Preoperative, Proton- Radiotherapy Combined With Chemotherapy for Borderline Resectable Pancreatic Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-14

Study Completion Date

2027-12-31

Brief Summary

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This is an interventional, single arm, open-label, feasibility trial with gemcitabine and nab-paclitaxel, followed by concomitant proton therapy and capecitabine, followed by re-evaluation and surgery (when feasible) for patients with borderline resectable pancreatic cancer.

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Detailed Description

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This is an interventional, single arm, open label, feasibility trial of preoperative chemotherapy + concomitant chemo-proton therapy followed by surgery (when feasible) for patients with borderline resectable pancreatic cancer. Aim of this study is to test referral and enrollment procedures as well as technical feasibility. Proton therapy will be delivered in MedAustron, which is a stand alone facility. Pancreatic cancer patients are typically complex cases that require multidisciplinary care. Moreover delivery of high dose of proton therapy to large volumes including the upper abdomen lymphnodes and pancreatic neural plexus is technically challenging, therefore a feasibility study is deemed necessary. Following this study, a larger study will be performed aiming to confirm the ability of preoperative chemotherapy + concomitant chemo-proton therapy to improve resectability and ultimately outcome of borderline resectable pancreatic cancer without increase in toxicity.

Conditions

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Pancreatic Cancer Proton Therapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a single arm, open-label, feasibility trial with gemcitabine and nab-paclitaxel, followed by concomitant proton therapy and capecitabine, followed by re-evaluation and surgery (when feasible) for patients with borderline resectable pancreatic cancer

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Preoperative, proton- radiotherapy combined with chemotherapy

Patients treated with three cycles of chemotherapy with Nab-PACLitaxel (Abraxane®) (125 mg/m² on day 1, 8, 15; powder for making a infusion solution) and Gemcitabine (1000 mg/m² on day 1, 8, 15; powder for making a infusion solution), followed by concomitant chemotherapy with capecitabine (1.660ml/m² on 5 days per week during the radiation therapy) and proton-therapy (with simultaneous integrated boost (SIB) 50.4 Gy Relative Biological Effectiveness (RBE) and 60.2 Gy (RBE) in 28 fractions of 1.8 Gy (RBE) and 2.15 Gy (RBE) 5 days per week), followed by re-evaluation and surgery

Group Type OTHER

Proton Ions

Intervention Type RADIATION

According to the radiation plan (between 50.4 and a maximum of 60.2 Gy) after Chemotherapy with Nab-PACLitaxel (Abraxane®) + Gemcitabine and concomitant to Capecitabine.

Nab-PACLitaxel

Intervention Type DRUG

Chemotherapy will be delivered upfront for three cycles (week 2-4, week 6-8 and week 10-12) with combined Nab-PACLitaxel (Abraxane®) and Gemcitabine Therapy.

It will be administered as intra venous infusion over 30 minutes.

Gemcitabine

Intervention Type DRUG

Chemotherapy will be delivered upfront for three cycles (week 2-4, week 6-8 and week 10-12) with combined Nab-PACLitaxel (Abraxane®) and Gemcitabine Therapy.

Gemcitabine will also be administered as intra venous infusion over 30 minutes immediately after Nab-PACLitaxel.

Capecitabine

Intervention Type DRUG

Concomitant to proton-radiotherapy (on the same days, within week 14-19)

Surgical resection of the pancreas (when feasible)

Intervention Type PROCEDURE

Pre surgical re-evaluation will be performed at week 21 after enrollment. Patients fulfilling surgery-entry criteria, which consist of no distant metastasis, no massive ascites, no massive pleural effusion, no serious infection, no serious, unresolved chemoradiotherapy related, adverse events and adequate organ system function, will undergo surgery on week 22 (± 1 week). This should be performed via laparotomy.

Interventions

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Proton Ions

According to the radiation plan (between 50.4 and a maximum of 60.2 Gy) after Chemotherapy with Nab-PACLitaxel (Abraxane®) + Gemcitabine and concomitant to Capecitabine.

Intervention Type RADIATION

Nab-PACLitaxel

Chemotherapy will be delivered upfront for three cycles (week 2-4, week 6-8 and week 10-12) with combined Nab-PACLitaxel (Abraxane®) and Gemcitabine Therapy.

It will be administered as intra venous infusion over 30 minutes.

Intervention Type DRUG

Gemcitabine

Chemotherapy will be delivered upfront for three cycles (week 2-4, week 6-8 and week 10-12) with combined Nab-PACLitaxel (Abraxane®) and Gemcitabine Therapy.

Gemcitabine will also be administered as intra venous infusion over 30 minutes immediately after Nab-PACLitaxel.

Intervention Type DRUG

Capecitabine

Concomitant to proton-radiotherapy (on the same days, within week 14-19)

Intervention Type DRUG

Surgical resection of the pancreas (when feasible)

Pre surgical re-evaluation will be performed at week 21 after enrollment. Patients fulfilling surgery-entry criteria, which consist of no distant metastasis, no massive ascites, no massive pleural effusion, no serious infection, no serious, unresolved chemoradiotherapy related, adverse events and adequate organ system function, will undergo surgery on week 22 (± 1 week). This should be performed via laparotomy.

Intervention Type PROCEDURE

Other Intervention Names

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Abraxane®

Eligibility Criteria

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Inclusion Criteria

* Patients with histologically or cytologically confirmed diagnosis of pancreatic cancer
* Diagnosis of borderline resectable cancer according to the international consensus definition 2017.
* Negative staging for distant metastasis
* Blood test within the following limits absolute neutrophil count \> 1,500 cells/mm³, platelet count \> 100,000 cells/mm³, Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) \< 2.5 times the upper limit of normal, total bilirubin \< 2.5 times the upper limit of normal if patient had recent biliary stenting, total bilirubin \< 1.5 times the upper limit of normal if no biliary stenting was done, serum creatinine within normal range (0.6-1.5 mg/dl) with a creatinine clearance \> 30 ml/min (as estimated by Cockroft Gault equation)
* Age \> 18 years
* Karnofsky index ≥ 70
* No tumor infiltration of stomach or duodenum
* The patient is informed of the diagnosis and is able to give informed consent (Ability of subject to understand character and individual consequences of the study protocol)
* Women of fertile age must have adequate conception prevention measures and must not breast feed
* Signed Informed Consent (must be available before study inclusion)

Exclusion Criteria

* Non-exocrine tumors
* Major medical or psychiatric comorbidities that contraindicate radiation therapy, chemotherapy or surgery
* Presence of distant metastasis
* Pregnancy or unwilling to do adequate conception prevention
* Lactating and unwilling to discontinue lactation
* Men of childbearing potential not willing to use effective means of contraception
* Known allergic/hypersensitivity reaction to any of the components of study treatments
* Previous diagnosis of another neoplasm with worse prognosis as compared with the one in this study
* Metallic prosthesis or other condition that prevent an adequate imaging for target volume definition
* Loco-regional conditions that contraindicate radiotherapy e.g. active infections in the area
* Previous abdominal radiotherapy
* Prior systemic treatment for pancreatic cancer
* Hypersensitivity to PACLitaxel, albumin, gemcitabine or to any of the excipients of the chemotherapy
* Severe hepatic impairment
* Baseline Neutrophil Counts \< 1.5 x 10\^9/L
* Baseline Grade ≥ 2 sensory or motor neuropathy
* Patient refusal

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No