Positron Emission Tomography (PET)-Scan in the Evaluation of High Tumor Burden Follicular Lymphoma

Completed

• Conditions: Lymphoma, Follicular

• Registration Number: NCT00915096
• Lead Sponsor: Lymphoma Study Association

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-18
• Study First Submitted: 2009-06-04
• Study First Submitted QC: 2009-06-04
• Study First Posted: 2009-06-05
• Primary Completion: 2011-05-10
• Study Completion: 2013-02-08
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-21
• Last Update Posted: 2018-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Predictive value of PET on progression-free survival	2 years

Secondary Outcome Measures

Name	Time	Method
Comparison of PET results to treatment response (Cheson criteria)	30 weeks
Comparison of changes in lymph node volumes measured by CT to changing of FDG fixation	30 weeks
Correlation of PET data with FLIPI index score	Baseline
Correlation of PET data with histopathological data (including the use of immunohistochemical markers)	Baseline
Comparison of conventional criteria for evaluating the response to the criteria "revised" by the international workshop criteria	30 weeks
Evaluation of the sensitivity of PET in the detection of the involvement of hematopoietic marrow	Baseline

Trial Locations

Locations (22)

CHU - Besançon; 🇫🇷 Besançon, France

CHU Avicenne; 🇫🇷 Bobigny, France

Centre Bergognié; 🇫🇷 Bordeaux, France

Hôpital Henri Mondor; 🇫🇷 Créteil, France

CHU de Dijon; 🇫🇷 Dijon, France

Clinique Victor Hugo; 🇫🇷 Le Mans, France

Centre Hospitalier - Lens; 🇫🇷 Lens, France

CHRU Lille; 🇫🇷 Lille, France

CHU - Limoges; 🇫🇷 Limoges, France

Centre Paoli-Calmettes; 🇫🇷 Marseille, France

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