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15134 Background: In Japan, most patients with Hepatocellular Carcinoma (HCC) have liver cirrhosis, an advanced hepatic disorder, and they often require repeated therapies owing to the multicentric nature of carcinogenesis in the cirrhotic liver. Therefore, both radical effect and minimal invasiveness are essential for the treatment of HCC. However, there were no therapies satisfying both of these essential requirements for every-sized HCC. The purpose of this trial was to evaluate the safety and efficacy of two-fraction carbon ion radiotherapy (CIRT) for HCC. Methods: Eligibility criteria for this study were as follows: biopsy-proven HCC; recurrent or residual tumor after other ineffective treatments or no indication for any other treatment; no prior radiotherapy for target tumors; hepatic disorder of Child-Pugh grade A or B; Karnofsky performance status of 60–100; no other active cancer; and digestive tract not in contact with clinical target volume. CIRT was administered within dose escalation study of 32.0 to 38.8 cobalt gray equivalent (GyE) in 2 fractions for 2 days. Results: Between April 2004 and August 2006, 40 patients were totally enrolled. All patients had chronic liver diseases of Child-Pugh grade A in 37, B in 3. The median tumor size was 4.7 cm in diameter (2.0 to 6.7 cm). During a median follow-up of 32 months (range, 5–45 months), no hepatic failure resulting from the therapy and no treatment-related death occurred. Incidence of grade 3 early hepatic toxicity according to NCI-CTC ver.2 in the essential valuables concerning hepatic function was 0% in serum-GPT, ALB, prothrombin activity (PT%) and ALP, and 3% in T.BIL. No grade 4 toxicity has occurred. In 94% and 86% out of the patients, Child-Pugh score did not increase by more than 1 point in the early and late phases, respectively. In the lower-dose group (32.0, 33.6, 35.2 GyE: n=18), 2-year local control rate and overall survival rate were 71% and 83%, respectively. In the higher-dose group (37.0, 38.8 GyE: n=22), they were 100% and 90%, respectively. Conclusions: Although 2-fraction carbon ion radiotherapy seems to be safe and effective, and to have a promising potential as a new, radical, and minimally invasive therapeutic option for Hepatocellular Carcinoma, further careful follow-up is needed to confirm it’s clinical efficacy. No significant financial relationships to disclose.

3638 Background: The rate of local recurrence(LR) for rectal cancer ranges from 10 to 40%. Most patients are referred for radiotherapy. Radiotherapy is generally considered palliative treatment. Th...

4124 Background: We reported that the 4-fraction/1-week carbon ion radiotherapy, that had been conducted from April 2001 to February 2003 within a phase II clinical study, appeared to be safe and t...

4090 Background: Both radicality and minimal invasiveness are essential for the treatment of hepatocellular carcinoma (HCC), because in 85% of all patients the condition is associated with liver cirrhosis. Carbon ion radiotherapy is expected to potentially have both the natures because of its excellent dose distribution and its high cytocidal effect resulting from biologically unique characteristics. Methods: Forty-four patients with histologically documented HCC were treated with 4-fraction carbon ion radiotherapy of 52.8 GyE total dose from April 2001 to February 2003. In this report, thirty-six patients with 36 lesions, whose follow-up periods were longer than one year, were the subjects. Fifteen had recurrent tumors (locally: 9, regionally: 6). Six were at Stage I of the disease, 20 at Stage II and 10 at Stage IIIA according to the UICC criteria (Sixth Edition). Child-Pugh grade was A in 28 and B in 8 patients. Mean maximum tumor size was 4.0 (1.2–7.5) cm in diameter. Anti-tumor effect was evaluated b...