A phase II clinical trial of carbon-ion radiotherapy and concurrent S-1 chemotherapy for locally advanced pancreatic cancer.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. TPS504-TPS504 ◽  
Author(s):  
Makoto Shinoto ◽  
Yoshiyuki Shioyama ◽  
Hiroaki Suefuji ◽  
Akira Matsunobu ◽  
Shingo Toyama ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Clinical Trial ◽  
Phase Ii ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Phase Ii Clinical Trial ◽  
Locally Advanced Pancreatic Cancer ◽  
Carbon Ion Radiotherapy ◽  
Attractive Alternative ◽  
Carbon Ion

TPS504 Background: Despite recent advances in chemotherapy and radiotherapy, prognosis of unresectable locally advanced pancreatic cancer (LAPC) patients remains poor. To improve the outcome, a phase I/II clinical trial of carbon-ion radiotherapy (CIRT) with concurrent gemcitabine for LAPC was started in National Institute of Radiological Sciences in Japan.When compared to photon beams, carbon ion beams offer improved dose distribution, enabling us to concentrate a sufficient dose within a target volume while minimizing the dose in the surrounding radiosensitive normal tissue. In addition, carbon ions being heavier than protons provide a higher biological effectiveness, which increases with depth reaching the maximum at the end of the beam’s range. Although CIRT is expected to offer powerful local effect, whereas the potential risk of distant metastasis represent a critical problem for LAPC. To control distant metastases and subsequently prolong patient survival, a more effective systemic treatment might be essential. Recently, S-1 has shown favorable antitumor activity in several clinical trials for pancreatic cancer. Oral S-1 also has a great clinical advantage because the risks of complications associated with intravenous administration are avoided.We considered oral S-1 to be an attractive alternative to gemcitabine in the CIRT for LAPC. Thus, we planned a phase II clinical trial to evaluate the efficacy and safety of CIRT with concurrent S-1, which is the first trial in the world. Methods: Eligibility included pathological confirmation of pancreatic invasive ductal carcinomas and radiographically unresectable disease without metastasis. Concurrent S-1 is administered orally twice a day at a dose of 80mg/m2/day for 28 days every 6 weeks. Carbon-ion radiotherapy is prescribed with 55.2GyE at 12 fractions in 3 weeks. The primary endpoint is two year overall survival. Clinical trial information: UMIN000013803.

Initial experience of carbon ion radiotherapy for unresectable locally advanced pancreatic cancer

Pancreatology ◽  
2016 ◽  
Vol 16 (4) ◽  
pp. S65-S66
Author(s):  
Makoto Shinoto ◽  
Yoshiyuki Shioyama ◽  
Hiroaki Suefuji ◽  
Akira Matsunobu ◽  
Shingo Toyama ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Locally Advanced Pancreatic Cancer ◽  
Carbon Ion Radiotherapy ◽  
Initial Experience ◽  
Carbon Ion

scholarly journals Effectiveness of Carbon Ion Radiation in Locally Advanced Pancreatic Cancer

2021 ◽  
Vol 11 ◽  
Author(s):  
Jakob Liermann ◽  
Patrick Naumann ◽  
Fabian Weykamp ◽  
Philipp Hoegen ◽  
Juergen Debus ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Local Control ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Progression Free Survival ◽  
Locally Advanced Pancreatic Cancer ◽  
Carbon Ion Radiotherapy ◽  
Free Survival ◽  
Carbon Ion

PurposeEffective treatment strategies for unresectable locally advanced pancreatic cancer (LAPC) patients are eagerly warranted. Recently, convincing oncological outcomes were demonstrated by carbon ion radiotherapy. Nevertheless, there is a lack of evidence for this modern radiation technique due to the limited number of carbon ion facilities worldwide. Here, we analyze feasibility and efficacy of carbon ion radiotherapy in the management of LAPC at Heidelberg Ion Beam Therapy Center (HIT).MethodsBetween 2015 and 2020, 21 LAPC patients were irradiated with carbon ions with a total dose of 48 Gy (RBE) in single doses of 4 Gy (RBE). Three patients (14%) were treated with concomitant chemotherapy with gemcitabine 300 mg/m2 body surface weekly. Toxicity rates were extracted from the charts. Overall survival, progression free survival, local control, and locoregional control were evaluated using Kaplan–Meier estimates.ResultsOne patient developed ascites CTCAE grade III during radiotherapy, which was related to a later histologically confirmed metachronous peritoneal carcinomatosis. No further higher-graded toxicity could be observed. The most common symptoms were nausea and abdominal pain. After a median estimated follow-up time of 19.1 months, the median progression free survival was 3.7 months, and the median overall survival was 11.9 months. The estimated 1-year local control and locoregional control rates were 89 and 84%, respectively.ConclusionCarbon ion radiotherapy of LAPC patients is safely feasible. Local tumor control rates were high. Nevertheless, compared to historical data, an overall survival improvement could not be observed. This could be explained by the poor prognosis of the selected underlying patients that mostly did not respond to prior chemotherapy as well as the early and frequent emergence of distant metastases that demonstrate the necessity of additional chemotherapy in further studies.

Phase I/II trial of carbon-ion radiotherapy with concurrent gemcitabine for patients with locally advanced pancreatic cancer.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e15008-e15008
Author(s):  
Makoto Shinoto ◽  
Shigeru Yamada ◽  
Shigeo Yasuda ◽  
Hiroshi Imada ◽  
Yoshiyuki Shioyama ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Survival Rate ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Locally Advanced Pancreatic Cancer ◽  
Carbon Ion Radiotherapy ◽  
Hematological Toxicity ◽  
High Dose ◽  
Carbon Ion ◽  
Grade 3

e15008 Background: Carbon-ion radiotherapy (CIRT) offers the potential advantage of improved dose localization and enhanced biologic effect. The purpose of this trial was to establish the recommended dose of gemcitabine and CIRT, evaluating the tolerance and efficacy of gemcitabine combined with CIRT for the treatment of the patients with locally advanced pancreatic cancer. Methods: Patients with histopathologically proven, locally advanced pancreatic adenocarcinoma, which involved the celiac trunk or superior mesenteric artery without distant metastasis, were eligible for this trial. The radiation fractions were fixed at 12 fractions in 3 weeks, and the dose of gemcitabine and radiation were gradually increased. First, the dose was fixed at 43.2GyE/8 fractions and the gemcitabine dose was increased from 400, to 700 to 1000mg/m2. Subsequently, the gemcitabine dose was fixed at 1000mg/m2 and the radiation dose was increased from 43.2GyE to 55.2GyE by 5% increments. Gemcitabine was administered for 3 consecutive weeks, once a week. Results: Seventy-five patients were registered from April 2007 through February 2012. Of these patients, 71 were clinically eligible for the study. The most common Grade 3 acute toxicities were hematological toxicity (51%) and anorexia (8%). Dose limiting toxicity developed in three patients: Grade 3 gastric ulcer in 1 and Grade 4 leukopenia in 2. No other serious side effects were found. The two-year local control rate and two-year overall survival rate were 40% and 40% in all patients. The median survival time was 21 months. In the high dose group (n=47), in which patients were irradiated with at least 45.6 GyE, the two-year survival rate was 62%. Conclusions: CIRT was well tolerable even when concomitantly administered with the highest dose of gemcitabine (1000mg/m2).

Local effect and gastrointestinal toxicity for carbon-ion radiotherapy in patients with unresectable locally advanced pancreatic cancer.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 410-410
Author(s):  
Makoto Shinoto ◽  
Yoshiyuki Shioyama ◽  
Hiroaki Suefuji ◽  
Akira Matsunobu ◽  
Shingo Toyama ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Gastric Ulcer ◽  
Fdg Pet ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Local Effect ◽  
Locally Advanced Pancreatic Cancer ◽  
Carbon Ion Radiotherapy ◽  
Carbon Ion ◽  
Gi Toxicity

410 Background: Carbon-ion radiotherapy (CIRT) is a unique external radiotherapy that has an excellent dose conformity and higher biological effectiveness compared to conventional radiotherapy. The sensitivity of the organs in upper abdomen has limited the radiation dose to levels that are ineffective against pancreatic cancer, which has extreme radioresisnatnce. We investigated effectiveness and gastrointestinal (GI) toxicity of CIRT. Methods: From April 2014 to June 2015, 41 patients with pancreatic cancer were treated with definitive CIRT. 26 patients who were confirmed as unresectable locally advanced pancreatic cancer pathologically and by imaging techniques were included in this retrospective analysis. 15 patients were excluded because of resectable disease (n = 3), borderline disease (n = 4), no cell evidence (n = 11). CIRT was performed with 55.2 Gy (RBE) at 12 fractions. The maximal absolute dose with covered 2cm3 of the organ (D2) was restricted under 46 Gy (RBE). All patients were followed up using CT, FDG-PET and upper gastrointestinal endoscopy at least every six months. Anti-tumor effect was evaluated using CT and FDG-PET according to RECIST. If FDG accumulation was negative or equal to normal pancreatic tissue after CIRT, it was defined CR even no decreasing in seize on CT. GI toxicity was evaluated using CTCAE. Results: Tumor location were head in 7, head-body in 2, body-tail in 16. Median tumor size was 35mm (range 21-50). In all patients, sequential and/or concurrent chemotherapy was performed. The median follow-up period was 7.7 months. Local effect using CT criteria was CR in 0, PR in 2, SD in 22, and PD in 2. The evaluation adding FDG-PET criteria was CR in 12, PR in 4, SD in 8, and PD in 2. Two patients who were SD by CT and CR by FDG-PET performed tumor resection and were revealed pCR. The actual incidence of gastric ulcer/bleeding was 15% (n = 4). Only one patient (4%) received blood transfusion because of grade 3 gastric ulcer. The other patients experienced grade 1/2 gastric ulcer. There was no duodenal ulcer. Conclusions: CIRT were effective and well tolerated under the restriction of D2 < 46 Gy (RBE). FDG-PET was useful for the evaluation of local effect after CIRT.

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