Early On-therapy PET at First-line Treatment in Diffuse Large B-cell Lymphoma Stage IIB-IV

This study has been completed.
Sponsor:
Collaborator:
Nordic Lymphoma Group
Information provided by:
Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier:
NCT00286832
First received: February 3, 2006
Last updated: July 2, 2011
Last verified: July 2011
  Purpose

Early identification of refractory lymphoma patients provides a basis for stratification between responders to standard approaches and non-responders who may benefit from an early change to an alternative treatment strategy.Metabolic or molecular imaging with fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET) has emerged as a powerful imaging modality for diagnosis, staging, and therapy monitoring of a variety of cancers. The primary hypothesis of the present study is that early response can be pinpointed by PET reflecting both tumor burden and activity, as a surrogate for final outcome. An increasing number of studies have suggested the potential role of 18F-FDG PET in the staging and monitoring of lymphomas. The optimal timing of PET scans and the potential role of quantitative PET using SUV to assess response to chemotherapy remain to be defined. Confirmation of very early 18F-FDG-PET as a significant predictor of treatment response in a homogenous group of aggressive lymphoma patients would potentially change the prognosis of the patient by allowing earlier use of alternative therapies and discontinuation of therapy that will not lead to a significant tumour response.


Condition Intervention Phase
Diffuse Large-Cell Lymphoma
Procedure: PET scan
Phase 3

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Response to Treatment Using 18F-FDG Positron Emission Tomography Imaging (PET) With Special Emphasize on the Prognostic Significance of Early On-therapy PET at First-line Treatment in Diffuse Large B-cell Lymphoma Stage IIB-IV

Resource links provided by NLM:


Further study details as provided by Copenhagen University Hospital at Herlev:

Enrollment: 100
Study Start Date: August 2005
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Single group study Procedure: PET scan
One extra PET scan after 1 cycle of treatment.
Other Name: positron emission tomography

Detailed Description:

Title: Evaluation of response to treatment using 18F-FDG positron emission tomography imaging (PET) in diffuse large B-cell lymphoma stage IIB-IV with special emphasize on the prognostic significance of early on-therapy PET at first-line treatment

Study design: Multicenter trial.

Planned sample size: 100 patients.

Number of centers: Denmark 2; Sweden 1; Norway 1; Finland 1.

Aim of the study: 1. To evaluate the prognostic significance of PET early after treatment initiation. 2. To compare early PET with standard response criteria for NHL and the International Prognostic Index (IPI) in the prediction of response and outcome.

Primary objective: The prognostic significance of FDG-PET after 1 cycle of chemotherapy.

End-points: Progression-free survival (PFS). Overall survival (OS). Response to treatment (standardized response criteria) at mid-treatment and post-treatment.

Inclusion criteria:

Age ≥ 18 years. Newly diagnosed consecutive patients with diffuse large B-cell lymphoma (DLBCL) according to the WHO classification.

Ann Arbor stage IIB-IV. Written informed consent.

Exclusion criteria: Previously treated with chemotherapy or irradiation. Previous malignant diagnosis except basal cell carcinoma and cervical carcinoma in situ.

Pregnancy. Lactation. Diabetes mellitus. Extreme adipositas. Claustrophobia. Active inflammatory disease or infection.

PET-CT evaluation: PET and CT at primary staging before initiation of therapy and PET after one cycle of intravenous chemotherapy (day 10-20) are mandatory. The results of the PET scans are blinded and will not be available for the local physicians. If the PET result is opened, the patient will be excluded from the study.

Only post-treatment PET scans are allowed outside the protocol. The local physician may use post-treatment PET in diagnostic or therapeutic considerations.

Only dedicated full-ring PET scanners are allowed in this study.

Treatment: Therapy with a CHOP-like backbone according to local standards of the individual centers. Treatment according to other protocols allowed.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Community sample according to the area covered by the participating centers

Criteria

Inclusion Criteria:

  • Age ≥ 18 years.
  • Newly diagnosed consecutive patients with diffuse large B-cell lymphoma (DLBCL) according to the WHO classification.
  • Ann Arbor stage IIB-IV.
  • Written informed consent.

Exclusion Criteria:

  • Previously treated with chemotherapy or irradiation.
  • Previous malignant diagnosis except basal cell carcinoma and cervical carcinoma in situ.
  • Pregnancy.
  • Lactation.
  • Diabetes mellitus.
  • Extreme adipositas.
  • Claustrophobia.
  • Active inflammatory disease or infection.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00286832

Locations
Denmark
Department of Hematology, Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Copenhagen University Hospital at Herlev
Nordic Lymphoma Group
Investigators
Principal Investigator: Lars M Pedersen, MD Nordic Lymphoma Group (Large Cell Group)
  More Information

No publications provided

Responsible Party: Lars M Pedersen, MD, Nordic Lymphoma Group (NLG)
ClinicalTrials.gov Identifier: NCT00286832     History of Changes
Other Study ID Numbers: NLG PET Study
Study First Received: February 3, 2006
Last Updated: July 2, 2011
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Copenhagen University Hospital at Herlev:
Non-Hodgkin's lymphoma
Diffuse large B-cell lymphoma
PET
Prognosis

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 23, 2014