CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
Gemcitabine/nab-Paclitaxel +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT02318095
NCT02318095N/ACompleted
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Feasibility Study of Neoadjuvant Gemcitabine/Nab-Paclitaxel and Hypofractionated Image-Guided Intensity Modulated Radiotherapy in Resectable and Borderline Resectable Pancreatic Cancer

Duke University·interventional·Posted Dec 17, 2014·Updated Oct 26, 2023

In Brief

A clinical study evaluating Gemcitabine/nab-Paclitaxel, Radiation therapy, and 2 other interventions for Resectable Pancreatic Cancers. Completed, enrolled 40 participants across 1 site.

Detailed Summary

This research protocol will evaluate the feasibility of administering neoadjuvant gemcitabine and nab-paclitaxel with hypofractionated, image guided, intensity modulated radiotherapy (HIGRT) in resectable and borderline resectable pancreatic cancer

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsResectable Pancreatic Cancers
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 17, 2014
Enrollment StartFeb 17, 2015
Primary CompletionNov 7, 2018
Study CompletionNov 14, 2022
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 11.5 years ago

Interventions

Gemcitabine/nab-Paclitaxeldrug

Prospective, single arm study ; eligible subjects will recieve 2 cycles of neoadjuvant Gemcitabine/nab-Paclitaxel. All chemotherapy administered to study subjects is standard of care. The chemotherapy combination, gemcitabine/nab-paclitaxel, is considered to be a standard-of-care, non-investigational chemotherapy combination; chemotherapy dosing and treatment schedule will be managed by the treating medical oncologist. Restaging will be completed post chemotherapy.

Radiation therapyradiation

5 fractions of hypofractionated IGRT or IMRT at 5Gy per fraction will be delivered before surgery. Restaging will be completed post radiation therapy.

Sugical resectionother

Surgical resection of the pancreas post radiation therapy

Adjuvant chemotheapydrug

Adjuvant chemotherapy may be given after surgery at the clinical discretion of the medical oncologist