• Last updated: May 24, 2012
• Start date: May 2009
• Est. completion date: April 2014

Study information

• Verified date: March 2011
• Source: Centre Henri Becquerel
• Contact: THILLAYS Marc, RCA
• Phone: 00330232082497
• Email: marc.thillays[@]rouen.fnclcc.fr
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Observational

Clinical Trial Summary

The poor prognosis in the early-stage of oesophageal 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2014
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Esophageal Neoplasms
• Oesophageal Cancer

Locations

Country	Name	City	State
France	CLCC H.Becquerel	Rouen	Haute Normandie

Sponsors (1)

Lead Sponsor	Collaborator
Centre Henri Becquerel

Country where clinical trial is conducted

France,