Concurrent Helical Tomotherapy With Chemotherapy in Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC)

  • STATUS
    Recruiting
  • participants needed
    30
  • sponsor
    AZ-VUB
Updated on 7 November 2020
measurable disease
carcinoma
serum bilirubin level
chemoradiotherapy
neutrophil count
docetaxel
large cell carcinoma
stage iii non-small cell lung cancer
kidney function test

Summary

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.

Description

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.

Details
Condition Non-Small Cell Lung Cancer
Treatment docetaxel, Cisplatinum, Tomotherapy
Clinical Study IdentifierNCT00379717
SponsorAZ-VUB
Last Modified on7 November 2020

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