Concurrent Once-daily Versus twice-daily Radiation Therapy

Official Title

A 2-arm randomized controlled trial of concurrent chemo-radiotherapy comparing twice-daily and once-daily radiation therapy schedules in patients with limited stage small cell lung cancer (SCLC) and good performance status.

Summary:

Type of design
This is a multicentre randomized phase III trial.
Patients are randomized to one of two treatment arms with 1:1 randomization:
Patients will be randomly allocated to treatment, using a minimization procedure.

Patients studied
Histologically or cytologically confirmed SCLC with limited disease (Veterans Administration Lung Cancer
Study Group) ie patients whose disease can be encompassed within a radical radiation portal. No pleural or
pericardial effusions proven to be malignant. RT target volume acceptable by the local radiotherapist. ECOG
performance status 0-2.

Concurrent Once-daily versus twice-daily
Radiation therapy: A 2-arm randomized controlled trial of
concurrent chemo-radiotherapy comparing twice-daily
and once-daily radiation therapy schedules in patients with
limited stage small cell lung cancer (SCLC) and good
performance status.

Trial Description

Trial interventions
Control Arm:
Four to six cycles of Cisplatin 25 mg/m2 iv D1-3 or 75 mg/m2 D1 Etoposide 100 mg/m2 iv D1-3 with
concurrent BD radiotherapy 45Gy in 30 twice-daily fractions over 3 weeks, 5 days per week
from day 22 of cycle 1

Experimental Arm:
Four to six cycles of Cisplatin 25 mg/m2 iv D1-3 or 75 mg/m2 D1 Etoposide 100 mg/m2 iv D1-3 with
concurrent OD radiotherapy 66Gy in 33 daily fractions over 6.5 weeks, 5 days per week
from day 22 of cycle 1

Outcome measures
Primary end-point
• Overall survival
Secondary end points
• Local progression-free survival
• Metastasis-free survival
• CTCAE v3.0 toxicity
• Chemotherapy dose intensity
• Radiotherapy dose intensity

Duration of assessment
Patients will be assessed prior to each cycle of chemotherapy and at 4 weeks after the final cycle. Follow-up
will be at 3 monthly intervals for 12 months and six monthly thereafter until death. Post treatment CT scans
thorax and abdomen will be done within 4 weeks of cycle 4 (even if 6 cycles are given) and 6 months after
randomization.

Data collection
Data will be recorded on Case Report Forms (CRFs), a copy should be sent to the Christie Hospital CTU for data
entry and a copy kept at the local centre.