Trial Information

Concurrent and Non-concurrent Chemo-radiotherapy or Radiotherapy Alone With IMRT for Stage I-III Non-small Cell Lung Cancer to an Individualised MLD

Eligible patients (see below) will receive radiotherapy to the primary tumor and the
initially involved mediastinal lymph nodes to an MLD (Mean Lung Dose) of 20 +/-1Gy,
irrespective of lung function.

Other dose-constraints: spinal cord max: 54Gy, brachial plexus (Dmax):66Gy

In concurrence with chemotherapy, radiotherapy will be delivered as follows:

- First three weeks/30 fractions: twice-daily fractions of 1.5Gy, with 8h to 10h as
interfraction interval, 5 days per week. Total dose: 45Gy/30 fractions

- Thereafter: once daily fractions of 2.0Gy, 5 days per week until the target dose has
been reached.

In sequential or radiotherapy alone schedules, twice-daily 1.8Gy with an interfraction
interval of at least 8h will be delivered.

The radiation doses will be specified according to ICRU 50. Lung density corrections will be
applied, as well as all standard QA procedures. Technical requirements are the same as in
standard practice at MAASTRO clinic

Chemotherapy schedules allowed:

1. 1-2 cycles induction chemotherapy: any third generation schedule is allowed. The type
will be registered.

2. Concurrent part: (day 1 = first day of radiotherapy)

- cisplatin - vinorelbine

- cisplatin - docetaxel

- cisplatin - etoposide

- cisplatin - pemetrexed in non-squamous histologies Q 3 weeks; 3 cycles

When the calculated creatinin clearance is less than 60ml/min, cisplatin may be substituted
for carboplatin