A Randomized Phase 3 Trial of Carbon Ion versus Conventional Photon Radiation Therapy for Locally Advanced, Unresectable Pancreatic

JRCT ID: jRCTs032180179

Registered date:05/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: pancreatic cancer
• Date of first enrollment: 03/08/2017
• Target sample size: 110
• Countries of recruitment: USA,Japan,Italy,Japan,China,Japan,Korea,Japan
• Study type: Interventional

Intervention(s)

Carbon-ion 55.2Gy(RBE)/12fraction/3weeks+
Gemcitabine 1000mg/m2 X 3times

Outcome(s)

• Primary Outcome: overall survival
• Secondary Outcome: progression-free survival, cumulative incidences of locoregional and distant recurrence , quality of life, toxicity, quality-adjusted survival

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. All patients must be willing and capable to provide informed consent within the 30 days prior to registration to participate in the protocol.
2.Histological and/or cytological diagnosis of pancreas adenocarcinoma must be done at any point prior to registration.
3.Unresectable by radiographic or exploration within 30 days of registration.
4.Age >= 18 years.
5.Distance from the pancreas tumor edge to the bowel and stomach >= 3 mm.
6.Tumor does not exceed 15 cm in greatest dimension.
7.No evidence for metastatic disease as assessed by CT imaging of the chest, abdomen and pelvis OR by PET-CT within the 30 days prior to registration.Pancreas-protocol CT or magnetic resonance imaging (MRI) with gadolinium (for patients who cannot receive CT contrast) is required as part of this evaluation.
8.Zubrod performance status of 0-1, within 30 days prior to registration.
9.Adequate hematologic, renal, and liver function as defined by:
Absolute neutrophil count >= 1500 cells/mm3
Creatinine <1.5 mg/dL
Hemoglobin >=8.0 g/dL
AST and ALT < 2.5 X ULN
Bilirubin =< 1.5 times the ULN (after stent placement, if necessary)
10.Patients must complete all required pretreatment evaluations.
11.Able to travel to a foreign country within approximately 4 weeks of randomization (for patients enrolled outside of Japan and Italy)
12.If a patient receives 1 or 2 cycles of chemotherapy at an outside facility, pre-treatment laboratory values must meet the above criteria. If the protocol-compliant imaging had not been obtained prior to chemotherapy, they may be performed prior to registration and any additional chemotherapy being infused.
Women of childbearing potential and male participants must agree to use an effective method of contraception.
13.Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

Exclude criteria

1.Subjects receiving other investigational agents.
2.History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine or nab-paclitaxel or other agents used in study.
3.Subjects who are pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
4.Prior radiation to the upper abdomen
5.Placement of a metal stent for relief of biliary obstruction (metal stents may be placed following completion of radiation therapy).
6.Body weight >100 kg
7.Active inflammatory bowel disease or active gastric/duodenal ulcer
8.Metal implants in the upper abdomen
9.Expected medical intolerance of radiotherapy, concurrent chemotherapy, and/or adjuvant chemotherapy.
10.History of HIV or hepatitis B or C

Related Information

• Primary Sponsor: Yamada Shigeru
• Secondary Sponsor: University of Texas Southwestern Medical Center
• Secondary ID(s): UMIN000028626