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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
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.
31 July 2019
Quick facts
| Lead sponsor | Medical University of Silesia |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 1 January 2017 |
| Primary completion | 31 July 2019 |
| Estimated completion | 31 July 2019 |
| Sites | 1 location across Poland |
Drugs / interventions tested
- Patients will receive initial chemotherapy, followed by evaluation of the response to the treatment, followed by SBRT, followed by chemotherapy.
Conditions studied
- Cancer of Pancreas — all drugs for Cancer of Pancreas →
- Unresectable Pancreatic Cancer — all drugs for Unresectable Pancreatic Cancer →
- Chemotherapy Effect — all drugs for Chemotherapy Effect →
- SBRT — all drugs for SBRT →
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):
-
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 -
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:
- PubMed search for NCT03891472
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other Medical University of Silesia trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03891472 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Medical University of Silesia
- Last refreshed: 13 November 2019
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.
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