Overview

This trial is active, not recruiting.

Condition lymphoma
Treatment positron emission tomography
Sponsor Hospices Civils de Lyon
Start date February 2002
Trial size 80 participants
Trial identifier NCT00169598, 2000.232

Summary

This randomised study aimed at evaluating the medical and economical impact of positron emission tomography (PET) using fluorine-18-fluoro-deoxyglucose (FDG) in the therapeutic prescription in patients with Hodgkin’s lymphoma or with large B and P cell non-Hodgkin’s lymphoma. The median progression free survival, the costs and the quality of life are compared between two groups : Group 1: the results of conventional staging and of the PET are known before stem cell transplantation. Group 2: only the results of conventional staging before stem cell transplantation are known before stem cell transplantation.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic

Primary Outcomes

Measure
The impact of positron emission tomography (PET) using fluorine-18-floro-deoxyglucose (FDG) in the therapeutic prescription in patients with Hodgkin’s lymphoma or with large B and P cell non-Hodgkin’s lymphoma.
time frame:

Secondary Outcomes

Measure
Median progression free survival
time frame:
The positive and negative likelihood- ratios, the positive and negative predictive values
time frame:
The costs
time frame:
The one-year survival rates
time frame:
The quality of life of the patients
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: Age over 18, with Hodgkin’s lymphoma or with large B and P cell non-Hodgkin’s lymphoma, or after a first-line chemotherapy with at least a residual mass or after induction chemotherapy or at progression. Stem cell transplantation would be programmed. Patients were required to give their written informed consent. Exclusion Criteria: Progressive cancer or diagnosed less than 5 years, except cancer in situ of the cervix and basocell skin carcinoma, kidney insufficiency or diabetes. Patients would not be pregnant or lactating

Additional Information

Official title Remission Evaluation Before Intensified Treatment in Lymphoma: Impact of Positron Emission Tomography (PET) Using Fluorine-18-Floro-Deoxyglucose (FDG) in the Therapeutic Prescription. Medico-Economic Randomised Study
Principal investigator Gilles SALLES, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2007.
Information provided to ClinicalTrials.gov by Hospices Civils de Lyon.