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

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

COMPLETED

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2013-12-31

Brief Summary

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The poor prognosis in the early-stage of lung 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 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.

Detailed Description

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Conditions

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Lung Cancer NSCLC

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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1

Patients treated with curative and exclusive radiotherapy (60 Gy minimum), with possibly prior chemotherapy

Group Type OTHER

Positron Emission Tomography

Intervention Type PROCEDURE

Positron Emission Tomography

2

Patient treated with concomitant chemotherapy and radiotherapy (60 Gy minimum), with possibly prior chemotherapy chemotherapy Treatment

Group Type OTHER

Positron Emission Tomography

Intervention Type PROCEDURE

Positron Emission Tomography

Interventions

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Positron Emission Tomography

Positron Emission Tomography

Intervention Type PROCEDURE

Other Intervention Names

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PET scan

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed non-small cell lung cancer
* 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

* Pregnant or lactating females
* 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
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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Bernard DUBRAY, phD

Role: PRINCIPAL_INVESTIGATOR

Centre Henri Becquerel

Locations

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Centre Henri Becquerel

Rouen, , France

Site Status

Countries

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France

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.

Reference Type DERIVED
PMID: 30419929 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25572091 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24562641 (View on PubMed)

Other Identifiers

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CHB06-02

Identifier Type: -

Identifier Source: org_study_id

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