A Randomised Phase II Study of Two Regimens of Palliative Chemoradiation Therapy in the Management of Locally Advanced Non Small Cell Lung Cancer
A third of patients with non-small cell lung cancer (NSCLC) present with Stage IIIA or IIIB
disease, which is not amenable to curative resection. Single modality local therapy, either
surgery or radiation, only cures a fraction of such patients.
Radical radiation is not feasible for all patients with unresectable Stage IIIA or IIIB
non-small cell lung cancer, based upon the extent of the loco-regional disease or the
medical state of the patient. Patients of good performance status receiving protracted
high-dose palliative radiotherapy do obtain a survival benefit from this therapy. Studies
have shown a survival advantage by adding chemotherapy to radical radiation therapy: but
studies in the high-dose palliative radiotherapy setting are lacking. Two regimens of
concurrent chemotherapy with high-dose palliative radiotherapy have been developed locally,
with established MTDs. These 2 regimens do warrant a comparative assessment in a phase II
trial, prior to a phase III trial against high dose palliative radiation alone (36Gy/12#/5).
This is a randomised phase II trial comprising of 2 arms for randomization as follows:
Arm A:External beam radiation, 40 Gy/20#/5 per week, Plus concurrent Vinorelbine, IV,
25mg/m2, days 1, 8, 22 and + Cisplatin 20mg/m2, IV, weekly
Arm B:External beam radiation, 30 Gy/15#/5 per week, Plus concurrentGemcitabine, 200mg
(flat dose) IV days 1, 8, 15
An equal number of patients will be randomised to each arm. The randomisation will be
carried out by the Princess Alexandra Trial Centre.
Patients will be assessed at baseline, weekly during treatment, and then at 3 weeks, 6 weeks
and 12 weeks post treatment then 3 monthly thereafter.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate (RECIST criteria)
Final analysis will occur when all have a minimum 1 year follow-up after randomisation. Approx 3 years after start of trial.
Peter MacCallum Cancer Centre, Australia
Australia: Department of Health and Ageing Therapeutic Goods Administration