Phase I study of preoperative short-course chemoradiation with proton beam therapy and capecitabine for resectable pancreatic ductal adenocarcinoma of the head.
OBJECTIVE
To evaluate the safety of 1 week of chemoradiation with proton beam therapy and capecitabine followed by early surgery.


METHODS
Fifteen patients with localized resectable, pancreatic adenocarcinoma of the head were enrolled from May 2006 to September 2008. Patients received radiation with proton beam. In dose level 1, patients received 3 GyE × 10 (Week 1, Monday-Friday; Week 2, Monday-Friday). Patients in Dose Levels 2 to 4 received 5 GyE × 5 in progressively shortened schedules: level 2 (Week 1, Monday, Wednesday, and Friday; Week 2, Tuesday and Thursday), Level 3 (Week 1, Monday, Tuesday, Thursday, and Friday; Week 2, Monday), Level 4 (Week 1, Monday through Friday). Capecitabine was given as 825 mg/m(2) b.i.d. Weeks 1 and 2 Monday through Friday for a total of 10 days in all dose levels. Surgery was performed 4 to 6 weeks after completion of chemotherapy for Dose Levels 1 to 3 and then after 1 to 3 weeks for Dose Level 4.


RESULTS
Three patients were treated at Dose Levels 1 to 3 and 6 patients at Dose Level 4, which was selected as the MTD. No dose limiting toxicities were observed. Grade 3 toxicity was noted in 4 patients (pain in 1; stent obstruction or infection in 3). Eleven patients underwent resection. Reasons for no resection were metastatic disease (3 patients) and unresectable tumor (1 patient). Mean postsurgical length of stay was 6 days (range, 5-10 days). No unexpected 30-day postoperative complications, including leak or obstruction, were found.


CONCLUSIONS
Preoperative chemoradiation with 1 week of proton beam therapy and capecitabine followed by early surgery is feasible. A Phase II study is underway.
Hong
Theodore S
TS
Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA. tshong1@partners.org
Ryan
David P
DP
Blaszkowsky
Lawrence S
LS
Mamon
Harvey J
HJ
Kwak
Eunice L
EL
Mino-Kenudson
Mari
M
Adams
Judith
J
Yeap
Beow
B
Winrich
Barbara
B
DeLaney
Thomas F
TF
Fernandez-Del Castillo
Carlos
C
D000368:Aged; D000369:Aged, 80 and over; D000069287:Capecitabine; D021441:Carcinoma, Pancreatic Ductal / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery; D003131:Combined Modality Therapy / Q000379:methods; D003561:Cytarabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D005240:Feasibility Studies; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives*; D006801:Humans; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery; D016577:Pancreaticoduodenectomy; D055656:Prescriptions; D011446:Prospective Studies; D061766:Proton Therapy; D011859:Radiography; D011879:Radiotherapy Dosage; D011880:Radiotherapy Planning, Computer-Assisted / Q000379:methods
D003561:Cytarabine; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil