Propose: Carbon ion radiotherapy (CIRT) offers the potential advantages of improved dose localization and enhanced biological effect. We examined the effect of CIRT in terms of reducing the rate of local recurrence in patients with locally advanced adenocarcinoma of the pancreas.Methods: Between April 2003 and February 2007, 46 patients with locally advanced pancreas cancer were eligible for this analysis. Patients eligible for study entry had histologically or cytologically confirmed with invasive ductal adenocarcinoma of the pancreas. Eligibility criteria were confirmation of invasive ductal carcinoma by CT findings, age of 80 years or younger, ECOG performance score 0, 1, or 2, and adequate hepatic, renal and cardiopulmonary function sufficient for undergoing surgery. The criteria of the CT findings for non-resectability of the tumor included tumor encasement of the celiac trunk and/or superior mesenteric artery. CIRT was given once daily, 4 days a week, for fixed 12 fractions in 3 weeks. The dose was set at 38.4GyE and escalated to 52.8GyE at 5% increments. Toxicity on organs such as the skin, digestive tract and liver was assessed according to the NCI-CTC classifications. Tumor response was defined by the RECIST scoring system as the maximum tumor response observed during the first 6 months after the initiation of CIRT. Local recurrence was defined in terms of lesions occurring in the tumor bed. Results:All patients completed the scheduled treatment course. Seven grade 3 acute and two grade 3 late toxicities were observed. Six of 7 grade 3 acute toxicities were anorexia and one was cholangitis. Complete response (CR) was observed in one lesion, partial response (PR) in 7,stable disease (SD) in 37, and progressive disease (PD) was observed in one lesion. The local control rates at one year in the 46 analyzed patients and in the patients receiving 45.6GyE or more were 85% and 95% respectively. The one year overall survival rate were 44% at all patients, and 47% at higher than 45.6GyE respectively. Conclusion:CIRT for locally advanced pancreas cancer seems to be safe and effective, however we could not get sufficient survival benefit. We started a phase I/II clinical trial of gemcitabine combined with CIRT for patients with locally advanced pancreas cancer from April 2007. At present we are trying to give 1000mg/m2 combined with 48GyE of carbon ion. All patients completed the scheduled treatment course with no major toxicity. This trial is still going.第49回粒子線治療世界会
