Status: Closed
Activation Date: 2008DEC09
Closing Date: 2013JUL22
Phase: III
Description: Concurrent ONce-daily VErsus twice-daily RadioTherapy: A 2-arm randomised controlled trial of concurrent chemo-radiotherapy comparing twice-daily and once-daily radiotherapy schedules in patients with limited stage small cell lung cancer (SCLC) and good performance status
Eligibility: Patients with histologically or cytologically confirmed small cell lung cancer (SCLC). Performance status must be ECOG grade 0-1. Patients with PS 2 whose general condition is explained by obstructive/bulky disease likely to improve after the first cycle of chemotherapy can be included at the discretion of the local investigator.
Objective: Overall survival Local progression-free survival; Metastasis-free survival; CTCAE v3.0 toxicity; Cytotoxic dose intensity; Radiotherapy dose intensity; Prospective cost-effectiveness analysis.
Participation: Open to member centres
Lay Description: 2-arm randomised trial comparing: 45Gy in 30 fractions as a twice daily radiotherapy schedule (given concurrently with cisplatin/etoposide) 66Gy in 33 fractions as a once daily radiotherapy schedule (given concurrently with cisplatin/etoposide)
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Hide Tissue Samples
Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
LUNG | BR28 | 41 | 1 | 1 | 1 |
(Core size is 0.6 mm)
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Fluid SamplesDisease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
LUNG | BR28 | 41 | 1 | 1 |
Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
LUNG | BR28 | 41 | 0 | 0 | 0 | 0 | 4 | 3 | 0 | 0 |