Clinical trial · Observational
A Phase III Study of Pancreatic Cancer
A Randomized Phase III Study of Adjuvant Gemcitabine Versus Gemcitabine Plus Concurrent Chemoradiation in Pancreatic Cancer Underwent Curative Intent (R0 / R1) Resection
- 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)
Study Design： Adjuvant gemcitabine therapy has been shown to improve recurrence-free survival in pancreatic cancer underwent curative intent resection. This study is to evaluate whether combining concurrent chemo-radiotherapy can further improve the recurrence-free survival benefit of adjuvant gemcitabine chemotherapy in pancreatic cancer underwent curative resection. Research Objective and Study End Points 1. Primary endpoint： The primary end point is disease free survival. 2. Secondary endpoints： The secondary end points are to evaluate the overall survival, local and distant recurrence rate, and impact on quality of life after adjuvant gemcitabine with or without CCRT in curatively resected pancreatic cancer. Furthermore, the clinical, pathological and molecular prognostic factors in curatively resected pancreatic cancers will be evaluated.
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 (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- pancreatic cancer
- description
- resected pancreatic cancer
Primary outcomes (1)
- measure
- The primary end-point is recurrence-free survival.
- timeFrame
- Pancreatic Cancer Disease Committee
Secondary outcomes (1)
- measure
- The secondary end-points are overall survival; local and distant control rate, and the quality of life.
- timeFrame
- Pancreatic Cancer Disease Committee
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
A.Eligibility Criteria 1. Patients with pancreatic cancer after curative intent resection. 2. The histology of resected tumor has to be adenocarcinoma. 3. Age 20-75 years. 4. ECOG performance scale 0-1. 5. Patients must have normal organ and marrow function as defined below. 6. The effects of study agents on the developing human fetus at the recommended therapeutic dose are unknown. 7. to sign a written informed consent. 8. Registered within 6 weeks after surgery. 9. Preoperative abdominal CT or MRI with contrast enhancement. B.Exclusion Criteria 1. Patients with gross residual, macroscopic positive resection margin or distant metastases. 2. Patients may not be receiving any other investigational agents. 3. Patients who have had prior chemotherapy or radiotherapy are not eligible. 4. History of allergic reactions. 5. Patients who had non-curable second primary malignancy. 6. Uncontrolled intercurrent illness including. 7. Pregnant women. 8. receiving immuno-suppressive therapy、anti-coagulants.
References
Publications (1)
- DERIVEDChiu YF, Liu TW, Shan YS, Chen JS, Li CP, Ho CL, Hsieh RK, Hwang TL, Chen LT, Ch'ang HJ; Taiwan Cooperative Oncology Group pancreatic cancer study group. Carbohydrate Antigen 19-9 Response to Initial Adjuvant Chemotherapy Predicts Survival and Failure Pattern of Resected Pancreatic Adenocarcinoma but Not Which Patients Are Suited for Additional Adjuvant Chemoradiation Therapy: From a Prospective Randomized Study. Int J Radiat Oncol Biol Phys. 2023 Sep 1;117(1):74-86. doi: 10.1016/j.ijrobp.2023.02.061. Epub 2023 Apr 11. PMID 37055279