CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 14 enrolled
Drug / intervention
FOLFIRINOX or gemcitabine/abraxane +1 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/NCT02873598
NCT02873598Phase 1Completed
CompareCT.gov

A Dose Escalation Trial of Stereotactic Body Radiotherapy (SBRT) After Induction Chemotherapy for Locally Advanced Pancreatic Cancer

University of Colorado, Denver·interventional·Posted Aug 19, 2016·Updated Dec 19, 2022

In Brief

A Phase 1 clinical trial evaluating FOLFIRINOX or gemcitabine/abraxane and SBRT for Pancreatic Cancer. Completed, enrolled 14 participants across 1 site.

Detailed Summary

This is a dose escalation trial to evaluate the safety of stereotactic body radiotherapy (SBRT) delivered in 3 fractions for patients with locally advanced pancreatic cancer (LAPC) who have received induction chemotherapy (FOLFIRINOX or gemcitabine and nab-paclitaxel).

Study Details

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

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 19, 2016
Enrollment StartNov 17, 2016
Primary CompletionJun 7, 2019
Study CompletionNov 28, 2022
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 9.9 years ago

Interventions

FOLFIRINOX or gemcitabine/abraxanedrug

Patients will have received induction chemotherapy for 3+ months with either FOLFIRINOX or gemcitabine/abraxane with at least stable disease.

SBRTradiation

After completion of induction chemotherapy, stereotactic body radiation therapy (SBRT) will be administered in 3 fractions, every other day, on an outpatient basis. Dose escalation will start with dose level 1 (9 Gy x 3 fractions) and increase by 1 Gy per fraction at each dose level, dose level 2 will be 10 Gy x 3 fractions and dose level 3 will be 11 Gy x 3 fractions.