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Clinical Phase II Clinical Study Evaluating the Toxicity and Efficacy of mFOLFIRINOX Associated With SBRT (Stereotactic Radiotherapy) in Patients With Unresectable Locally Advanced Pancreatic Cancer

NCT03891472 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-11-13

No results posted yet for this study

Summary

Primary goal:

Improvement of the therapeutic index by reducing the toxicity of treatment and increasing local control of the cancer process while evaluating the possibility of conversion to the surgical status.

Secondary targets:

* Survival rate (OS) assessment in patients treated with mFOLFIRINOX + SBRT
* Assessment of quality of life using questionnaires: EQ-5D, EORTC (QLQ-C30) and pancreatic cancer-specific QLQ PAS module 26
* Early toxicity \<3 months after completion of SBRT treatment.
* Percentage of local control (1-year)

Conditions

  • Cancer of Pancreas
  • Unresectable Pancreatic Cancer
  • Chemotherapy Effect
  • SBRT

Interventions

DRUG

Patients will receive initial chemotherapy, followed by evaluation of the response to the treatment, followed by SBRT, followed by chemotherapy.

mFOLFIRINOX \> SBRT \> mFOLFIRINOX \> Surgical Intervention

Sponsors & Collaborators

  • Medical University of Silesia

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2019-07-31
Completion
2019-07-31

Countries

  • Poland

Study Locations

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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 NCT03891472 on ClinicalTrials.gov