Predictive Value of FDG-TEP During Radiotherapy or Chemo-radiotherapy in Patients With NCSC on the One-year Survival
NCT ID: NCT01261598
Last Updated: 2016-10-17
Study Results
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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COMPLETED
NA
98 participants
INTERVENTIONAL
2007-11-30
2013-12-31
Brief Summary
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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 RT or CRT. Our assumption is that an FDG-PET exam during the course of the RT or CRT might be predictive of the treatment efficiency few months later.
In this study, the investigators propose to perform 4 FDG-PET: first "PET1" before radiotherapy, second "PET2" during the radiotherapy (see RTEP1), third and fourth "PET3" "PET4" 3month and 12 month after the therapy.
The investigators will investigate the performances of FDG-PET performed during the RT or CRT for the prediction of the one-year patient heath outcome. If the predictive value of TEP2 is confirmed, the investigators would be able to optimize the planning treatment during the course of the therapy.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
NONE
Study Groups
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1
Patients treated with curative and exclusive radiotherapy (60 Gy minimum), with possibly prior chemotherapy
Positron Emission Tomography
Positron Emission Tomography
2
Patient treated with concomitant chemotherapy and radiotherapy (60 Gy minimum), with possibly prior chemotherapy chemotherapy Treatment
Positron Emission Tomography
Positron Emission Tomography
Interventions
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Positron Emission Tomography
Positron Emission Tomography
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Fertile patients must use effective contraception
* WHO performance status \<2
* Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (≥ 10 mm with spiral CT scan)
Exclusion Criteria
* Baseline fludeoxyglucose F 18 (FDG)-positron emission tomography (PET) scan without any target lesion
* Unable to under PET CT evaluation
* other concurrent investigational agents
* No Planning to undergo curative intent radiotherapy
* familial, social, geographic, or psychological conditions that would preclude study participation
* Prior malignancy progressive disease
18 Years
ALL
No
Sponsors
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Centre Henri Becquerel
OTHER
Responsible Party
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Principal Investigators
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Bernard DUBRAY, phD
Role: PRINCIPAL_INVESTIGATOR
Centre Henri Becquerel
Locations
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Centre Henri Becquerel
Rouen, , France
Countries
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References
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Ganem J, Thureau S, Gardin I, Modzelewski R, Hapdey S, Vera P. Delineation of lung cancer with FDG PET/CT during radiation therapy. Radiat Oncol. 2018 Nov 12;13(1):219. doi: 10.1186/s13014-018-1163-2.
Calais J, Thureau S, Dubray B, Modzelewski R, Thiberville L, Gardin I, Vera P. Areas of high 18F-FDG uptake on preradiotherapy PET/CT identify preferential sites of local relapse after chemoradiotherapy for non-small cell lung cancer. J Nucl Med. 2015 Feb;56(2):196-203. doi: 10.2967/jnumed.114.144253. Epub 2015 Jan 8.
Vera P, Mezzani-Saillard S, Edet-Sanson A, Menard JF, Modzelewski R, Thureau S, Meyer ME, Jalali K, Bardet S, Lerouge D, Houzard C, Mornex F, Olivier P, Faure G, Rousseau C, Mahe MA, Gomez P, Brenot-Rossi I, Salem N, Dubray B. FDG PET during radiochemotherapy is predictive of outcome at 1 year in non-small-cell lung cancer patients: a prospective multicentre study (RTEP2). Eur J Nucl Med Mol Imaging. 2014 Jun;41(6):1057-65. doi: 10.1007/s00259-014-2687-9. Epub 2014 Feb 22.
Other Identifiers
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CHB06-02
Identifier Type: -
Identifier Source: org_study_id
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