Clinical trial · Interventional
Proton Therapy for Unresectable Cancer (CA) of Pancreas
A Study Using Photon/Proton Beam Radiation Therapy and Chemotherapy for Unresectable Carcinoma of the Pancreas
NCT00685763CI-TRIAL-00029245PC01completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to find out what effects, good and/or bad, proton radiation and chemotherapy has on you and your 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 |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Proton radiation and chemotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Proton radiation and chemotherapy
- description
- Chemotherapy and Radiation Combination Proton radiation 59.4 cobalt gray equivalent(CGE) in 33 fx at 1.8 CGE per fx over 7 weeks. Capecitabine (Xeloda ®) 1,000 mg by mouth approximately every 12 hrs, 5 days/week starting the first day of radiation until the end of radiation, but on radiation days only. Consolidation Chemotherapy starting 4 weeks after the completion of radiation Gemcitabine (Gemzar ®) Suggested Regimen - 1,000mg/m2 by IV over 30 minutes once a week for 3 weeks (followed by a week of rest) for 12 total doses.
- interventionNames
- Radiation: Proton radiation and chemotherapy
Primary outcomes (1)
- measure
- Cumulative Incidence of grade3+ Bowel Perforation, Grade 3+ Bleeding (Ocurring Withing 1 Years) and grade4+ Nonhematologic Acute Adverse Events (Limited to Within 90 Days of Treatment Start)
- timeFrame
- 1 year following the completion of radiation therapy
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: Pathologically confirmed adenocarcinoma of the pancreas. Patients must be medically inoperable or have unresectable disease Exclusion Criteria: * Evidence of distant metastasis; evidence of metastatic disease in the major viscera (organs), peritoneal seeding and/or ascites. * Previous irradiation to the abdomen that would compromise the ability to deliver the prescribed treatment. * Prior surgical resection.
References
Publications (21)
- BACKGROUNDSaif MW. Pancreatic cancer: highlights from the 42nd annual meeting of the American Society of Clinical Oncology, 2006. JOP. 2006 Jul 10;7(4):337-48. PMID 16832131
- BACKGROUNDSeydel HG, Stablein DM, Leichman LP, Kinzie JJ, Thomas PR. Hyperfractionated radiation and chemotherapy for unresectable localized adenocarcinoma of the pancreas. The Gastrointestinal Tumor Study Group experience. Cancer. 1990 Apr 1;65(7):1478-82. doi: 10.1002/1097-0142(19900401)65:73.0.co;2-3. PMID 2138054
- BACKGROUNDSchuster-Uitterhoeve AL, Gonzalez Gonzalez D, Blank LE. Radiotherapy with multiple fractions per day in pancreatic and bile duct cancer. Radiother Oncol. 1986 Nov;7(3):205-13. doi: 10.1016/s0167-8140(86)80031-7. PMID 3809584
- BACKGROUNDUeno H, Okusaka T, Ikeda M, Tokuuye K. Phase I study of hyperfractionated radiation therapy with protracted 5-fluorouracil infusion in patients with locally advanced pancreatic cancer. Oncology. 2004;67(3-4):215-21. doi: 10.1159/000081320. PMID 15557781
- BACKGROUNDBen-Josef E, Shields AF, Vaishampayan U, Vaitkevicius V, El-Rayes BF, McDermott P, Burmeister J, Bossenberger T, Philip PA. Intensity-modulated radiotherapy (IMRT) and concurrent capecitabine for pancreatic cancer. Int J Radiat Oncol Biol Phys. 2004 Jun 1;59(2):454-9. doi: 10.1016/j.ijrobp.2003.11.019. PMID 15145162
- BACKGROUNDHsiung-Stripp DC, McDonough J, Masters HM, Levin WP, Hahn SM, Jones HA, Metz JM. Comparative treatment planning between proton and X-ray therapy in pancreatic cancer. Med Dosim. 2001 Fall;26(3):255-9. doi: 10.1016/s0958-3947(01)00072-3. PMID 11704461
- BACKGROUNDMackean M, Planting A, Twelves C, Schellens J, Allman D, Osterwalder B, Reigner B, Griffin T, Kaye S, Verweij J. Phase I and pharmacologic study of intermittent twice-daily oral therapy with capecitabine in patients with advanced and/or metastatic cancer. J Clin Oncol. 1998 Sep;16(9):2977-85. doi: 10.1200/JCO.1998.16.9.2977.