Predictive Value of FDG-TEP During Radiotherapy or Chemo-radiotherapy in Patients With NCSC on the One-year Survival

NCT01261598 | Completed DMC

• 1 other identifier: CHB06-02
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer; NSCLC

Keywords

Positron-Emission Tomography; PET Scan; Non-Small-Cell Lung Carcinoma; Radiation Oncology; SUV

Outcome Measures

Primary Outcomes (1)

• SUV max from FDG PETScan

  Measure of FDG-TEP uptake variation (SUV max) to assess predictive value of FDG-TEP during radiotherapy

  Baseline - 5 Weeks after begining of radiotherapy- 3 months after end of radiotherapy- 1 year afterwards

Secondary Outcomes (1)

• Study of several optimized radiotherapy scenary according to the quantification of the tumour glucose consumption during radiotherapy

  after the completion enrollment date

Study Arms (2)

1

OTHER

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

Procedure: Positron Emission Tomography

2

OTHER

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

Procedure: Positron Emission Tomography

Interventions

Positron Emission Tomography PROCEDURE

Positron Emission Tomography

Also known as: PET scan

1; 2

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Henri Becquerel: lead

Study Sites (1)

Centre Henri Becquerel

Rouen, 76000, France

Location

Related Publications (3)

• 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.

  PMID: 30419929 DERIVED

• 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.

  PMID: 25572091 DERIVED

• 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.

  PMID: 24562641 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Bernard DUBRAY, phD

  Centre Henri Becquerel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2010
• First Posted: December 16, 2010
• Study Start: November 1, 2007
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 17, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)