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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.
Proton radiation with concomitant chemotherapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1- R(0) negative | Experimental | 50.40 cobalt gray equivalent (CGE) Proton Radiation and concomitant chemotherapy with weekly gemcitabine |
|
| 2- R(1) micro-positive | Experimental | 54.00 cobalt gray equivalent(CGE) Proton Radiation and concomitant chemotherapy with weekly gemcitabine |
|
| 3- R(2) gross positive | Experimental | 59.40 cobalt gray equivalent (CGE) Proton Radiation and concomitant chemotherapy with weekly gemcitabine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proton radiation | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Radiation Toxicity | Assessment of acute/late severe (defined as grade 3-5) radiation toxicity at the completion of therapy. Acute toxicity will be defined to be toxicity occurring within 90 days from the start of radiation treatment, and late toxicity will be defined as toxicity occurring more than 90 days from the start of radiation treatment. | 90 days after completion of RT |
| Measure | Description | Time Frame |
|---|---|---|
| Survival Rate | One year overall survival rate | 1 year after completion of RT |
| Response rate via CA 19-9 | Every 3 months for 2 years, then every 6 months for 3-5 years then annually thereafter |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Romaine C Nichols, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida Proton Therapy Institute | Jacksonville | Florida | 32206 | United States | ||
| Provision Proton Therapy Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1260670 | Background | 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. | |
| 3326653 | Background | 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. |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D061766 | Proton Therapy |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D063193 | Heavy Ion Radiotherapy |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D006571 | Heterocyclic Compounds |
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| Gemcitabine | Drug | Gemcitabine 300 mg/m2 infused over 30 minutes, weekly during proton therapy. |
|
|
| Knoxville |
| Tennessee |
| 37909 |
| United States |
| 18319412 | Background | 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. |
| Background | Hattangadi et al Cancer 8/15/2009 p 3640-3650 |
| 22245197 | Background | 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. |
| 4015380 | Background | 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. |
| 10615932 | Background | 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. |
| Background | 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. |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D003841 |
| Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |