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

NCT00934505 | Unknown DMC

• 1 other identifier: CHB08-02
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oesophageal Cancer

Keywords

Positron-Emission Tomography; PET Scan; FDG; oesophageal cancer; chemo-Radiation Oncology; SUV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Diagnosed patients a carcinoma of the oesophagus histologiquement proved

You may qualify if:

• 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.

You may not qualify if:

• Presence of a second evolutionary cancer in the previous three years
• index of performance OMS \> 2
• Patients badly balanced diabetics

Sponsors & Collaborators

• Centre Henri Becquerel: lead

Study Sites (1)

CLCC H.Becquerel

Rouen, Haute Normandie, 76000, France

RECRUITING

Related Publications (2)

• Nkhali L, Thureau S, Edet-Sanson A, Doyeux K, Benyoucef A, Gardin I, Michel P, Vera P, Dubray B. FDG-PET/CT during concomitant chemo radiotherapy for esophageal cancer: Reducing target volumes to deliver higher radiotherapy doses. Acta Oncol. 2015 Jun;54(6):909-15. doi: 10.3109/0284186X.2014.973062. Epub 2014 Nov 24.

  PMID: 25417733 DERIVED

• Palie O, Michel P, Menard JF, Rousseau C, Rio E, Bridji B, Benyoucef A, Meyer ME, Jalali K, Bardet S, M'vondo CM, Olivier P, Faure G, Itti E, Diana C, Houzard C, Mornex F, Di Fiore F, Vera P. The predictive value of treatment response using FDG PET performed on day 21 of chemoradiotherapy in patients with oesophageal squamous cell carcinoma. A prospective, multicentre study (RTEP3). Eur J Nucl Med Mol Imaging. 2013 Sep;40(9):1345-55. doi: 10.1007/s00259-013-2450-7. Epub 2013 May 29.

  PMID: 23715903 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• VERA Pierre, MD phD

  CHBecquerel

  PRINCIPAL INVESTIGATOR

• MICHEL Pierre, MD phD

  CHRU Rouen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

THILLAYS Marc, RCA

CONTACT

00330232082497; marc.thillays@rouen.fnclcc.fr

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2009
• First Posted: July 8, 2009
• Study Start: May 1, 2009
• Primary Completion: March 1, 2013
• Study Completion: April 1, 2014
• Last Updated: May 25, 2012

Record last verified: 2011-03

Locations

FR (1)