Clinical trial · Interventional
Neoadjuvant Chemoradiation in Patients With Borderline Resectable Pancreatic Cancer
Multicenter Prospective Randomized Phase II/III Study of Neoadjuvant Chemoradiation With Gemcitabine in Patients With Borderline Resectable Pancreatic Cancer
- 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)
Previous reports suggest benefit of neoadjuvant chemoradiation treatment for borderline resectable pancreas cancer. This study is a multicenter prospective randomized phase II/III study of neoadjuvant chemoradiation with gemcitabine in patients with borderline resectable pancreas cancer. The study is designed in 2 arms, one with upfront surgery and the other with neoadjuvant chemoradiation therapy.
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 |
|---|---|---|---|
| Neoadjuvant chemoradiation | Drug | — | UNRESOLVED |
| Upfront surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Neoadjuvant
- description
- Neoadjuvant - operation - maintenance chemotherapy
- interventionNames
- Drug: Neoadjuvant chemoradiation
- type
- ACTIVE_COMPARATOR
- label
- Upfront surgery
- description
- Operation - adjuvant chemoradiation - maintenance chemotherapy
- interventionNames
- Procedure: Upfront surgery
Primary outcomes (1)
- measure
- 2-year survival rate
- timeFrame
- 2-year actual survival outcome
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * \>18 years old or \<75 years old * ECOG 0-2 * biopsy proven adenocarcinoma of the pancreas * no history of previous chemotherapy * borderline resectable pancreas cancer * no distant metastasis * WBC at least 3,000/mm3 or absolute neutrophil count at least 1,500/mm3, Platelet count at least 125,000/mm3 * Bilirubin less than 2.5 mg/dL AST less than 5 times upper limit of normal * Creatinine no greater than 1.5 times upper limit of normal * informed consent Exclusion Criteria: * history of previous chemotherapy * history of radiation at \>25% area of bone marrow * stage unspecified, with distant metastasis, recurrent pancreas cancer * history of malignant neoplasm (except stage 0 cancer, skin in situ cancer except malignant melanoma). Patients who are NED after 5 years after treatment of malignant neoplasm can be candidate of this study * pregnant, breast-feeding patient * uncontrolled or active infection * uncontrolled cardiopulmonary disease
References
Publications (0)
Data not yet available