CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 35 enrolled
Drug / intervention
gemcitabine hydrochloride +7 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/NCT00609336
NCT00609336Phase 2Completed

A Phase II Study Induction Chemotherapy, Neoadjuvant Chemoradiotherapy, Surgical Resection and Adjuvant Chemotherapy for Patients With Locally Advanced, Resectable Pancreatic Adenocarcinoma

University of Washington·interventional·Posted Feb 7, 2008·Updated Jul 13, 2017

In Brief

A Phase 2 clinical trial evaluating gemcitabine hydrochloride, docetaxel, and 6 other interventions for Adenocarcinoma of the Pancreas and 4 related conditions. Completed, enrolled 35 participants across 1 site.

Detailed Summary

This phase II trial studies how well giving combination chemotherapy together with intensity-modulated radiation therapy (IMRT) and surgery works in treating patients with localized pancreatic cancer that can be removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride, docetaxel, capecitabine, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy, such as IMRT, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving more than one drug (combination chemotherapy) together with intensity-modulated radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 7, 2008
Enrollment StartJan 1, 2008
Primary CompletionNov 1, 2014
Study CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 18.4 years ago

Interventions

gemcitabine hydrochloridedrug

Given IV

docetaxeldrug

Given IV

capecitabinedrug

Given PO

intensity-modulated radiation therapyradiation

Undergo IMRT

oxaliplatindrug

Given IV

pancreatic surgical procedureprocedure

Undergo pancreaticoduodenectomy

therapeutic conventional surgeryprocedure

Undergo therapeutic conventional surgery

laboratory biomarker analysisother

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