Methods |
Randomised controlled trial
Number of centres: 16
Location: France
Years: November 1994 ‐ December 1999
Final analysis
Sponsorship: Schering Laboratories of France
Central pathology review: yes
Definition of Complete Response: disappearance of all documented disease. An unconfirmed complete response was defined by a reduction of at least 70 percent in the largest diameter of all measurable lesions in association with a complete response with respect to all other measures. |
Participants |
Number of patients randomised: 197
Our analysis: 197
Patients untreated: yes
INCLUDED:
Histology: intermediate and high‐grade NHL
IPI: age‐adjusted low, low‐intermediate, high‐intermediate
Age: 15‐60 years
EXCLUDED:
IPI high‐risk |
Interventions |
Control group: CHOP 8 cycles
Experimental group: CEEP 2 cycles, followed by high‐dose MTX and Cytarabine, followed by BEAM and PSCT
Randomization: upfront |
Outcomes |
Overall survival
Event‐free survival
Disease‐free survival
Freedom from progression |
Notes |
source: abstract + personal communication |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |