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

NCT ID: NCT00934505

Last Updated: 2012-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Study Completion Date

2014-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Oesophageal Cancer

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Henri Becquerel

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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VERA Pierre, MD phD

Role: PRINCIPAL_INVESTIGATOR

CHBecquerel

MICHEL Pierre, MD phD

Role: PRINCIPAL_INVESTIGATOR

CHRU Rouen

Locations

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CLCC H.Becquerel

Rouen, Haute Normandie, France

Site Status RECRUITING

Countries

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France

Central Contacts

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THILLAYS Marc, RCA

Role: CONTACT

00330232082497

Facility Contacts

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THILLAYS Marc, RT

Role: primary

0033232082497

GOUEL Pierrick, RT

Role: backup

0033232082497

References

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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.

Reference Type DERIVED
PMID: 25417733 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23715903 (View on PubMed)

Other Identifiers

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CHB08-02

Identifier Type: -

Identifier Source: org_study_id

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