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
Type of designThis 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 studiedHistologically or cytologically confirmed SCLC with limited disease (Veterans Administration Lung CancerStudy Group) ie patients whose disease can be encompassed within a radical radiation portal. No pleural orpericardial effusions proven to be malignant. RT target volume acceptable by the local radiotherapist. ECOGperformance status 0-2.Concurrent Once-daily versus twice-dailyRadiation therapy: A 2-arm randomized controlled trial ofconcurrent chemo-radiotherapy comparing twice-dailyand once-daily radiation therapy schedules in patients withlimited stage small cell lung cancer (SCLC) and goodperformance status.
Trial interventionsControl 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 withconcurrent BD radiotherapy 45Gy in 30 twice-daily fractions over 3 weeks, 5 days per weekfrom 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 withconcurrent OD radiotherapy 66Gy in 33 daily fractions over 6.5 weeks, 5 days per weekfrom day 22 of cycle 1
Outcome measuresPrimary end-point• Overall survivalSecondary end points• Local progression-free survival• Metastasis-free survival• CTCAE v3.0 toxicity• Chemotherapy dose intensity• Radiotherapy dose intensity
Duration of assessmentPatients will be assessed prior to each cycle of chemotherapy and at 4 weeks after the final cycle. Follow-upwill be at 3 monthly intervals for 12 months and six monthly thereafter until death. Post treatment CT scansthorax and abdomen will be done within 4 weeks of cycle 4 (even if 6 cycles are given) and 6 months afterrandomization.
Data collectionData will be recorded on Case Report Forms (CRFs), a copy should be sent to the Christie Hospital CTU for dataentry and a copy kept at the local centre.
Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.
These resources are provided in partnership with the
Canadian Cancer Society