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Gemcitabine/Nab-Paclitaxel With HIGRT in Resectable Pancreatic Cancer

NCT02318095 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-10-26

Study results available
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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

Conditions

  • Resectable Pancreatic Cancers

Interventions

DRUG

Gemcitabine/nab-Paclitaxel

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

Radiation therapy

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

OTHER

Sugical resection

Surgical resection of the pancreas post radiation therapy

DRUG

Adjuvant chemotheapy

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

Sponsors & Collaborators

Principal Investigators

  • Manisha Palta, MD · Duke Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-17
Primary Completion
2018-11-07
Completion
2022-11-14

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02318095 on ClinicalTrials.gov