|This study will evaluate whether increasing the dose of radiotherapy and/or the addition of nelfinavir to the chemotherapy increases the progression free survival in patients with inoperable cancer of the pancreas that has not spread beyond the pancreas.
The study consists of 2 stages:
Stage 1 – to determine the safe, tolerable dose of nelfinavir to be administered alongside chemoradiotherapy. This will establish the dose of nelfinavir to be taken forward to stage 2.
This will identify an optimum dose of oral nelfinavir in comnbination with capecitabine during radiotherapy, following 4 cycles of GEMABX.
Endpoint – a safe and tolerable dose of nelfinavir to be administered alongside chemoradiotherapy.
1. Does increasing the radiotherapy does schedule improve the 12 months survival rate?
2. Does the addition of nelfinavir to CRT improve progression free survival?
All patients revieve three cycles of GEMABX. Those without progression disease will then be randomised to one of the following arms.
Arm A: Nelfinavir together with chemoradiotherapy
Arm B: Chemoradiotherapy (without nelfinavir)
Arm C: Nelfinavir together with chemoradiotherapy (but using a higher dose of radiotherapy) – this involves 2 more fractions
Arm D: Chemoradiotherapy without nelfinavir (but using a higher dose of radiotherapy) this involves 2 more fractions
Arm E: Chemotherapy alone
Patients not eligible for the study will be treated as per local standard but will be followed up on the study.