Author: pm
Date: 2009-05-13

Inclusion Criteria
Patients with histological diagnosis of DLBCL
Aged 18 or above
Not previously treated
Bulky stage IA to IV
WHO performance status 0, 1 and 2
Written informed consent
Access to a registered PET Scanner

PET after 2 cycles
(Substudy of R-CHOP 14 vs 21)
Blinded evaluation of prognostic value of FDG-PET after 2 cycles of chemotherapy in Diffuse Large B-cell Non-Hodgkin’s Lymphoma

R -

To Register patients:
Lymphoma Trials Office, CR UK and UCL Cancer Trials Centre, 90 Tottenham Court Road, London, W1T 4TJ
E-mail: R-CHOP@ctc.ucl.ac.uk, Telephone: 020 7679 9860, Fax No. 020 7679 9861
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Email: watchandwait@ctc.ucl.ac.uk

Available PET centres
Aberdeen
Cheltenham General
Coventry
Guys & St Thomas’
Manchester (WMIC)
Mount Vernon
Nottingham City
Preston
QEH, Birmingham
Royal Marsden
UCLH

C H

O P

Chief Investigator (R-CHOP) : Prof D Cunningham (Royal Marsden Hospital)
Chief Investigator (PET) : Dr G Mikhaeel (St Thomas’ Hospital)

Study Objective
To evaluate the prognostic value of FDG-PET after 2 cycles of chemotherapy in DLBCL.
Does PET predict the final outcome of treatment (response)
Does early CR on PET predict for better prognosis ?
What is the difference in Failure-free survival between PET +ve and -ve patients?
Can response be quantitively assessed with PET?

R-CHOP 21 (cycle repeats every 21 days for 8 cycles)
Rituximab: 375mg/m2 iv day 1
Cyclophosphamide: 750mg/m2 iv day 1
Doxorubicin: 50mg/m2 iv day 1
Vincristine: 1.4mg/m2 iv day 1
Prednisolone: 40mg/m2 po days 1 to 5

All patients have pre-treatment and post 2 cycles PET Scans. Scans are archived centrally and reported in batches. Only the 2nd scan is blinded to the treating clinician. All patients will received R-CHOP 21 as per protocol. The result of the PET Scan will be correlated to treatment outcome.

Sample Size and Accrual
To detect a 25 % difference in Failure-free survival at 2 years between PET –ve and +ve group, with 90% power 200 patients are required
We currently have 99 patients accrued.