Gemcitabine Versus Reduced-dose Combination Chemotherapy in Fragile Patients with Non-resectable Pancreatic Cancer
NCT ID: NCT05841420
Last Updated: 2025-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
98 participants
INTERVENTIONAL
2023-06-12
2025-06-30
Brief Summary
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The patients will be equally randomized to arm A or arm B:
Arm A: Full-dose single agent treatment with Gemcitabine 1000 mg/m2 weekly on days 1, 8,and 15 every 4 weeks.
Arm B: Reduced-dose (80%) combination-treatment with Gemcitabine plus Nab-Paclitaxel (Gemcitabine: 800 mg/m2 plus Nab-Paclitaxel: 100 mg/m2 on day 1, 8 and 15 every 4 weeks)
Progression-free survival, overall survival and response rate will be estimated for each group, as well as toxicity and quality of life will be prospectively registered.
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Detailed Description
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Studies in colorectal cancer and a post-hoc analysis of Gemcitabine plus Nab-Paclitaxel in PC suggest that reduced-dose of combination chemotherapy may be more efficient in terms of progression-free survival and less toxic as compared to monotherapy in elderly and/or frail patients, but reduced start-dosing of GemNab is not currently labelled.
Moreover, a recent Danish register-based study showed that more use of combination chemotherapy at oncological departments was associated with improved outcome of patients with PC.
Elderly and frail patients with PC are in great need of better treatment results. Hence, a comparative study of reduced-dose combination chemotherapy is warranted and may be practice changing.
The aim of the study is to compare the efficacy and toxicity of full-dose Gemcitabine and reduced-dose combination chemotherapy in patients with non-resectable PC, who are unfit for full-dose combination chemotherapy.
The study is a national multicenter prospective randomized phase II trial, endorsed by the Danish Pancreas Cancer Group (DPCG). 98 patients with non-resectable PC, unfit for full-dose combination chemotherapy, but eligible for first-line chemotherapy, will be included.
The patients will be equally randomized to arm A or arm B:
Arm A: Full-dose single agent treatment with Gemcitabine 1000 mg/m2 weekly on days 1, 8 and 15 every 4 weeks.
Arm B: Reduced-dose (80%) combination-treatment with GemNab (Gemcitabine: 800 mg/m2 plus Nab-Paclitaxel: 100 mg/m2 on day 1, 8 and 15 every 4 weeks).
Progression-free survival, overall survival and response rate will be estimated for each group, as well as toxicity and quality of life will be prospectively registered.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A: "Full dose single agent strategy"
Gemcitabine monotherapy, 1000 mg/m2 weekly on days 1, 8, and 15 every 4 weeks
Gemcitabine
Gemcitabine monotherapy, 1000 mg/m2 weekly on days 1, 8, and 15 every 4 weeks or gemcitabine: 800 mg/m2 on day 1, 8 and 15 every 4 weeks
B: "Reduced dose (80%) combination-therapy strategy"
Nab-Paclitaxel: 100mg/m2 plus gemcitabine: 800 mg/m2 on day 1, 8 and 15 every 4 weeks
Gemcitabine
Gemcitabine monotherapy, 1000 mg/m2 weekly on days 1, 8, and 15 every 4 weeks or gemcitabine: 800 mg/m2 on day 1, 8 and 15 every 4 weeks
Nab paclitaxel
Nab-Paclitaxel: 100mg/m2 on day 1, 8 and 15 every 4 weeks
Interventions
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Gemcitabine
Gemcitabine monotherapy, 1000 mg/m2 weekly on days 1, 8, and 15 every 4 weeks or gemcitabine: 800 mg/m2 on day 1, 8 and 15 every 4 weeks
Nab paclitaxel
Nab-Paclitaxel: 100mg/m2 on day 1, 8 and 15 every 4 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Adenocarcinoma of the pancreas, histopathologically or cytologically verified
* Non-resectable (locally advanced or metastatic) PC
* Patients unfit or not candidate for full-dose combination chemotherapy
* Patients eligible for full dose gemcitabine or reduced dose combination chemotherapy
* Performance status (PS) ≤2
* Measurable or non-measurable disease
* Adequate hematologic function defined as absolute neutrophil count (ANC) ≥1.5 x 10\^9/l and platelets count ≥100x10\^9/l within 2 weeks prior to enrollment
* Adequate organ function (bilirubin ≤1.5 x UNL (Upper Normal Limit) and eGFR (estimated Glomerular Filtration Rate) \>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
Exclusion Criteria
* Prior chemotherapy for PC (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.
* Known allergy or intolerance to any of the drugs used in DPCG-01 (Gemcitabine, S1 or Nab-Paclitaxel)
18 Years
ALL
No
Sponsors
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Aarhus University Hospital
OTHER
Odense University Hospital
OTHER
Herlev and Gentofte Hospital
OTHER
Gødstrup Hospital
OTHER
Vejle Hospital
OTHER
Morten Ladekarl
OTHER
Responsible Party
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Morten Ladekarl
Professor, MD, Phd
Principal Investigators
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Morten Ladekarl, Professor
Role: PRINCIPAL_INVESTIGATOR
Aalborg Universitets Hospital, Department of Oncology
Locations
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Department of Oncology, Aalborg University Hospital
Aalborg, , Denmark
Countries
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Central Contacts
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Facility Contacts
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References
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Rasmussen LS, Winther SB, Chen IM, Weber B, Ventzel L, Liposits G, Johansen JS, Detlefsen S, Egendal I, Shim S, Christensen S, Pfeiffer P, Ladekarl M. A randomized phase II study of full dose gemcitabine versus reduced dose gemcitabine and nab-paclitaxel in vulnerable patients with non-resectable pancreatic cancer (DPCG-01). BMC Cancer. 2023 Jun 16;23(1):552. doi: 10.1186/s12885-023-11035-6.
Other Identifiers
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DPCG-01
Identifier Type: -
Identifier Source: org_study_id
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