Landau, DB, Hughes, L, Baker, A, Bates, AT, Bayne, MC, Counsell, N, Garcia-Alonso, A, Harden, SV, Hicks, JD, Hughes, SR et al (show 14 more authors)
(2016)
IDEAL-CRT: A Phase 1/2 Trial of Isotoxic Dose-Escalated Radiation Therapy and Concurrent Chemotherapy in Patients With Stage II/III Non-Small Cell Lung Cancer.
INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS, 95 (5).
pp. 1367-1377.
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IDEAL-CRT: A Phase 1/2 Trial of Isotoxic Dose-Escalated Radiation Therapy and Concurrent Chemotherapy in Patients With Stage II/III Non-Small Cell Lung Cancer.pdf - Published version Download (851kB) |
Abstract
Purpose To report toxicity and early survival data for IDEAL-CRT, a trial of dose-escalated concurrent chemoradiotherapy (CRT) for non-small cell lung cancer. Patients and Methods Patients received tumor doses of 63 to 73 Gy in 30 once-daily fractions over 6 weeks with 2 concurrent cycles of cisplatin and vinorelbine. They were assigned to 1 of 2 groups according to esophageal dose. In group 1, tumor doses were determined by an experimental constraint on maximum esophageal dose, which was escalated following a 6 + 6 design from 65 Gy through 68 Gy to 71 Gy, allowing an esophageal maximum tolerated dose to be determined from early and late toxicities. Tumor doses for group 2 patients were determined by other tissue constraints, often lung. Overall survival, progression-free survival, tumor response, and toxicity were evaluated for both groups combined. Results Eight centers recruited 84 patients: 13, 12, and 10, respectively, in the 65-Gy, 68-Gy, and 71-Gy cohorts of group 1; and 49 in group 2. The mean prescribed tumor dose was 67.7 Gy. Five grade 3 esophagitis and 3 grade 3 pneumonitis events were observed across both groups. After 1 fatal esophageal perforation in the 71-Gy cohort, 68 Gy was declared the esophageal maximum tolerated dose. With a median follow-up of 35 months, median overall survival was 36.9 months, and overall survival and progression-free survival were 87.8% and 72.0%, respectively, at 1 year and 68.0% and 48.5% at 2 years. Conclusions IDEAL-CRT achieved significant treatment intensification with acceptable toxicity and promising survival. The isotoxic design allowed the esophageal maximum tolerated dose to be identified from relatively few patients.
Item Type: | Article |
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Uncontrolled Keywords: | Humans, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Radiation Injuries, Neoplasm Staging, Treatment Outcome, Prevalence, Survival Rate, Comorbidity, Dose-Response Relationship, Radiation, Aged, Aged, 80 and over, Middle Aged, Female, Male, Chemoradiotherapy, Drug-Related Side Effects and Adverse Reactions, Dose Fractionation, Radiation |
Depositing User: | Symplectic Admin |
Date Deposited: | 30 Jun 2017 07:59 |
Last Modified: | 19 Jan 2023 07:01 |
DOI: | 10.1016/j.ijrobp.2016.03.031 |
Related URLs: | |
URI: | https://livrepository.liverpool.ac.uk/id/eprint/3008201 |