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Preoperative chemotherapy, carbon ion therapy, surgery

Preoperative chemotherapy

Preoperative radiotherapy

Francesca Valvo, MD

Direzione medica

Cristina Bono, MSc

Relapses free survival will be evaluated as efficacy of carbon ions radiation therapy released before surgery.

Enrolled subjects will undergo to 3 cycles of Folfirinox before re-evaluation of the lesion. Then, 4D planning and imaging with respiratory gating end rescanning technique will be adopted to calculate the optimal treatment plan to carbon ions radiation therapy: 38.4 Gy\[RBE\] is the prescribed dose to CTV. 4.8 Gy\[RBE\]/fraction will be delivered 4 times a week in two weeks. 4/6 weeks after hadrontherapy, after a CT scan with contrast, patient will undergo to a surgery. After 4/6 weeks, Gemcitabine will be administered for 6 cycles.

Secondary endpoints of the trial are overall survival, resectability rate (operable vs borderline operable), acute toxicity within 3 months, 3-6 months, over 6 months.

The trial enrolls subjects that will receive in order: chemotherapy, carbon ion therapy, followed by surgical resection after 4/6 weeks then adjuvant chemotherapy.

Carbon Ions Radiation Therapy for Resectable or Borderline Resectable Pancreas Adenocarcinoma

Phase II Clinical Study on Resectable or Borderline Resectable Pancreas Adenocarcinoma Preoperative Treatment With Chemotherapy and Carbon Ions Radiation Therapy (Hadrontherapy)

The local progression free survival is measured

the overall survival of enrolled patients is considered

how many surgeries completed according to the procedures and with histopathological margins free from the disease/enrolled patients

Incidence of acute, medium term and late toxicity according to CTCAE v 4.0 grading toxicity

Foundation IRCCS San Matteo Hospital

CNAO National Center of Oncological Hadrontherapy

Principal investigator

Gemcitabine

Pasireotide

Hormones

Hormone Antagonists

Combination Therapy: Dose escalation of SOM 230 LAR and standard treatment with gemcitabine. Treatment will be administered on an outpatient basis. Gemcitabine is administered by IV infusion. The dose should be based on the patient's actual baseline body weight; the dose will be recalculated if there is a weight change of \> 10% from baseline. The dose of gemcitabine will be given over 30 minutes, weekly every 3 weeks followed by 1 week rest period.

SOM 230 LAR will be administered as an intramuscular dose determined by the dosing schema, every month.

We will attempt dose escalation starting at a lower level 1 of 40 mg since we are using SOM 230 LAR in combination with gemcitabine for the first time.

SOM 230 LAR

Fixed dose: 1000mg/m\^2 weekly x3 then 1 week off

Richard Kim, M.D.

The goal of this clinical research study is to learn if the study drug SOM 230 in addition to standard therapy of gemcitabine can shrink or slow the growth of pancreatic cancer. The safety and tolerability of different doses of SOM 230 will also be studied. The participants' physical state, changes in the size of the tumor, and laboratory findings taken while on-study will help us (the study doctor and Moffitt Cancer Center) decide if SOM 230 is safe and effective.

This is a single-arm, open-label, phase I study of combination therapy with SOM 230 LAR and standard treatment with gemcitabine. We will utilize a staggered, sequential dose-escalation design to define the maximum tolerated dose (MTD) of SOM 230 LAR when combined with standard doses of gemcitabine. Cycle will be defined as 28 days.

Treatment will be administered on an outpatient basis. Gemcitabine is administered by IV infusion. The dose should be based on the patient's actual baseline body weight; the dose will be recalculated if there is a weight change of \> 10% from baseline. The dose of gemcitabine will be given over 30 minutes, weekly every 3 weeks followed by 1 week rest period. SOM 230 LAR will be administered as an intramuscular dose determined by the dosing schema, every month.

SOM 230 and Gemcitabine in Advanced Pancreatic Cancer

Phase I Study of Combination of SOM 230 Long Acting Release (LAR) + Gemcitabine in Locally Advanced or Metastatic Pancreatic Cancer

Safety / Tolerability (type, frequency, severity, and relationship of adverse events to study drug)

Frequency counts and percentage will be used to summarize the progression-free survival (PFS) in 3 months period.

Tumor response according to Response Evaluation Criteria in Solid Tumors (RECIST). Objective tumor response will be summarized using frequency counts and percentage.

Frequency counts and percentage will be used to summarize the overall survival (OS) in 6 months period.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Carbon Ions Radiation Therapy for Resectable or Borderline Resectable Pancreas Adenocarcinoma	NCT03822936	Cancer of Pancr... Pancreas Adenoc... Resectable Panc...	Preoperative ch... Preoperative ra...	18 Years - 75 Years	CNAO National Center of Oncological Hadrontherapy
Carbon Ions Radiation Therapy for Resectable or Borderline Resectable Pancreas Adenocarcinoma	NCT03822936	Cancer of Pancr... Pancreas Adenoc... Resectable Panc...	Preoperative ch... Preoperative ra...	18 Years - 75 Years	CNAO National Center of Oncological Hadrontherapy
SOM 230 and Gemcitabine in Advanced Pancreatic Cancer	NCT01385956	Pancreatic Canc...	SOM 230 LAR Gemcitabine	18 Years -	H. Lee Moffitt Cancer Center and Research Institute

Spots Global Cancer Trial Database for exocrine pancreas