Clinical trial · Interventional
Efficacy and Feasibility of Combining FOLFIRINOX and Stereotactic Radiotherapy for Patients With Irresectable Locally Advanced Pancreatic Cancer.
NCT02292745CI-TRIAL-00046250LAPC-1completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to investigate whether combining FOLFIRINOX chemotherapy and stereotactic radiotherapy in patients with locally advanced pancreatic cancer leads to an increase in survival.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| stereotactic radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Stereotactic radiotherapy
- description
- Standard of care FOLFIRINOX treatment followed by stereotactic radiotherapy
- interventionNames
- Radiation: stereotactic radiotherapy
Primary outcomes (1)
- measure
- overall survival
- timeFrame
- up to 3.5 years after start of therapy
Secondary outcomes (6)
- measure
- number of toxicity events related to chemotherapy
- timeFrame
- up to 3.5 years after start of therapy
- measure
- radiological response rates after chemotherapy and radiotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Cytological or histologically confirmation of pancreatic cancer. * WHO performance status of 0 or 1 * ASA classification I or II * Tumor considered locally advanced after diagnostic work-up including CT-imaging and diagnostic laparoscopy. * No evidence of metastatic disease * Largest tumor diameter \< 7 cm x 7 cm x 7 cm * Normal renal function (Creatinine ≥ 30 ml/min). * Normal liver tests (bilirubin \< 1.5 times normal; ALAT/ASAT \< 5 times normal) * Normal bone marrow function (WBC \> 3.0 x 10e9/L, platelets \> 100 x 10e9/L and hemoglobin \> 5.6 mmol/l) * Age \> 18 years and \< 75 years * Written informed consent Exclusion Criteria: * Prior radiotherapy, chemotherapy or resection (bypass surgery allowed). * Lymph node metastases from primary tumor outside the field of radiation. * Second primary malignancy except in situ carcinoma of the cervix, adequately treated non-melanoma skin cancer, or other malignancy treated at least 3 years previously without evidence of recurrence. * Pregnancy, breast feeding. * Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator.
References
Publications (1)
- DERIVEDSuker M, Nuyttens JJ, Eskens FALM, Haberkorn BCM, Coene PLO, van der Harst E, Bonsing BA, Vahrmeijer AL, Mieog JSD, Jan Swijnenburg R, Roos D, Koerkamp BG, van Eijck CHJ. Efficacy and feasibility of stereotactic radiotherapy after folfirinox in patients with locally advanced pancreatic cancer (LAPC-1 trial). EClinicalMedicine. 2019 Nov 19;17:100200. doi: 10.1016/j.eclinm.2019.10.013. eCollection 2019 Dec. PMID 31891135