Clinical trial · Interventional
A Study of Chemoradiotherapy Using Gem Plus Nab-paclitaxel for Pancreatic Cancer
A Phase I Study of Chemoradiotherapy Using Gemcitabine Plus Nab-paclitaxel for Unresectable Locally Advanced Pancreatic Adenocarcinoma
NCT02272738CI-TRIAL-00030459completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the clinical safety and efficacy of Gemcitabine plus nab-Paclitaxel chemoradiotherapy and to determine the Maximal Tolerated Dose (MTD) for unresectable locally advanced pancreatic adenocarcinoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Nab-Paclitaxel | Drug | Nab-paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gemcitabine, Nab-Paclitaxel
- description
- A conformal phase I study using 3 plus 3 method. Chemoradiotherapy while Gemcitabine, Nab-Paclitaxel are administered. Both Gemcitabine and Nab-Paclitaxel are an interventional agents in this arm. Gemcitabine is administered with 30 min intravenous infusion on day 1,8 and 15 every 4 weeks. Nab-Paclitaxel is administered with 30 min intravenous infusion on day 1,8 and 15 every 4 weeks. Radiotherapy (a total dose of 50.4Gy) was delivered in 28 fractions.
- interventionNames
- Drug: Gemcitabine
- Drug: Nab-Paclitaxel
Primary outcomes (1)
- measure
- Number of patients with Adverse Events
- timeFrame
- 1 years
Secondary outcomes (2)
- measure
- Response Rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed advanced pancreatic cancer * Locally advanced pancreatic cancer is defined as the presence of a surgically unresectable tumor(involving the celiac axis or the superior mesenteric artery) * Performance Status:0-1(ECOG) * Patients of age =\>20 and 75\> * White Blood Cell (WBC) \>=3,500/mm3,12,000/mm3, * Neutrophils \>=1,500/mm3, platelets=100,000/mm3, * Hemoglobin \>=9.5 g/dl, * GOT \</=2.0 X Upper Limit Number (ULN), * Glutamate Pyruvate Transaminase (GPT) \</=2.0 X ULN, * Alkaline Phosphatase (ALP) \</=2.0 X ULN, * Total bilirubin \<=1.5mg/dl, * Serum creatinine \<=1.2mg/dl, * Creatinine clearance\>=50 ml/min * arterial O2 pressure (PaO2) \>=70torr or arterial O2 saturation (SpO2) \>=96% * Life expectancy more than 3 months. * Written informed consent. Exclusion Criteria: * Active infection * Lung fibrosis or intestinal pneumonia detectable on chest X-ray and CT * Severe complication (heart disease, cirrhosis, diabetes) * Myocardial infarction within 3 months * Active synchronous or metachronous malignancy * Pregnant or lactation women, or women with known or suspected pregnancy * Symptomatic brain metastasis * History of severe drug allergy * Peripheral neuropathy * Patients who are judged inappropriate for the entry into the study by the investigator
References
Publications (0)
Data not yet available
No reference posted for this study.