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Title: 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

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 overallmore » 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.« less

Authors:
 [1];  [2];  [3];  [4];  [5];  [2];  [6];  [7];  [8];  [1];  [9];  [2];  [5]; ; ;  [3];  [10];  [8];  [2];  [10] more »; « less
  1. Guy's & St. Thomas' NHS Trust, King's College London, London (United Kingdom)
  2. Cancer Research UK and UCL Cancer Trials Centre, London (United Kingdom)
  3. Clatterbridge Cancer Centre, Bebington (United Kingdom)
  4. Southampton General Hospital, Southampton (United Kingdom)
  5. Poole Hospital, Poole (United Kingdom)
  6. North Wales Cancer Centre, Rhyl (United Kingdom)
  7. Addenbrookes Hospital, Cambridge (United Kingdom)
  8. Beatson West of Scotland Cancer Centre, Glasgow (United Kingdom)
  9. Royal Surrey County Hospital, Guilford (United Kingdom)
  10. Mount Vernon Hospital, Middlesex (United Kingdom)
Publication Date:
OSTI Identifier:
22648755
Resource Type:
Journal Article
Resource Relation:
Journal Name: International Journal of Radiation Oncology, Biology and Physics; Journal Volume: 95; Journal Issue: 5; Other Information: Copyright (c) 2016 Elsevier Science B.V., Amsterdam, The Netherlands, All rights reserved.; Country of input: International Atomic Energy Agency (IAEA)
Country of Publication:
United States
Language:
English
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; CHEMOTHERAPY; COMBINED THERAPY; ESOPHAGUS; GY RANGE 10-100; LUNGS; NEOPLASMS; PATIENTS; RADIATION DOSES; RADIOTHERAPY; TOXICITY

Citation Formats

Landau, David B., E-mail: david.landau@kcl.ac.uk, Hughes, Laura, Baker, Angela, Bates, Andrew T., Bayne, Michael C., Counsell, Nicholas, Garcia-Alonso, Angel, Harden, Susan V., Hicks, Jonathan D., Hughes, Simon R., Illsley, Marianne C., Khan, Iftekhar, Laurence, Virginia, Malik, Zafar, Mayles, Helen, Mayles, William Philip M., Miles, Elizabeth, Mohammed, Nazia, Ngai, Yenting, Parsons, Emma, and and others. 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. United States: N. p., 2016. Web. doi:10.1016/J.IJROBP.2016.03.031.
Landau, David B., E-mail: david.landau@kcl.ac.uk, Hughes, Laura, Baker, Angela, Bates, Andrew T., Bayne, Michael C., Counsell, Nicholas, Garcia-Alonso, Angel, Harden, Susan V., Hicks, Jonathan D., Hughes, Simon R., Illsley, Marianne C., Khan, Iftekhar, Laurence, Virginia, Malik, Zafar, Mayles, Helen, Mayles, William Philip M., Miles, Elizabeth, Mohammed, Nazia, Ngai, Yenting, Parsons, Emma, & and others. 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. United States. doi:10.1016/J.IJROBP.2016.03.031.
Landau, David B., E-mail: david.landau@kcl.ac.uk, Hughes, Laura, Baker, Angela, Bates, Andrew T., Bayne, Michael C., Counsell, Nicholas, Garcia-Alonso, Angel, Harden, Susan V., Hicks, Jonathan D., Hughes, Simon R., Illsley, Marianne C., Khan, Iftekhar, Laurence, Virginia, Malik, Zafar, Mayles, Helen, Mayles, William Philip M., Miles, Elizabeth, Mohammed, Nazia, Ngai, Yenting, Parsons, Emma, and and others. Mon . "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". United States. doi:10.1016/J.IJROBP.2016.03.031.
@article{osti_22648755,
title = {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},
author = {Landau, David B., E-mail: david.landau@kcl.ac.uk and Hughes, Laura and Baker, Angela and Bates, Andrew T. and Bayne, Michael C. and Counsell, Nicholas and Garcia-Alonso, Angel and Harden, Susan V. and Hicks, Jonathan D. and Hughes, Simon R. and Illsley, Marianne C. and Khan, Iftekhar and Laurence, Virginia and Malik, Zafar and Mayles, Helen and Mayles, William Philip M. and Miles, Elizabeth and Mohammed, Nazia and Ngai, Yenting and Parsons, Emma and and others},
abstractNote = {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.},
doi = {10.1016/J.IJROBP.2016.03.031},
journal = {International Journal of Radiation Oncology, Biology and Physics},
number = 5,
volume = 95,
place = {United States},
year = {Mon Aug 01 00:00:00 EDT 2016},
month = {Mon Aug 01 00:00:00 EDT 2016}
}