Clinical trial · Interventional
Postoperative Proton Radiotherapy With Chemo for Pancreatic Cancer
A Phase II Trial of Postoperative Proton Radiotherapy With Concomitant Chemotherapy for Patients With Resected Pancreatic Adenocarcinoma
NCT01553019CI-TRIAL-00029429PC03completedPhase 2ClinicalTrials.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 combined with chemotherapy has on resected 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Proton radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- 1- R(0) negative
- description
- 50.40 cobalt gray equivalent (CGE) Proton Radiation and concomitant chemotherapy with weekly gemcitabine
- interventionNames
- Radiation: Proton radiation
- Drug: Gemcitabine
- type
- EXPERIMENTAL
- label
- 2- R(1) micro-positive
- description
- 54.00 cobalt gray equivalent(CGE) Proton Radiation and concomitant chemotherapy with weekly gemcitabine
- interventionNames
- Radiation: Proton radiation
- Drug: Gemcitabine
- type
- EXPERIMENTAL
- label
- 3- R(2) gross positive
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic proof of primary head of pancreas invasive adenocarcinoma managed with a potentially curative resection * Post resection CA19-9 tumor marker baseline Exclusion Criteria: \- Previous history of invasive malignancy (except non-melanoma skin cancer and low to intermediate risk prostate cancer) unless the patient has been disease free for at least 5 years prior to study consent
References
Publications (8)
- BACKGROUNDTepper J, Nardi G, Sutt H. Carcinoma of the pancreas: review of MGH experience from 1963 to 1973. Analysis of surgical failure and implications for radiation therapy. Cancer. 1976 Mar;37(3):1519-24. doi: 10.1002/1097-0142(197603)37:33.0.co;2-o. PMID 1260670
- BACKGROUNDGudjonsson B. Cancer of the pancreas. 50 years of surgery. Cancer. 1987 Nov 1;60(9):2284-303. doi: 10.1002/1097-0142(19871101)60:93.0.co;2-v. PMID 3326653
- BACKGROUNDRegine WF, Winter KA, Abrams RA, Safran H, Hoffman JP, Konski A, Benson AB, Macdonald JS, Kudrimoti MR, Fromm ML, Haddock MG, Schaefer P, Willett CG, Rich TA. Fluorouracil vs gemcitabine chemotherapy before and after fluorouracil-based chemoradiation following resection of pancreatic adenocarcinoma: a randomized controlled trial. JAMA. 2008 Mar 5;299(9):1019-26. doi: 10.1001/jama.299.9.1019. PMID 18319412
- BACKGROUNDHattangadi et al Cancer 8/15/2009 p 3640-3650
- BACKGROUNDNichols RC Jr, Huh SN, Prado KL, Yi BY, Sharma NK, Ho MW, Hoppe BS, Mendenhall NP, Li Z, Regine WF. Protons offer reduced normal-tissue exposure for patients receiving postoperative radiotherapy for resected pancreatic head cancer. Int J Radiat Oncol Biol Phys. 2012 May 1;83(1):158-63. doi: 10.1016/j.ijrobp.2011.05.045. Epub 2012 Jan 13. PMID 22245197
- BACKGROUNDKalser MH, Ellenberg SS. Pancreatic cancer. Adjuvant combined radiation and chemotherapy following curative resection. Arch Surg. 1985 Aug;120(8):899-903. doi: 10.1001/archsurg.1985.01390320023003. PMID 4015380
- BACKGROUNDKlinkenbijl JH, Jeekel J, Sahmoud T, van Pel R, Couvreur ML, Veenhof CH, Arnaud JP, Gonzalez DG, de Wit LT, Hennipman A, Wils J. Adjuvant radiotherapy and 5-fluorouracil after curative resection of cancer of the pancreas and periampullary region: phase III trial of the EORTC gastrointestinal tract cancer cooperative group. Ann Surg. 1999 Dec;230(6):776-82; discussion 782-4. doi: 10.1097/00000658-199912000-00006.