Clinical trial NCT00915096: Positron Emission Tomography (PET)-Scan in the Evaluation of High Tumor Burden Follicular Lymphoma
Official title: High Tumor Burden Follicular Lymphoma: Impact of [18F]-FDG Positron Emission Tomography (PET) in the Assessment of Treatment Response
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma, Follicular
Keywords: Follicular Lymphoma
PET
GELA
Lead sponsor: Lymphoma Study Association
Sponsor class: OTHER
First posted: 2009-06-05
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: High Tumor Burden Follicular Lymphoma patients

Brief summary: The purpose of the study is to assess in a prospective series of patients with high tumor burden follicular lymphoma treated with R-CHOP, the predictive value of \[18F\]-FDG PET performed over (after 4 treatments), and at the end of the first-line treatment on progression-free survival at 2 years.


Eligibility criteria: Inclusion Criteria:

* Patients with malignant non-Hodgkin follicular lymphoma (histologic grade 1 to 3 in the WHO classification), histologically confirmed,
* Patients who have not previously been treated for this disease,
* Introducing one of the criteria for high tumor burden,
* Patients aged over 18 and under 80 years,
* Patients whose ECOG condition is ≤ 2,
* Patients whose haematological functions are adequate within 28 days preceding the treatment (Hemoglobin ≥8,0g/dl; Neutrophils ≥1,5e-9/L, Platelets ≥100e-9/L),
* Patient had the PET examination less than a month before the start of chemotherapy.

Exclusion Criteria:

* Patients with lymphoma who have already transformed or been treated for this disease,
* Patients whose lymphoma is stage 3b,
* Patients with impaired central nervous system,
* Patients regularly taking corticosteroids during the 4 weeks preceding the treatment (unless the dose administered is equivalent to ≤20 mg/day prednisone).
* Patients who have undergone major surgery during the 28 days preceding the inclusion,
* Patients with low kidney and/or liver function,
* Patients with HIV + or had an infection with HBV or HCV less than 4 weeks. Patients with hepatitis B serology is positive unless the sign is related to vaccination,
* Patients whose life expectancy ≤ 6 months,
* Patients sensitive or allergic to murine products,
* Patients who participated in another clinical trial during the 30 days preceding the recording,
* Patients with other medical problems or psychological succeptibles interfere with the study,
* Patients under adult supervision.

Primary outcomes:
measure: Predictive value of PET on progression-free survival
timeFrame: 2 years
Secondary outcomes:
measure: Comparison of PET results to treatment response (Cheson criteria)
timeFrame: 30 weeks
measure: Correlation of PET data with FLIPI index score
timeFrame: Baseline
measure: Comparison of changes in lymph node volumes measured by CT to changing of FDG fixation
timeFrame: 30 weeks
measure: Correlation of PET data with histopathological data (including the use of immunohistochemical markers)
timeFrame: Baseline
measure: Evaluation of the sensitivity of PET in the detection of the involvement of hematopoietic marrow
timeFrame: Baseline
measure: Comparison of conventional criteria for evaluating the response to the criteria "revised" by the international workshop criteria
timeFrame: 30 weeks
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU - Besançon
city: Bobigny
country: France
facility: CHU Avicenne
city: Bordeaux
country: France
facility: Centre Bergognié
city: Créteil
country: France
facility: Hôpital Henri Mondor
city: Dijon
country: France
facility: CHU de Dijon
city: Le Mans
country: France
facility: Clinique Victor Hugo
city: Lens
country: France
facility: Centre Hospitalier - Lens
city: Lille
country: France
facility: CHRU Lille
city: Limoges
country: France
facility: CHU - Limoges
city: Marseille
country: France
facility: Centre Paoli-Calmettes
city: Nantes
country: France
facility: CHU - Nantes
city: Paris
country: France
facility: Hôpital Necker
city: Paris
country: France
facility: Hôpital Pitié-Salpêtrière
city: Paris
country: France
facility: Hôpital Saint-Louis
city: Pierre Benite
country: France
facility: CHU Lyon Sud
city: Reims
country: France
facility: CHU Robert Debré
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Toulouse
country: France
facility: CHU Purpan
city: Tours
country: France
facility: Hôpital Bretonneau
city: Vandoeuvre les Nancy
country: France
facility: CHU Brabois
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Cuneo
country: Italy
facility: Ospedale Cuneo
Study officials:
affiliation: Lymphoma Study Association
name: Michel MEIGNAN, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Lymphoma Study Association
name: Jehan DUPUIS, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dupuis J, Berriolo-Riedinger A, Julian A, Brice P, Tychyj-Pinel C, Tilly H, Mounier N, Gallamini A, Feugier P, Soubeyran P, Colombat P, Laurent G, Berenger N, Casasnovas RO, Vera P, Paone G, Xerri L, Salles G, Haioun C, Meignan M. Impact of [(18)F]fluorodeoxyglucose positron emission tomography response evaluation in patients with high-tumor burden follicular lymphoma treated with immunochemotherapy: a prospective study from the Groupe d'Etudes des Lymphomes de l'Adulte and GOELAMS. J Clin Oncol. 2012 Dec 10;30(35):4317-22. doi: 10.1200/JCO.2012.43.0934. Epub 2012 Oct 29.