Clinical trial · Interventional
Preoperative Chemoradiotherapy With Gemcitabine for Resectable Pancreatic Carcinoma
A Phase 2 Study of Preoperative Chemoradiotherapy With Gemcitabine for Resectable Pancreatic Carcinoma
NCT01333124CI-TRIAL-00044498terminatedPhase 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): Recruitment delay
Summary
Brief summary (as posted)
This phase II study is to evaluate the efficacy of preoperative chemoradiotherapy with gemcitabine (400mg/m2, weekly) for resectable pancreatic cancer.
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 |
|---|---|---|---|
| Resectable Pancreatic Carcinoma | Pancreatic Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chemoradiotherapy with Gemcitabine | Radiation | — | UNRESOLVED |
| Radiation: chemoradiotherapy with Gemcitabine | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiation: chemoradiotherapy with Gemcitabine
- description
- Radiation: chemoradiotherapy with Gemcitabine All patients will receive gemcitabine 400 mg/m2 as an intravenous 30-min infusion on day 1, 8, 15, 22, and 29 with radiotherapy.After 4-6 week from end date of chemoradiotherapy, patients undergo preoperative evaluation including CT, PET, CA19-9, CEA. If the patient is feasible for resection on this evaluation, the surgery is performed in 1 to 2 weeks. After surgery, patients will receive gemcitabine 1000 mg/m2 as an intravenous 30-min infusion on day 1, 8, and 15 for every 28 days. Subjects will be treated for at least 1 cycle and to a maximum of four cycles of adjuvant chemotherapy unless there is documented relapse, unacceptable adverse events or withdrawal of consent.
- interventionNames
- Radiation: chemoradiotherapy with Gemcitabine
- Radiation: Radiation: chemoradiotherapy with Gemcitabine
Primary outcomes (1)
- measure
- Complete resection rate
- timeFrame
- Within the first 30 days after surgery
- description
- To evaluate the impact of preoperative chemoradiotherapy with gemcitabine by analyzing complete resection rate (R0).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with resectable pancreatic adenocarcinoma * Age over 18 years old and younger than 70 year old * Performance status (ECOG scale): 0-1 * Adequate organ functions * Hb ≥9.0 g/dl * ANC ≥1,500/mm3 * PLT ≥100,000/mm3 * Liver function: Total Bilirubin ≤3.0 mg/dl AST/ALT/ALP ≤3× upper limit of normal * Creatinine ≤1.5 ULN * Patients should sign a written informed consent before study entry. Exclusion Criteria: * Tumor type other than adenocarcinoma * Unresectable for resection on preoperative evaluation * Other primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence) * Prior systemic therapy (for instance, cytotoxic chemotherapy or active/passive immunotherapy) * Prior radiotherapy * Major surgery within 4 weeks prior to study treatment * Serious illness or medical conditions, as follows; * congestive heart failure (NYHA class III or IV) * unstable angina or myocardial infarction within the past 6 months, * significant arrhythmias requiring medication and conduction abnormality such as over 2nd degree AV block * uncontrolled hypertension * hepatic cirrhosis( ≥ Child class B) * interstitial pneumonia, pulmonary adenomatosis * psychiatric disorder that may interfere with and/or protocol compliance * unstable diabetes mellitus * uncontrolled ascites or pleural effusion * active infection * Received any investigational drug or agent/procedure, i.e. participation in another trial within 4 weeks before beginning treatment with study drug * Pregnant or lactating woman * Women of child bearing potential not using a contraceptive method * Sexually active fertile men not using effective birth control during medication of study drug and up to 6 months after completion of study drug if their partners are women of child-bearing potential * Any patients judged by the investigator to be unfit to participate in the study
References
Publications (0)
Data not yet available
No reference posted for this study.