Non-Small-Cell Lung Carcinoma Clinical Trial
Official title:
Concurrent Helical Tomotherapy With Chemotherapy in Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC): a Phase I/II Trial of Radiation Dose Escalation and Fixed Dose Chemotherapy.
This non-randomized Phase I/II study is designed to determine the maximum tolerated dose
(MTD) of thoracic radiotherapy and concurrent chemotherapy with cisplatin and docetaxel in
patients with LA-NSCLC. All patients will receive weekly administrations of docetaxel 20
mg/m² and cisplatin 20 mg/m2 concurrently with radiotherapy. Radiotherapy will be delivered
using helical tomotherapy in 30 daily fractions over six weeks. Patients should have
recovered fully from induction concurrent chemoradiotherapy before they continue with the
consolidation chemotherapy phase. Patients will be entered in cohorts of at least 5
subjects.
The first cohort of patients will receive 30 fractions of 2Gy in six weeks up to a total
dose of 60Gy. The concurrent chemotherapy starts at day 1 of the radiotherapy and will be
administered 2-4 hours before the radiotherapy.
The radiotherapy fraction size will be escalated to 2.36Gy in three steps.
Dose escalation steps are:
30*2.00Gy = 60.0Gy (BED= 70.8Gy10 NID2= 60.0Gy) 30*2.12Gy = 63.6Gy (BED= 75.9Gy10 NID2=
64.2Gy) 30*2.24Gy = 67.2Gy (BED= 81.5Gy10 NID2= 68.5Gy) 30*2.36Gy = 70.8Gy (BED= 86.3Gy10
NID2= 72.9Gy) If MTD is not reached, protocol modification allowing further escalation can
be considered.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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