Pancreatic Cancer Clinical Trial
— PARCOfficial title:
Preoperative, Proton- Radiotherapy Combined With Chemotherapy for Borderline Resectable Pancreatic Cancer
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.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Austria | Department of Surgery, LK Wiener Neustadt | Wiener Neustadt | |
Austria | EBG MedAustron GmbH | Wiener Neustadt | Niederösterreich |
Lead Sponsor | Collaborator |
---|---|
EBG MedAustron GmbH | Landesklinkum Wiener Neustadt |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Toxicity - Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 | Incidence of CTCAE version 5.0 Grade 4 non hematological toxicity from enrollment to six months after surgery | from enrollment to six months after surgery | |
Primary | Perioperative Mortality and Complications | Incidence of 90-days-perioperative mortality and incidence of Clavien Dindo Grade III complication rate during hospitalization | 90 days postoperatively | |
Secondary | Toxicity - CTCAE v5.0 | CTCAE V5.0 toxicity from enrollment to six month after surgery | from enrollment to six months after surgery | |
Secondary | Tumor recurrence | local and loco-regional (i.e. in-field) tumor recurrence | 260 weeks after therapy | |
Secondary | Progression free survival | loco-regional progression-free survival | 260 weeks after therapy | |
Secondary | Overall survival | Overall survival | 282 weeks | |
Secondary | Pathologic tumor response | Assessment of pathologic tumor response to pre-operative combined proton- chemotherapy (R0 margin and N0, degree of tumor cell necrosis in the resected tumor specimen) | 260 weeks | |
Secondary | Radiologic response | Assessment of radiologic response of pre-operative chemoradiotherapy. Response to preoperative treatment will be scored with the Japan Pancreas Society (JPS) classification which is a synthesis from the Evans and College of American Pathologists classification (Grade 1: poor or no response to Grade 4: complete response) | 263 weeks after proton therapy | |
Secondary | Quality of Life questionnaire: Functional Assessment of Cancer Therapy - Hepatobiliary (FACT-Hep) | Patient reported Quality of Life (for assessing disease-related symptoms and health-related quality of life). The higher the score the better the Quality of Life. | 282 weeks | |
Secondary | Quality of Life questionnaire: European Organisation for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-30) | Questionnaire developed to assess the quality of life of cancer patients. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / quality of life (QoL) represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems. | 282 weeks | |
Secondary | Quality of Life questionnaire: Brief Pain Inventory | The Brief Pain Inventory (BPI) is a measurement tool for assessing clinical pain.The interference items were now presented with 0-10 scales, with 0=no interference and 10=interferes completely. | 282 weeks |
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