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Recruiting NCT05841420

Gemcitabine Versus Reduced-dose Combination Chemotherapy in Fragile Patients with Non-resectable Pancreatic Cancer

Phase II Interventional Pancreas Cancer Non-Resectable Pancreas Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Gemcitabine, Nab paclitaxel.
Who it may be relevant to
Registry conditions: Pancreas Cancer, Non-Resectable Pancreas Carcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized Phase II Study of Gemcitabine Versus Reduced-dose Combination Chemotherapy in Fragile Patients with Non-resectable Pancreatic Cancer

Overview

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 pancreatic cancer, who are unfit for full-dose combination chemotherapy. 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.

Detailed description

According to guidelines the recommended treatment for patients with non-resectable pancreatic cancer (PC) is combination chemotherapy, whereas old and/or fragile patients can be offered Gemcitabine monotherapy, if they are fit for treatment. Phase III trials show improved effect of combination chemotherapy compared to Gemcitabine, but these trials were restricted to fit patients younger than 75 years of age, as full-dose combination chemotherapy is more toxic.

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.

Interventions

  • Drug 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
  • Drug Nab paclitaxel
    Nab-Paclitaxel: 100mg/m2 on day 1, 8 and 15 every 4 weeks

Primary outcome measures

  • PFS (Progression Free Survival) [Time frame: 1 year from end of study accrual.]
Secondary outcome measures (5)
  • OS (Overall Survival) [Time frame: 1 year from end of study accrual.]
  • RR (Response rate) [Time frame: 1 year from end of study accrual.]
  • Hospitalizations [Time frame: Through study completion, an average of 6 months.]
  • Quality of Life (QOL) assessed by EORTC QLQ-C30 at baseline and after 8, 16, and 24weeks [Time frame: At baseline and at 8, 16, and 24 weeks.]
  • Cumulative worst toxicity during treatment [Time frame: From date of first treatment until 1 year from end of study treatment.]

Eligibility criteria

Inclusion criteria

  • Age ≥ 18 years
  • 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

  • Patients eligible for downstaging/preoperative chemotherapy followed by resection or local ablation or irradiation
  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Denmark · 1 center
  • Department of Oncology, Aalborg University Hospital — Aalborg

Publications

  • 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. PMID 37328835

Identifiers

NCT: NCT05841420 · DPCG-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗