Postoperative Proton Radiotherapy With Chemo for Pancreatic Cancer
NCT ID: NCT01553019
Last Updated: 2017-09-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
2 participants
INTERVENTIONAL
2011-10-31
2017-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1- R(0) negative
50.40 cobalt gray equivalent (CGE) Proton Radiation and concomitant chemotherapy with weekly gemcitabine
Proton radiation
Proton Radiation Therapy: R(0) negative ... 50.40 cobalt gray equivalent (CGE) at 1.8 CGE per fraction ; R(1) micro-positive ...54.00 CGE at 1.8 CGE per fraction; R(2) gross positive...59.40 CGE at 1.8 CGE per fraction
Gemcitabine
Gemcitabine 300 mg/m2 infused over 30 minutes, weekly during proton therapy.
2- R(1) micro-positive
54.00 cobalt gray equivalent(CGE) Proton Radiation and concomitant chemotherapy with weekly gemcitabine
Proton radiation
Proton Radiation Therapy: R(0) negative ... 50.40 cobalt gray equivalent (CGE) at 1.8 CGE per fraction ; R(1) micro-positive ...54.00 CGE at 1.8 CGE per fraction; R(2) gross positive...59.40 CGE at 1.8 CGE per fraction
Gemcitabine
Gemcitabine 300 mg/m2 infused over 30 minutes, weekly during proton therapy.
3- R(2) gross positive
59.40 cobalt gray equivalent (CGE) Proton Radiation and concomitant chemotherapy with weekly gemcitabine
Proton radiation
Proton Radiation Therapy: R(0) negative ... 50.40 cobalt gray equivalent (CGE) at 1.8 CGE per fraction ; R(1) micro-positive ...54.00 CGE at 1.8 CGE per fraction; R(2) gross positive...59.40 CGE at 1.8 CGE per fraction
Gemcitabine
Gemcitabine 300 mg/m2 infused over 30 minutes, weekly during proton therapy.
Interventions
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Proton radiation
Proton Radiation Therapy: R(0) negative ... 50.40 cobalt gray equivalent (CGE) at 1.8 CGE per fraction ; R(1) micro-positive ...54.00 CGE at 1.8 CGE per fraction; R(2) gross positive...59.40 CGE at 1.8 CGE per fraction
Gemcitabine
Gemcitabine 300 mg/m2 infused over 30 minutes, weekly during proton therapy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Post resection CA19-9 tumor marker baseline
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University of Florida
OTHER
Responsible Party
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Principal Investigators
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Romaine C Nichols, MD
Role: PRINCIPAL_INVESTIGATOR
University of Florida Proton Therapy Institute
Locations
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University of Florida Proton Therapy Institute
Jacksonville, Florida, United States
Provision Proton Therapy Center
Knoxville, Tennessee, United States
Countries
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References
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Tepper 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.
Gudjonsson 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.
Regine 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.
Hattangadi et al Cancer 8/15/2009 p 3640-3650
Nichols 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.
Kalser 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.
Klinkenbijl 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.
Van Laethem JL, Van Cutsem E, Hammel P, Mornex F, Azria D, Van Tienhoven G, Peeters M, Praet M, Budach V, Haustermans K et al. Adjuvant chemotherapy alone vs. chemoradiation after curative resection for pancreatic cancer: phase II/III trial of the EORTC/FFCD/GERCOR groups.
Other Identifiers
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UFPTI 1013-PC03
Identifier Type: -
Identifier Source: org_study_id
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