Clinical trial • Phase II • Oncology
Fluorouracil for Resectable pancreatic head cancer
Phase II trial of Fluorouracil for Resectable pancreatic head cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Resectable pancreatic head cancer
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 09-10-2024
- First CTIS Authorization Date
- 11-11-2024
Trial design
Randomised, neoadjuvant folfirinox (combination chemotherapy with oxaliplatin, irinotecan, calcium folinate, fluorouracil) versus upfront surgery; doses and schedules not specified in the ctis record.-controlled Phase II trial across 11 sites in Sweden, Norway.
- Randomised
- Yes
- Comparator
- Neoadjuvant FOLFIRINOX (combination chemotherapy with oxaliplatin, irinotecan, calcium folinate, fluorouracil) versus upfront surgery; doses and schedules not specified in the CTIS record.
- Target Sample Size
- 131
Eligibility
Recruits 131 Vulnerable population not selected; written informed consent required. No assent procedures described..
- Pregnancy Exclusion
- Female patients in child bearing age not using adequate contraception, pregnant or lactating women
- Vulnerable Population
- Vulnerable population not selected; written informed consent required. No assent procedures described.
Inclusion criteria
- {"criterion_text":"- Resectable tumour of the pancreatic head radiologically strongly suspect of pancreatic adenocarcinoma\n- T1-3, Nx, M0 (UICC 7th version, 2010)\n- Age > 18 year and considered fit for major surgery\n- Written informed consent\n- Considered able to receive the study specific chemotherapy"}
Exclusion criteria
- {"criterion_text":"- Co-morbidity precluding pancreatoduodenectomy\n- Mental or organic disorders which could interfere with informed consent or treatments\n- Other malignancy within the past 5 years, except non-melanomatous skin or non-invasive cervical cancer\n- Percutaneous tumor biopsy\n- Any reason why, in the opinion of the investigator, the patient should not participate\n- Sensitivity to any of the study medications or any of the ingredients or excipients of these medications\n- Chronic neuropathy ≥ grade 2\n- WHO performance score ≥ 2\n- Granulocyte count < 1500 per cubic millimetre (< 1,5 x 109/L)\n- Platelet count < 100 000 per cubic millimetre (< 100 x 109/L)\n- Serum creatinine > 1.5 UNL (upper limit normal range)\n- Albumin < 2,5 g/dl (< 25 g/L)\n- Female patients in child bearing age not using adequate contraception, pregnant or lactating women"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Overall survival at 18 months after the date of randomisation","definition_or_measurement_approach":"Overall survival measured at 18 months after date of randomisation."}
Secondary endpoints
- {"endpoint_text":"- Progression-free survival assessed at both 18 months and as time since randomisation,","definition_or_measurement_approach":"Progression-free survival measured at 18 months and as time from randomisation to progression."}
- {"endpoint_text":"- Overall mortality at 1 year after commencement of allocated treatment for patients who ultimately underwent resection","definition_or_measurement_approach":"Overall mortality at 1 year after start of allocated treatment for patients who underwent resection."}
- {"endpoint_text":"- Overall survival in both the intention-to-treat (ITT) and per-protocol populations","definition_or_measurement_approach":"Overall survival analysed in ITT and per-protocol populations."}
- {"endpoint_text":"- Overall survival and overall survival following resection","definition_or_measurement_approach":"Overall survival overall and specifically following surgical resection."}
- {"endpoint_text":"- Histopathological response (R0 resection and [y]pN0 disease)","definition_or_measurement_approach":"Histopathological response assessed by R0 resection status and ypN0 disease."}
- {"endpoint_text":"- Compliication rates at 90 days after surgery","definition_or_measurement_approach":"Complication rates (surgical/postoperative) evaluated at 90 days post-surgery."}
- {"endpoint_text":"- Feasibility of neoadjuvant and adjuvant chemotherapy (as assessed by adverse events, dose reductions, and dose delays),","definition_or_measurement_approach":"Feasibility assessed by adverse events, frequency of dose reductions and dose delays for neoadjuvant/adjuvant chemotherapy."}
- {"endpoint_text":"- Completion rates of all parts of multimodal treatment","definition_or_measurement_approach":"Proportion of patients completing all planned parts of multimodal treatment."}
- {"endpoint_text":"- Health economics","definition_or_measurement_approach":"Health economic outcomes (methods not specified in record)."}
- {"endpoint_text":"- Quality of life","definition_or_measurement_approach":"Quality of life outcomes (measurement approach not specified in record)."}
Recruitment
- Planned Sample Size
- 131
- Recruitment Window Months
- 166
- Consent Approach
- Written informed consent required. Subject information and informed consent forms available (documents titled 'L1_SIS and ICF' for Sweden and Norway). No assent or age-specific consent procedures described in the record.
Geography
- Total Number Of Sites
- 11
- Total Number Of Participants
- 131
Sweden
- Earliest CTIS Part Ii Submission Date
- 30-10-2024
- Latest Decision Or Authorization Date
- 11-11-2024
- Processing Time Days
- 12
- Number Of Sites
- 5
- Number Of Participants
- 71
Sites
- Site Name
- Norrlands Universitetssjukhus
- Department Name
- Department of Surgical and Perioperative Sciences, Surgery
- Principal Investigator Name
- Oskar Hemmingsson
- Principal Investigator Email
- oskar.hemmingsson@umu.se
- Contact Person Name
- Oskar Hemmingsson
- Contact Person Email
- oskar.hemmingsson@umu.se
- Site Name
- University of Gothenburg and Sahlgrenska University Hospital (SU)
- Department Name
- Department of Surgery
- Principal Investigator Name
- Svein Olav Bratlie
- Principal Investigator Email
- svein.olav.bratlie@vgregion.se
- Contact Person Name
- Svein Olav Bratlie
- Contact Person Email
- svein.olav.bratlie@vgregion.se
- Site Name
- Karolinska University Hospital
- Department Name
- Division of Surgery and Oncology, Department of Clinical Science
- Principal Investigator Name
- Ernesto Sparrelid
- Principal Investigator Email
- ernesto.sparrelid@ki.se
- Contact Person Name
- Ernesto Sparrelid
- Contact Person Email
- ernesto.sparrelid@ki.se
- Site Name
- Linkopings Universitet
- Department Name
- Department of Surgery and Department of Biomedical and Clinical Sciences
- Principal Investigator Name
- Bergtor Björnsson
- Principal Investigator Email
- bergthor.bjornsson@liu.se
- Contact Person Name
- Bergtor Björnsson
- Contact Person Email
- bergthor.bjornsson@liu.se
- Site Name
- Skåne University Hospital
- Department Name
- Department of Clinical Sciences Lund, Surgery
- Principal Investigator Name
- Bobby Tingstedt
- Principal Investigator Email
- bobby.tingstedt@med.lu.se
- Contact Person Name
- Bobby Tingstedt
- Contact Person Email
- bobby.tingstedt@med.lu.se
Norway
- Earliest CTIS Part Ii Submission Date
- 30-10-2024
- Latest Decision Or Authorization Date
- 12-11-2024
- Processing Time Days
- 13
- Number Of Sites
- 6
- Number Of Participants
- 60
Sites
- Site Name
- Universitetssykehuset Nord-Norge HF
- Department Name
- Department of Gastrointestinal Surgery
- Principal Investigator Name
- Kim Mortensen
- Principal Investigator Email
- Kim.Erlend.Mortensen@unn.no
- Contact Person Name
- Kim Mortensen
- Contact Person Email
- Kim.Erlend.Mortensen@unn.no
- Site Name
- St. Olavs Hospital HF
- Department Name
- Department of Gastrointestinal Surgery
- Principal Investigator Name
- Jon Erik Grønbech
- Principal Investigator Email
- jon.e.gronbech@ntnu.no
- Contact Person Name
- Jon Erik Grønbech
- Contact Person Email
- jon.e.gronbech@ntnu.no
- Site Name
- Helse Stavanger HF
- Department Name
- Department of Gastrointestinal Surgery
- Principal Investigator Name
- Jon Arne Søreide
- Principal Investigator Email
- jonarne.soreide@uib.no
- Contact Person Name
- Jon Arne Søreide
- Contact Person Email
- jonarne.soreide@uib.no
- Site Name
- Haukeland University Hospital
- Department Name
- Department of Gastrointestinal Surgery
- Principal Investigator Name
- Dag Hoem
- Principal Investigator Email
- dag.hoem@helse-bergen.no
- Contact Person Name
- Dag Hoem
- Contact Person Email
- dag.hoem@helse-bergen.no
- Site Name
- Oslo University Hospital HF
- Department Name
- Department of Hepato Pancreato Biliary Surgery
- Principal Investigator Name
- Knut Jørgen Labori
- Principal Investigator Email
- uxknab@ous-hf.no
- Contact Person Name
- Knut Jørgen Labori
- Contact Person Email
- uxknab@ous-hf.no
- Site Name
- Universitetssykehuset Nord-Norge HF (additional entry)
Sponsor
Primary sponsor
- Full Name
- Oslo University Hospital HF
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Norway
Investigational products
- Investigational Product Name
- FLUOROURACIL
- Active Substance
- Fluorouracil
- Modality
- Small molecule
- Routes Of Administration
- INFUSION
- Route
- INFUSION
- Authorisation Status
- 2
- Maximum Dose
- 5280 mg daily; max total 63360 mg
- Investigational Product Name
- GEMCITABINE
- Active Substance
- Gemcitabine hydrochloride
- Modality
- Small molecule
- Routes Of Administration
- INFUSION
- Route
- INFUSION
- Authorisation Status
- 2
- Maximum Dose
- 2200 mg daily; max total 39600 mg
- Investigational Product Name
- IRINOTECAN
- Active Substance
- Irinotecan hydrochloride
- Modality
- Small molecule
- Routes Of Administration
- INFUSION
- Route
- INFUSION
- Authorisation Status
- 2
- Maximum Dose
- 330 mg daily; max total 3960 mg
- Investigational Product Name
- CAPECITABINE
- Active Substance
- Capecitabine
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- 2
- Maximum Dose
- 3652 mg daily; max total 460152 mg
- Investigational Product Name
- OXALIPLATIN
- Active Substance
- Oxaliplatin
- Modality
- Small molecule
- Routes Of Administration
- INFUSION
- Route
- INFUSION
- Authorisation Status
- 2
- Maximum Dose
- 187.5 mg daily; max total 2244 mg
- Investigational Product Name
- CALCIUM FOLINATE
- Active Substance
- Calcium folinate (leucovorin calcium)
- Modality
- Small molecule (vitamin analog)
- Routes Of Administration
- INFUSION
- Route
- INFUSION
- Authorisation Status
- 2
- Maximum Dose
- 880 mg daily; max total 10560 mg
- Combination Treatment
- Yes
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