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Title: A Phase 1 Study of Stereotactic Body Radiation Therapy Dose Escalation for Borderline Resectable Pancreatic Cancer After Modified FOLFIRINOX (NCT01446458)

Abstract

Purpose: A challenge in borderline resectable pancreatic cancer (BRPC) management is the high rate of positive posterior margins (PM). Stereotactic body radiation therapy (SBRT) allows for higher radiation delivery dose with conformity. This study evaluated the maximal tolerated dose with a dose escalation plan level up to 45 Gy using SBRT in BRPC. Methods and Materials: A single-institution, 3 + 3 phase 1 clinical trial design was used to evaluate 4 dose levels of SBRT delivered in 3 fractions to the planning target volume (PTV) with a simultaneous in-field boost (SIB) to the PM. Dose level (DL) 1 was 30 Gy to the PTV, and for dose levels 2 through 4 (DL2-DL4) the dose was 36 Gy. The SIB dose to the PM was 6, 6, 7.5, and 9 Gy for DL-1, DL-2, DL-3, and DL-4, respectively. All patients received 4 treatments of modified FOLFIRINOX (fluorouracil, leucovorin, irinotecan, oxaliplatin) before SBRT. Results: Thirteen patients with a median age of 64 years were enrolled. The median follow-up time was 18 months. The locations of the cancer were head (n=12) and uncinate/neck (n=1). One patient did not undergo SBRT. There were no grade 3 or 4 toxicities. Five patients did not undergo resection because of disease progression (1 local, 4more » distant); 8 had R0 resection in the PM, and 5 of 8 had vessel reconstruction. Two patients had disease downstaged to T1 and T2 from T3 disease. Four patients are still alive, and 3 are disease free. The median overall survival for resected patients was not reached (9.3: not reached). Conclusion: The SBRT dose of 36 Gy with a 9-Gy SIB to the PM (total 45 Gy) delivered in 3 fractions is safe and well tolerated. The dose-limiting toxicity for a 45-Gy dose was not reached, and further dose escalations are needed in future trials.« less

Authors:
;  [1];  [2]; ;  [3];  [1]; ; ;  [4];  [2];  [1]
  1. Department of Hematology and Oncology, Winship Cancer Institute, Emory University, Atlanta, Georgia (United States)
  2. Department of Radiation Oncology, Winship Cancer Institute, Emory University, Atlanta, Georgia (United States)
  3. Department of Biostatistics, Winship Cancer Institute, Emory University, Atlanta, Georgia (United States)
  4. Department of Surgery, Winship Cancer Institute, Emory University, Atlanta, Georgia (United States)
Publication Date:
OSTI Identifier:
22645644
Resource Type:
Journal Article
Resource Relation:
Journal Name: International Journal of Radiation Oncology, Biology and Physics; Journal Volume: 96; Journal Issue: 2; 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; CITROVORUM FACTOR; CLINICAL TRIALS; GY RANGE 01-10; GY RANGE 10-100; NEOPLASMS; PANCREAS; PATIENTS; RADIATION DOSES; RADIOTHERAPY

Citation Formats

Shaib, Walid L., Hawk, Natalyn, Cassidy, Richard J., Chen, Zhengjia, Zhang, Chao, Brutcher, Edith, Kooby, David, Maithel, Shishir K., Sarmiento, Juan M., Landry, Jerome, and El-Rayes, Bassel F., E-mail: bassel.el-rayes@emoryhealthcare.org. A Phase 1 Study of Stereotactic Body Radiation Therapy Dose Escalation for Borderline Resectable Pancreatic Cancer After Modified FOLFIRINOX (NCT01446458). United States: N. p., 2016. Web. doi:10.1016/J.IJROBP.2016.05.010.
Shaib, Walid L., Hawk, Natalyn, Cassidy, Richard J., Chen, Zhengjia, Zhang, Chao, Brutcher, Edith, Kooby, David, Maithel, Shishir K., Sarmiento, Juan M., Landry, Jerome, & El-Rayes, Bassel F., E-mail: bassel.el-rayes@emoryhealthcare.org. A Phase 1 Study of Stereotactic Body Radiation Therapy Dose Escalation for Borderline Resectable Pancreatic Cancer After Modified FOLFIRINOX (NCT01446458). United States. doi:10.1016/J.IJROBP.2016.05.010.
Shaib, Walid L., Hawk, Natalyn, Cassidy, Richard J., Chen, Zhengjia, Zhang, Chao, Brutcher, Edith, Kooby, David, Maithel, Shishir K., Sarmiento, Juan M., Landry, Jerome, and El-Rayes, Bassel F., E-mail: bassel.el-rayes@emoryhealthcare.org. Sat . "A Phase 1 Study of Stereotactic Body Radiation Therapy Dose Escalation for Borderline Resectable Pancreatic Cancer After Modified FOLFIRINOX (NCT01446458)". United States. doi:10.1016/J.IJROBP.2016.05.010.
@article{osti_22645644,
title = {A Phase 1 Study of Stereotactic Body Radiation Therapy Dose Escalation for Borderline Resectable Pancreatic Cancer After Modified FOLFIRINOX (NCT01446458)},
author = {Shaib, Walid L. and Hawk, Natalyn and Cassidy, Richard J. and Chen, Zhengjia and Zhang, Chao and Brutcher, Edith and Kooby, David and Maithel, Shishir K. and Sarmiento, Juan M. and Landry, Jerome and El-Rayes, Bassel F., E-mail: bassel.el-rayes@emoryhealthcare.org},
abstractNote = {Purpose: A challenge in borderline resectable pancreatic cancer (BRPC) management is the high rate of positive posterior margins (PM). Stereotactic body radiation therapy (SBRT) allows for higher radiation delivery dose with conformity. This study evaluated the maximal tolerated dose with a dose escalation plan level up to 45 Gy using SBRT in BRPC. Methods and Materials: A single-institution, 3 + 3 phase 1 clinical trial design was used to evaluate 4 dose levels of SBRT delivered in 3 fractions to the planning target volume (PTV) with a simultaneous in-field boost (SIB) to the PM. Dose level (DL) 1 was 30 Gy to the PTV, and for dose levels 2 through 4 (DL2-DL4) the dose was 36 Gy. The SIB dose to the PM was 6, 6, 7.5, and 9 Gy for DL-1, DL-2, DL-3, and DL-4, respectively. All patients received 4 treatments of modified FOLFIRINOX (fluorouracil, leucovorin, irinotecan, oxaliplatin) before SBRT. Results: Thirteen patients with a median age of 64 years were enrolled. The median follow-up time was 18 months. The locations of the cancer were head (n=12) and uncinate/neck (n=1). One patient did not undergo SBRT. There were no grade 3 or 4 toxicities. Five patients did not undergo resection because of disease progression (1 local, 4 distant); 8 had R0 resection in the PM, and 5 of 8 had vessel reconstruction. Two patients had disease downstaged to T1 and T2 from T3 disease. Four patients are still alive, and 3 are disease free. The median overall survival for resected patients was not reached (9.3: not reached). Conclusion: The SBRT dose of 36 Gy with a 9-Gy SIB to the PM (total 45 Gy) delivered in 3 fractions is safe and well tolerated. The dose-limiting toxicity for a 45-Gy dose was not reached, and further dose escalations are needed in future trials.},
doi = {10.1016/J.IJROBP.2016.05.010},
journal = {International Journal of Radiation Oncology, Biology and Physics},
number = 2,
volume = 96,
place = {United States},
year = {Sat Oct 01 00:00:00 EDT 2016},
month = {Sat Oct 01 00:00:00 EDT 2016}
}