BLEOMYCIN for Unresectable pancreatic cancer

Inclusion criteria

• {"criterion_text":"- Age over 18 years (male and female)\n- Written informed consent\n- Histopathological confirmed adenocarcinoma of the pancreas (intraoperative examination possible)\n- Lesion defined as unresectable (infiltration of mesenteric or portal vein exceeding 180 degrees or its thrombosis, infiltration of the hepatic artery, celiac artery or superior mesenteric artery) on abdominal CT/MRI not older than 60 days (stage III), or patients after resection with local recurrence of the neoplastic process\n- Tumor size not larger than 6 cm on a CT/MRI scan not older than 60 days\n- Patients undergoing chemotherapy or patients with a \"de novo\" diagnosis of pancreatic cancer\n- ECOG performance status: 0,1 or 2"}

Exclusion criteria

• {"criterion_text":"- Age under 18 years\n- Inability to give consent in writing\n- Pregnant or lactating women\n- Significant cardiac abnormality (rhythm other than sinus rhythm).\n- Patients with pacemakers or any implanted stimulation device\n- Allergy to contrast media that would compromise the ability to perform imaging after surgery\n- Documented history of allergy to bleomycin\n- Documented history of pulmonary fibrosis\n- Patient with metastatic stage IV disease\n- INR > 1,5 without use of anticoagulants\n- Body temperature >38°C or any infection requiring antibiotic therapy within 24 hours prior to study treatment. 12. Overuse or addiction to alcohol, drugs or any other substances (caffeine and nicotine excluded)\n- Any circumstances, that in the Investigator's judgement may prevent the patient from participating in the study, undergoing the study assessments in accordance with the protocol or bear unjustified risk to the patient"}

Primary endpoints

• {"endpoint_text":"- Progression-free survival (PFS) defined as the time from initiation of study treatment to the first occurrence of disease progression or death from any cause, whichever occurs first.","definition_or_measurement_approach":"Defined as the time from initiation of study treatment to the first occurrence of disease progression or death from any cause, whichever occurs first."}

Secondary endpoints

• {"endpoint_text":"- Patient overall survival (OS) defined as the proportion of patients remaining alive from the initiation of study treatment until the last follow-up visit.","definition_or_measurement_approach":"Defined as the proportion of patients remaining alive from initiation of study treatment until the last follow-up visit."}
• {"endpoint_text":"- Body weight change in predefined timepoints","definition_or_measurement_approach":"Change in body weight measured at predefined timepoints (timepoints described in schedule of assessments)."}
• {"endpoint_text":"- Pain level (VAS scale)","definition_or_measurement_approach":"Pain assessed using the Visual Analog Scale (VAS)."}
• {"endpoint_text":"- Quality of life EORTC QLQ-PAN26 and WHOQOL-BREF","definition_or_measurement_approach":"Quality of life measured using EORTC QLQ-PAN26 and WHOQOL-BREF instruments."}
• {"endpoint_text":"- Exploratory endpoints: 1. Levels of biomarkers (Ca 19-9 in 1,4, 6 days after surgery [+/- 1 day] and during standard follow-up visits) 2. Changes in morphology and biochemistry panel (including but not limited to, albumin, protein, lipase, amylase levels, CRP, procalcitonin) at the timepoints described by schedule of assessments. 3. Progression-free survival (PFS) defined as the time from the diagnosis","definition_or_measurement_approach":"Exploratory biomarker levels (Ca 19-9) measured at days 1, 4, 6 post-surgery (+/-1 day) and during follow-up; morphology and biochemistry panels measured at schedule timepoints; includes a PFS definition referenced from diagnosis in exploratory context."}

Other endpoints

• {"endpoint_text":"- Exploratory endpoints: 1. Levels of biomarkers (Ca 19-9 in 1,4, 6 days after surgery [+/- 1 day] and during standard follow-up visits) 2. Changes in morphology and biochemistry panel (including but not limited to, albumin, protein, lipase, amylase levels, CRP, procalcitonin) at the timepoints described by schedule of assessments. 3. Progression-free survival (PFS) defined as the time from the diagnosis","definition_or_measurement_approach":"Biomarker measurement (Ca 19-9) at specified post-surgery days and follow-up visits; morphology and biochemistry panels measured per schedule of assessments; includes exploratory PFS defined as time from diagnosis (as stated)."}

Poland

Earliest CTIS Part Ii Submission Date

15-07-2024

Latest Decision Or Authorization Date

09-08-2024

Processing Time Days

25

Number Of Sites

1

Number Of Participants

73

Primary sponsor

Full Name

Wroclaw Medical University

Organisation Type

Educational Institution

Country Of Registered Address

Poland

Contract research organisations

Name

Biostat Sp. z o.o.

Responsibilities

sponsorDuties codes: 1,5,8; contact email: esawicka@biostat.com.pl; phone: 530751185

Third parties

• {"country":"Poland","full_name":"Biostat Sp. z o.o.","duties_or_roles":"sponsorDuties codes: 1,5,8; contact email: esawicka@biostat.com.pl; phone: 530751185","organisation_type":"Non-Pharmaceutical company"}