Study of the Fixation of Various Vectors in PET/CT in Patients With a With Lung Cancer Before and During of CRT or RT

Carcinoma, Non-Small-Cell Lung Clinical Trial

— RTEP4  

Official title:

Study of the Modification of the Fixation of FDG, F-Miso and FLT Measured in PET/CT at Patients Before and in the Course of Exclusive Radiotherapy or Concomitant Radiochemotherapy for Primitive Bronchial Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01261585
• Other study ID #: CHB 08-01
• Status: Completed
• Phase: N/A
• First received: December 15, 2010
• Last updated: December 15, 2010
• Start date: December 2008
• Est. completion date: December 2009

Study information

• Verified date: January 2009
• Source: Centre Henri Becquerel
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Observational

Clinical Trial Summary

Study of the modification of the fixation(binding) of Fluoro-2-deoxy-D-glucose (FDG), fluoro-misonidazole (FMISO) and 3'deoxy-3-fluoro-thymidine deoxy-3-fluoro-thymidine (FLT) measured in tomography by broadcast(emission,issue) of positrons (PET) at patients before and in the course of exclusive radiotherapy or concomitant radiochemotherapy for primitive bronchial cancer.

This protocle allows to study the simultaneous variations of the metabolism, the hypoxie and the cellular proliferation by PET SCAN at 5 patients reached(affected) by a primitive bronchial cancer in the course of exclusive radiotherapy for primitive bronchial cancer not small cell lung.

The investigators are also going to study several scenarii of optimization of the radiotherapy according to the variations of the tumoral metabolism, the hypoxie and the cellular proliferation measured in the course of radiotherapy (theoretical study on console using the scanner and the various examinations).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: December 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• patients with non-small-cell lung carcinoma hitologicaly proved

• Candidate patients in a treatment with aim guardian by exclusive thoracic radiotherapy or of concomitant radiochemotherapy (tumoral dose superior to 60 Gy) ( n=5 ).

• Measurable tumor according to the criteria of evaluation RECIST

Exclusion Criteria:

• Histology other one than primitive bronchial cancer not in small cells lung

• The patients for whom no tumoral target is assessable (forgiveness completes after first chemotherapy, operated patients).

• Patients for whom a radiotherapy with curative aim is not indicated (tumoral extension, metastases, general state, co-morbidity).

• Patient having benefited from an examination PET in the FDG with in more than 4 weeks and for which a new PET in the FDG is not necessary with in the framework of its disease

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Bronchial Neoplasms
• Carcinoma, Non-Small-Cell Lung

Locations

Country	Name	City	State
France	Centre Henri Becquerel	Rouen	Hate Normandie

Sponsors (1)

Lead Sponsor	Collaborator
Centre Henri Becquerel

Country where clinical trial is conducted

France,