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NCT03891472

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

Completed Phase 2 Last updated 13 November 2019
What this trial tests

Phase 2 trial testing Patients will receive initial chemotherapy, followed by evaluation of the response to the treatment, followed by SBRT, followed by chemotherapy. in Cancer of Pancreas in 40 participants. Completed in 31 July 2019.

Timeline
1 January 2017
Primary endpoint
31 July 2019
31 July 2019

Quick facts

Lead sponsorMedical University of Silesia
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment40
Start date1 January 2017
Primary completion31 July 2019
Estimated completion31 July 2019
Sites1 location across Poland

Drugs / interventions tested

Conditions studied

Sponsor

Medical University of Silesia

Who can join

18 and older, any sex, with Cancer of Pancreas or Unresectable Pancreatic Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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)

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Photodynamic Therapy and Hyperthermia in Combination Treatment-Neglected Forces in the Fight against Cancer.
    Bienia A, Wiecheć-Cudak O, Murzyn AA, Krzykawska-Serda M. · · 2021 · cited 36× · PMID 34452108 · DOI 10.3390/pharmaceutics13081147
  2. Combination of modified FOLFIRINOX with stereotactic body radiotherapy as an induction therapy for locally advanced pancreatic adenocarcinoma - a prospective single-arm study.
    Piątek M, Bieńkowski M, Kuśnierz K, Pilch-Kowalczyk J, et al · · 2024 · cited 2× · PMID 38800534 · DOI 10.5114/wo.2024.137760

Verify or expand the search:

Other recruiting trials for Cancer of Pancreas

Currently open trials in the same condition.

Other Medical University of Silesia trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03891472.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing