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

Sponsor

Lymphoma Study Association (Other)

Overall Status

Completed

CT.gov ID

NCT00915096

Collaborator

(none)

121

Enrollment

Locations

64.7

Actual Duration (Months)

5.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma, Follicular

Study Design

Study Type:

Observational

Actual Enrollment :

121 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

High Tumor Burden Follicular Lymphoma: Impact of [18F]-FDG Positron Emission Tomography (PET) in the Assessment of Treatment Response

Actual Study Start Date :

Sep 18, 2007

Actual Primary Completion Date :

May 10, 2011

Actual Study Completion Date :

Feb 8, 2013

Arms and Interventions

Arm	Intervention/Treatment
High Tumor Burden Follicular Lymphoma

Outcome Measures

Primary Outcome Measures

Predictive value of PET on progression-free survival [2 years]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CHU - Besançon	Besançon	France
2	CHU Avicenne	Bobigny	France
3	Centre Bergognié	Bordeaux	France
4	Hôpital Henri Mondor	Créteil	France
5	CHU de Dijon	Dijon	France	21034
6	Clinique Victor Hugo	Le Mans	France
7	Centre Hospitalier - Lens	Lens	France
8	CHRU Lille	Lille	France	59037
9	CHU - Limoges	Limoges	France
10	Centre Paoli-Calmettes	Marseille	France
11	CHU - Nantes	Nantes	France
12	Hôpital Necker	Paris	France
13	Hôpital Pitié-Salpêtrière	Paris	France
14	Hôpital Saint-Louis	Paris	France
15	CHU Lyon Sud	Pierre Benite	France	69310
16	CHU Robert Debré	Reims	France
17	Centre Henri Becquerel	Rouen	France	76038
18	CHU Purpan	Toulouse	France
19	Hôpital Bretonneau	Tours	France
20	CHU Brabois	Vandoeuvre les Nancy	France	54511
21	Institut Gustave Roussy	Villejuif	France
22	Ospedale Cuneo	Cuneo	Italy