Full-dose single-agent chemotherapy (gemcitabine) or reduced-dose combination chemotherapy as first palliative treatment for fragile patients with advanced pancreatic cancer.

Phase 1

• Conditions: Pancreatic Cancer; MedDRA version: 21.1Level: LLTClassification code 10033605Term: Pancreatic cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: LLTClassification code 10033606Term: Pancreatic cancer non-resectableSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-005067-52-DK
• Lead Sponsor: Aalborg University Hospital, Department of Oncology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-30
• Last Update Posted: 19 February 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

•Age = 18 years
•Adenocarcinoma of the pancreas, histopathologically or cytologically verified
•Non-resectable (locally advanced or metastatic) pancreatic cancer
•Patients unfit or not candidate for full-dose combination chemotherapy
•Patients eligible for full dose gemcitabine or reduced dose combination chemotherapy
•Performance status = 2
•Measurable or non-measurable disease
•Adequate hematologic function defined as absolute neutrophil count (ANC) = 1.5x109/l and platelets count = 100x109/l within 2 weeks prior to enrollment
•Adequate organ function (bilirubin = 1.5 x UNL (Upper normal limit) and eGFR > 50ml/min within 2 weeks prior to enrollment
•Toxicity of prior chemotherapy, including neurotoxicity, resolved to CTCAE < grade 2
•Oral and written informed consent must be obtained according to the local Ethics committee requirements
•Fertile patients must use adequate contraceptives

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 68

Exclusion Criteria

•Patients eligible for downstaging/preoperative chemotherapy followed by resection or local ablation or irradiation
•Prior chemotherapy for pancreatic cancer (However, patients treated with adjuvant therapy with recurrence occurring more than 6 months after end of this treatment are eligible)
•Concurrent, non-curatively treated malignant neoplasm other than pancreatic adenocarcinoma
•Concurrent treatment with any other anti-cancer therapy
•Pregnant or breast-feeding patients
•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.
•Other condition or therapy, which in the investigator’s opinion may pose a risk to the patient or interfere with the study objectives.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified