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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00915096
Other study ID # PET-FOL
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 18, 2007
Est. completion date February 8, 2013

Study information

Verified date August 2018
Source Lymphoma Study Association
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 121
Est. completion date February 8, 2013
Est. primary completion date May 10, 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
France 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 CHU - Nantes Nantes
France Hôpital Necker Paris
France Hôpital Pitié-Salpêtrière Paris
France Hôpital Saint-Louis Paris
France CHU Lyon Sud Pierre Benite
France CHU Robert Debré Reims
France Centre Henri Becquerel Rouen
France CHU Purpan Toulouse
France Hôpital Bretonneau Tours
France CHU Brabois Vandoeuvre les Nancy
France Institut Gustave Roussy Villejuif
Italy Ospedale Cuneo Cuneo

Sponsors (1)

Lead Sponsor Collaborator
Lymphoma Study Association

Countries where clinical trial is conducted

France,  Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Predictive value of PET on progression-free survival 2 years
Secondary Comparison of PET results to treatment response (Cheson criteria) 30 weeks
Secondary Correlation of PET data with FLIPI index score Baseline
Secondary Comparison of changes in lymph node volumes measured by CT to changing of FDG fixation 30 weeks
Secondary Correlation of PET data with histopathological data (including the use of immunohistochemical markers) Baseline
Secondary Evaluation of the sensitivity of PET in the detection of the involvement of hematopoietic marrow Baseline
Secondary Comparison of conventional criteria for evaluating the response to the criteria "revised" by the international workshop criteria 30 weeks
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