CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 98 target
Drug / intervention
Gemcitabine +1 moredrug
Likely dose
Gemcitabine 1000 mg/m2from record
Key inclusion· 11
  • ✓Age ≥18 years
  • ✓Histopathologically or cytologically verified adenocarcinoma of pancreas
  • ✓Non-resectable (locally advanced or metastatic) pancreatic cancer
  • ✓Unfit or not candidate for full-dose combination chemotherapy
Key exclusion· 8
  • ✕Patients eligible for downstaging/preoperative chemotherapy followed by resection, local ablation, or irradiation
  • ✕Prior chemotherapy for pancreatic cancer (except adjuvant with recurrence >6 months after treatment end)
  • ✕Concurrent non-curatively treated malignant neoplasm other than pancreatic adenocarcinoma
  • ✕Concurrent treatment with other anti-cancer therapy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05841420
NCT05841420Phase 2RecruitingUpdate OverdueUpdated 17mo ago · Completion was 13mo ago
Enrollment Stalled
Long Recruiting
Update Overdue
CompareCT.gov

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

Morten Ladekarl·interventional·Posted May 3, 2023·Updated Jan 29, 2025

In Brief

A Phase 2 clinical trial evaluating Gemcitabine and Nab paclitaxel for Pancreas Cancer and Non-Resectable Pancreas Carcinoma. Currently recruiting, targeting 98 participants across 1 site.

Signals

Enrollment appears stalled

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPancreas Cancer, Non-Resectable Pancreas Carcinoma
CountriesDenmark
CollaboratorsAarhus University Hospital, Odense University Hospital, Herlev and Gentofte Hospital, Gødstrup Hospital, Vejle Hospital

Timeline

Phase 2RecruitingOverdue
202420252026
First PostedMay 3, 2023
Enrollment StartJun 12, 2023
Primary CompletionJun 1, 2025
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 3.2 years ago

Interventions

Gemcitabinedrug

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 paclitaxeldrug

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