Clinical trial · Interventional
Chemotherapy and Radiation Following Pancreatic Surgery
A Phase II Trial Of Adjuvant Chemoradiation Following Pancreatic Resection For Adenocarcinomas Of The Pancreas Using 3-D Conformal Radiation With Cisplatin, 5FU, And Alpha-Interferon As Radiosensitizing Agents Followed By Gemcitabine
- 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)
To describe the overall survival and disease-free survival in pancreatic cancer patients treated with adjuvant chemoradiation with cisplatin, continuous infusion 5FU and interferon alpha followed by gemcitabine. To describe the toxicities associated with adjuvant chemoradiation with cisplatin. 5FU and interferon alfa followed by gemcitabine in patients with pancreatic cancers.
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 (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FU | Drug | Fluorouracil | ALIAS |
| Alpha-interferon | Drug | — | UNRESOLVED |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Pancreatic Surgery | Procedure | — | UNRESOLVED |
| Radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- Surgery (pancreaticoduodenectomy, either standard or pylorus-preserving, with either standard or extended lymph node dissection, with or without portal vein resection) should occur at 8 weeks (plus or minus 2, not to exceed 10) Radiation therapy will occur 8 weeks (plus or minus 2, not to exceed 10) postoperatively. Daily dose of 1.8 Gy five days per week. The first 45 Gy will be given to planning target volume 1. After 45 Gy, portals will be reduced to encompass planning target volume 2. The boost dose will be 5.4 Gy. Cisplatin IV 25 mg/m2 on days 1, 8, 15, 22, 29, and 36 during radiation. 5-FU CIVI at 175 mg/m2/d on days 1-38 without interruption during radiation. Alpha-interferon SQ 3,000,000 units on Mondays, Wednesdays, and Fridays during radiation therapy. Gemcitabine IV 1000 mg/m2 4 weeks after conclusion of radiation (on a 3 weeks on/1 week off schedule) on days 71, 78, 85, 99, 106, and 113.
- interventionNames
- Procedure: Pancreatic Surgery
- Radiation: Radiation therapy
- Drug: Cisplatin
- Drug: 5-FU
- Drug: Alpha-interferon
- Drug: Gemcitabine
Primary outcomes (1)
- measure
- To describe the overall survival and disease-free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
* Resected adenocarcinoma of the pancreas * ECOG performance status 0 or 1 * No prior chemotherapy or radiation therapy for cancer within the last five years. * Prior history of other malignancies allowable, if stable or requiring no active therapy. * Absolute neutrophil count \>/= 1,500/mm3, platelet count \>/= 100,000/mm3, and hemoglobin \>/= 9 g/dL. * Serum creatinine \</= 2 mg/dL. * Serum bilirubin \</= 3.0 mg/dL. * Serum transaminases ( SGOT and SGPT) \</= 5-fold the institutional upper limits. * No co-existing severe medical illnesses, such as unstable angina, uncontrolled diabetes mellitus, uncontrolled arrhythmia or uncontrolled infection. * Able to sign an informed consent.
References
Publications (1)
- DERIVEDLinehan DC, Tan MC, Strasberg SM, Drebin JA, Hawkins WG, Picus J, Myerson RJ, Malyapa RS, Hull M, Trinkaus K, Tan BR Jr. Adjuvant interferon-based chemoradiation followed by gemcitabine for resected pancreatic adenocarcinoma: a single-institution phase II study. Ann Surg. 2008 Aug;248(2):145-51. doi: 10.1097/SLA.0b013e318181e4e9. PMID 18650621