GEMCITABINE for Pancreatic cancer

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years\n- Toxicity of prior chemotherapy, including neurotoxicity, resolved to CTCAE < grade 2\n- Oral and written informed consent must be obtained according to the local Ethics committee requirements\n- Fertile patients must use adequate contraceptives\n- Adenocarcinoma of the pancreas, histopathologically or cytologically verified\n- Non-resectable (locally advanced or metastatic) PC o\tLocally advanced is defined as both 1) pancreatic cancer confined to the pancreas with direct infiltration of nearby vessels with or without regional lymph node metastases and 2) inoperable (medically or technically) local recurrence of pancreatic cancer with or without regional lymph node metastases. Furthermore, metastatic disease includes peritoneal metastatic disease.\n- Patients unfit or not candidate for full-dose combination chemotherapy\n- Patients eligible for full dose gemcitabine or reduced dose combination chemotherapy\n- Performance status (PS) ≤ 2\n- Measurable or non-measurable disease\n- Adequate hematologic function defined as absolute neutrophil count (ANC) ≥ 1.5x109/l and platelets count ≥ 100x109/l within 2 weeks prior to enrollment\n- Adequate organ function (bilirubin ≤ 1.5 x UNL (Upper normal limit) and eGFR > 30ml/min within 2 weeks prior to enrollment"}

Exclusion criteria

• {"criterion_text":"- Patients eligible for downstaging/preoperative chemotherapy followed by resection or local ablation or irradiation\n- Prior chemotherapy for PC (however, patients treated with adjuvant therapy with recurrence occurring more than 6 months after end of this treatment are eligible)\n- Concurrent, non-curatively treated malignant neoplasm other than pancreatic adenocarcinoma\n- Concurrent treatment with any other anti-cancer therapy\n- Pregnant or breast-feeding patients\n- Patients clearly intending to withdraw from the study if not randomized in the willing arm or patients who cannot be regularly followed up for psychological, social, familiar, or geographic reasons.\n- Other condition or therapy, which in the investigator’s opinion may pose a risk to the patient or interfere with the study objectives.\n- Known allergy or intolerance to any of the drugs used in DPCG-01 (gemcitabine or nab-paclixatel)"}

Primary endpoints

• {"endpoint_text":"- Progression Free Survival (PFS)","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Overall Survival (OS)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Response rate","definition_or_measurement_approach":""}
• {"endpoint_text":"- Number of hospitalizations during treatment","definition_or_measurement_approach":""}
• {"endpoint_text":"- Quality of life assessed by EORTC QLQ-C30 at baseline and after 8, 16, and 24weeks","definition_or_measurement_approach":"Measured using EORTC QLQ-C30 at baseline and at weeks 8, 16, and 24"}
• {"endpoint_text":"- Cumulative worst toxicity during treatment (Adverse events ≥ grade 3 according to CTCAE version 5.0)","definition_or_measurement_approach":"Adverse events graded by CTCAE version 5.0; cumulative worst toxicity defined as AEs ≥ grade 3"}

Denmark

Earliest CTIS Part Ii Submission Date

22-08-2024

Latest Decision Or Authorization Date

04-02-2025

Processing Time Days

166

Number Of Sites

7

Number Of Participants

96

Primary sponsor

Full Name

Aalborg University Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Aalborg University Hospital","duties_or_roles":"code 1","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Denmark","full_name":"Odense University Hospital","duties_or_roles":"code 7","organisation_type":"Hospital/Clinic/Other health care facility"}