Role of PET Scan in the Evaluation of Early Response to Maintenance Treatment in Advanced Non-small-cell Lung Cancer

Non-small Cell Lung Cancer Clinical Trial

— CALMETTE  

Official title:

Role of 18FDG PET in the Evaluation of Early Response to Maintenance Treatment With Bevacizumab or Pemetrexed in Advanced Non-small-cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02507518
• Other study ID #: CHB12.01
• Status: Recruiting
• Phase: Phase 2
• Start date: December 2013
• Est. completion date: March 2019

Study information

• Verified date: July 2018
• Source: Centre Henri Becquerel
• Contact: Stéphanie Becker, MD
• Phone: +33232082258
• Email: stephanie.becker[@]chb.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Non small cell lung cancer is the first cause of cancer related death in France and is becoming an increasing health problem in developing countries.

Recently for patient with no progression disease after first line chemotherapy, new therapies were validated in maintenance (bevacizumab) or switch maintenance treatment (erlotinib, pemetrexed) with improved survival.

Until now, determination of efficiency of treatment is only based on morphological response (RECIST) and remains inappropriate to such cytostatic drugs for which there is no anatomical lesion modification.

Nuclear Medicine and especially 18-FDG Positron Emission Tomography (PET) offers a biologically relevant tool for assessment of tumour response therapies.

The assumption of the study is that FDG PET would allow to earlier detect a lack of response, thereafter, to modify an ineffective treatment. Indeed, nowadays the treatment is maintained up to evidence of progression disease.

However, despite the increasing use of FDG PET for predicting therapeutic response, there are no validated criteria for judging response of maintenance therapy in non-small cell lung cancer.

It seems necessary to determine standardized criteria response, earlier during the course of maintenance therapy in patient with non small cell lung cancer.

The final aim is to optimize survival by an adapted metabolic imaging guided therapy.

Description:

The purpose of the study is to optimize survival by an adapted metabolic imaging therapy in patients with advances non-small cell lung cancer.

The primary objective of the study is to evaluate the role of SUV and metabolic volume measured by FDG PETScan in the early prediction of treatment response.

80 patients will be included in 2 years. They will be follow up for one year for monitoring the progression free survival.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age superior to 18 years old

• Effective contraception method or negative pregnancy test at the inclusion

• OMS inferior or equal to 1

• Non-small cell lung cancer stage IIIb or IV

• Non progressive disease after at lest 4 cycles of platinum-based chemotherapy

• Eligible fo maintenance therapy with bevacizumab and/or pemetrexed

• Inform consent signed

Exclusion Criteria:

• Evolution of a second cancer in the 3 years before inclusion

• Pregnancy or breast-feeding

• poorly controlled diabetes

• curatorship or guardianship

• contraindication to iodinated contrast agents

• participation to another clinical research with an experimental drug

• impossible decubitus

• not possibility to follow-up the procedures of the study due to geographic, social or psychic reasons

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Procedure:
• PET scan imaging
a PET scan will be done 2 weeks before the start of maintenance therapy and another 16 days after to predict the earlier response to treatment

Locations

Country	Name	City	State
France	CHU Rouen-Hôpital Bois-Guillaume	Bois-Guillaume
France	CH Dieppe	Dieppe
France	Centre hospitalier intercommunal Elbeuf Louviers	Elbeuf
France	Centre Henri Becquerel	Rouen
France	CHU Rouen	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Henri Becquerel

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression free survival	time between the start of maintenance therapy and progression	16 weeks after the start of maintenance therapy
Secondary	progression free survival	time between the start of maintenance therapy and progression or death	on year