Phase I study of neoadjuvant accelerated short course radiation therapy with photons and capecitabine for resectable pancreatic cancer.
OBJECTIVE
In this phase I study, we sought to determine the feasibility and tolerability of neoadjuvant short course radiotherapy (SC-CRT) delivered with photon RT with concurrent capecitabine for resectable pancreatic adenocarcinoma.


METHODS
Ten patients with localized, resectable pancreatic adenocarcinoma were enrolled from December 2009 to August 2011. In dose level I, patients received 3 Gy × 10. In dose level 2, patients received 5 Gy × 5 (every other day). In dose level 3, patients received 5 Gy × 5 (consecutive days). Capecitabine was given during weeks 1 and 2. Surgery was performed 1-3 weeks after completion of chemotherapy.


RESULTS
With an intended accrual of 12 patients, the study was closed early due to unexpected intraoperative complications. Compared to the companion phase I proton study, patients treated with photons had increased intraoperative RT fibrosis reported by surgeons (27% vs. 63%). Among those undergoing a Whipple resection, increased RT fibrosis translated to an increased mean OR time of 69 min. Dosimetric comparison revealed significantly increased low dose exposure to organs at risk for patients treated with photon RT.


CONCLUSIONS
This phase I experience evaluating the tolerability of neoadjuvant SC-CRT with photon RT closed early due to unexpected intraoperative complications.
Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, United States. Electronic address: jwo@partners.org.
Jennifer Y
JY
Wo
Department of Radiation Oncology, Brigham and Women's Hospital, Harvard Medical School, Boston, United States.
Harvey J
HJ
Mamon
Department of General Surgery, Massachusetts General Hospital, Harvard Medical School, Boston, United States.
Cristina R
CR
Ferrone
Department of Medical Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, United States.
David P
DP
Ryan
Department of Medical Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, United States.
Lawrence S
LS
Blaszkowsky
Department of Medical Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, United States.
Eunice L
EL
Kwak
Harvard Radiation Oncology Program, Boston, United States.
Yolanda D
YD
Tseng
Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, United States.
Brian N
BN
Napolitano
Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, United States.
Marek
M
Ancukiewicz
Department of General Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, United States.
Richard S
RS
Swanson
Department of General Surgery, Massachusetts General Hospital, Harvard Medical School, Boston, United States.
Keith D
KD
Lillemoe
Department of General Surgery, Massachusetts General Hospital, Harvard Medical School, Boston, United States.
Carlos
C
Fernandez-del Castillo
Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, United States.
Theodore S
TS
Hong
D000230:Adenocarcinoma / Q000188:drug therapy / Q000532:radiotherapy / Q000601:surgery; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D000069287:Capecitabine; D059248:Chemoradiotherapy; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004307:Dose-Response Relationship, Radiation; D005260:Female; D005472:Fluorouracil / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D007431:Intraoperative Complications / Q000209:etiology; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery; D017785:Photons / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D011832:Radiation Injuries / Q000209:etiology
D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil
Pancreatic cancer; Short course