Trial Information

A Phase III Trial Comparing High Versus Standard Dose of Prophylactic Cranial Irradiation (PCI) in Limited Small Cell Lung Cancer Complete Responders

OBJECTIVES:

- Compare high-dose versus standard-dose prophylactic cranial radiotherapy in terms of
the incidence of brain metastases and overall and disease free survival at 2 years in
patients with limited stage small cell lung cancer in complete remission.

- Evaluate the quality of life and late sequelae in this patient population treated with
these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center, age (60 and under vs over 60), and interval between the start of
induction therapy and date of randomization (90 days or less vs 91-180 days vs more than 180
days). Patients are randomized into one of two treatment arms according to the prophylactic
cranial radiotherapy dose.

- Arm I: Patients receive standard-dose prophylactic cranial radiotherapy (10
fractions/12 days).

- Arm II: Patients receive high-dose prophylactic cranial radiotherapy administered over
16 or 24 days based on the choice of their treatment center.

- 18 fractions/24 days (conventional radiotherapy) OR

- 24 fractions/16 days (accelerated hyperfractionated radiotherapy) Patients with
isolated brain failure may undergo further radiotherapy.

Quality of life is assessed prior to randomization, at 6 months, at 1 year, and then
annually thereafter.

Patients are followed at least every 6 months for 2 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 700 patients will be accrued for this study within 3 years.