CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 35 enrolled
Drug / intervention
Gemcitabine +2 moredrug
Likely dose
Gemcitabine 1,000 mg/m2from 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/NCT01360593
NCT01360593Phase 2Completed
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Induction Gemcitabine/Capecitabine Followed by SBRT in Pancreatic Adenocarcinoma A Prospective Evaluation in Patients With Locally Advanced Pancreas Cancer

David A. Clump, MD, PhD·interventional·Posted May 25, 2011·Updated Mar 8, 2022

In Brief

A Phase 2 clinical trial evaluating Gemcitabine, Capecitabine, and 1 other intervention for Pancreatic Cancer. Completed, enrolled 35 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPancreatic Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 25, 2011
Enrollment StartJul 25, 2011
Primary CompletionMar 13, 2016
Study CompletionOct 1, 2018
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 15.1 years ago

Interventions

Gemcitabinedrug

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.

Capecitabinedrug

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.

Stereotactic Body Radiation Therapy (SBRT)radiation

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.