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Gemcitabine/Capecitabine Followed by SBRT in Pancreatic Adenocarcinoma

NCT01360593 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2022-03-08

Study results available
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Summary

The current study seeks to further investigate the impact of up-front systemic therapy in combination with fractionated SBRT for potentially resectable, locally-advanced pancreatic adenocarcinoma.

Conditions

Interventions

DRUG

Gemcitabine

Gemcitabine will be administered for 2 weekly doses every 3 weeks commencing 12 weeks prior to stereotactic radiosurgery as follows: Gemcitabine 1,000 mg/m2 IV over 30 minutes on Day 1, and 8 of 21- day cycle. This will be done for up to 4 cycles.

DRUG

Capecitabine

Capecitabine will be taken orally twice daily on days 1-14 every 3 weeks for 4 cycles (12 weeks) prior to stereotactic radiosurgery as follows: Capecitabine 650 mg/m2 twice daily for days 1-14 every 3 weeks for up to 4 cycles.

RADIATION

Stereotactic Body Radiation Therapy (SBRT)

Fractionated SBRT will be delivered to patients that have stable disease, partial response, or complete response after chemo in the following manner: 12 Gy x 3 fractions (36 Gy total) This will be given every other day.

Sponsors & Collaborators

  • David A. Clump, MD, PhD

    lead OTHER

Principal Investigators

  • David A Clump, MD · UPMC Hillman Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-25
Primary Completion
2016-03-13
Completion
2018-10-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT01360593 on ClinicalTrials.gov