Clinical trial · Interventional
A Clinical Study of UFT/Leucovorin, Radiotherapy With or Without Cetuximab Following Induction Gemcitabine Plus Capecitabine in Patients With Locally Advanced Pancreatic Cancer (PERU)
A Multicentre Randomised Phase II Clinical Study of UFT/Leucovorin, Radiotherapy With or Without Cetuximab Following Induction Gemcitabine Plus Capecitabine in Patients With Locally Advanced Pancreatic Cancer (PERU)
NCT01050426CI-TRIAL-00024270PERUterminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Data from other trials failed to demonstrate meaningful survival advantage
Summary
Brief summary (as posted)
The purpose is to assess the overall survival of patients receiving either UFT/LV + radiotherapy (RT) or UFT/LV + Cetuximab + RT after neo-adjuvant chemotherapy.
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 Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| UFT, Leucovorin | Other | — | UNRESOLVED |
| UFT/ Leucovorin + Cetuximab + Radiotherapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group 1
- description
- UFT/LV + RT
- interventionNames
- Other: UFT, Leucovorin
- type
- ACTIVE_COMPARATOR
- label
- Group 2
- description
- UFT/LV + RT + Cetuximab
- interventionNames
- Other: UFT/ Leucovorin + Cetuximab + Radiotherapy
Primary outcomes (1)
- measure
- One year overall survival, measured from the date of registration.
- timeFrame
- one year
Secondary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>18 * Histological or cytological diagnosis of adeno- or undifferentiated non-small cell carcinoma of pancreas. * Considered to be unresectable based on following: extensive peri-pancreatic lymph node involvement, encasement or occlusion of the SMV or SMV/portal vein confluence, direct involvement of SMA, coeliac axis, inferior vena cava or aorta. * Performance status 0-2 * No evidence of metastatic disease as determined by CT scan/ other investigations * Adequate bone marrow function with platelets\>100\^9/l; WBC\>3x10\^9/l;neutrophils\> 1.5x10\^9/l * Serum bilirubin ,1.5 x ULN and transaminases \< 2.5 x ULN * Calculated/measured GFR \>50ml/min * No concurrent uncontrolled medical condition * No active malignant disease other than non-melanotic skin cancer or carcinoma in situ of the uterine cervix over the last 10 years * Life expectancy \> 3months * Adequate contraceptive precautions * Informed written consent Exclusion Criteria: * medical or psychiatric conditions that compromise the patient's ability to give informed consent * Presence of met. disease * Concurrent uncontrolled medical conditions * Any previous chemo/RT or any investigational treatment for advanced pancreatic cancer. * Adjuvant chemo + fluoropyrimidine or gemcitabine within 12months of trial entry * Adjuvant RT with/without chemo for pancreatic cancer. * Pregnancy/breast feeding * Patients with known malabsorption syndromes ro a lack of physical treatment of the upper GI tract. * Patients with a known hypersensitivity to 5-FU or with a DPD deficiency. * Clinically significant CVD
References
Publications (0)
Data not yet available
No reference posted for this study.