Proton Radiation for Unresectable, Borderline Resectable, or Medically Inoperable Carcinoma of the Pancreas
NCT ID: NCT02598349
Last Updated: 2025-09-09
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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RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2016-04-30
2040-10-31
Brief Summary
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Detailed Description
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In addition, If surgery is an option, then surgical resection will be performed at least 8 weeks after treatment with radiation and chemotherapy.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Proton Radiation with capecitabine
The following will be performed in this group: Proton Radiation Therapy with concomitant oral chemotherapy, capecitabine taken on radiation treatment days for 6 weeks. A surgical resection will be performed between 8 and 16 weeks if radiographic studies suggest operability.
Proton Radiation
Proton Radiation 40.50 Gy relative biological effectiveness (RBE) in 18 fractions to gross disease and elective nodal volume followed by a 22.50 Gy (RBE) in 10 fraction boost to gross disease. Total dose 63 Gy (RBE) in 28 fractions over 6 weeks.
Capecitabine
Concomitant oral chemotherapy, capecitabine 1000mg by mouth twice daily, 5 days a week (M-F) on radiation days only.
Surgical resection
Surgery between 8 and 16 weeks of radiotherapy completion if radiographic studies suggest operability.
Interventions
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Proton Radiation
Proton Radiation 40.50 Gy relative biological effectiveness (RBE) in 18 fractions to gross disease and elective nodal volume followed by a 22.50 Gy (RBE) in 10 fraction boost to gross disease. Total dose 63 Gy (RBE) in 28 fractions over 6 weeks.
Capecitabine
Concomitant oral chemotherapy, capecitabine 1000mg by mouth twice daily, 5 days a week (M-F) on radiation days only.
Surgical resection
Surgery between 8 and 16 weeks of radiotherapy completion if radiographic studies suggest operability.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have either unresectable, borderline resectable or medically inoperable carcinoma of the pancreas, or refusing surgery.
* A biliary obstruction is able to participate as long as a drainage tube is in place prior to starting treatment with Proton radiation,
* Participants of child-producing potential must be willing to use contraception while on treatment and for at least 12 months thereafter.
* Required pretreatment laboratory parameters:
* Absolute granulocyte count (AGC/ANC) ≥ 1.8 thou/mm3
* Platelet count ≥ 100,000/mm3
* Bilirubin \< 2 mg/dl
* ALT/SGPT \< 3x upper limit of normal
* Creatinine \< 3 mg/dl
Exclusion Criteria
* Prior surgical resection.
* Previous history of invasive malignancy (except non-melanoma skin cancer and low to intermediate risk prostate cancer) unless the participant has been disease free for 5 years prior to registration.
* Active or untreated infection,
* Pregnant or breastfeeding women or subjects of child producing potential not willing to use medically acceptable contraception while on treatment and for at least 12 months thereafter.
* Previous Radiation to the abdomen.
18 Years
ALL
No
Sponsors
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University of Florida Health
OTHER
Proton Collaborative Group
NETWORK
Responsible Party
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Principal Investigators
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Romaine C. Nichols, MD
Role: PRINCIPAL_INVESTIGATOR
UF Health Proton Therapy Institute
Locations
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University of Florida Proton Therapy Institute
Jacksonville, Florida, United States
Northwestern Medicine Chicago Proton Center
Warrenville, Illinois, United States
McLaren Proton Therapy Center
Flint, Michigan, United States
Inova Schar Cancer Institute
Fairfax, Virginia, United States
Countries
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Facility Contacts
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References
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Katz MH, Pisters PW, Evans DB, Sun CC, Lee JE, Fleming JB, Vauthey JN, Abdalla EK, Crane CH, Wolff RA, Varadhachary GR, Hwang RF. Borderline resectable pancreatic cancer: the importance of this emerging stage of disease. J Am Coll Surg. 2008 May;206(5):833-46; discussion 846-8. doi: 10.1016/j.jamcollsurg.2007.12.020. Epub 2008 Mar 17.
Ashman JB, Moss AA, Rule WG, Callister MG, Reddy KS, Mulligan DC, Collins JM, De Petris G, Gunderson LL, Borad M. Preoperative chemoradiation and IOERT for unresectable or borderline resectable pancreas cancer. J Gastrointest Oncol. 2013 Dec;4(4):352-60. doi: 10.3978/j.issn.2078-6891.2013.006.
R. C. Nichols, C. G. Morris, D. Bose, S. J. Hughes, J. A. Stauffer, S. A. Celinski, R. C. Martin II, E. A. Johnson, R. A. Zaiden, M. S. Rutenberg ;O51: Feasibility of pancreatectomy after high dose proton therapy for unresectable pancreatic cancer. (2014) Proceedings to the 1 Annual Meeting for the Particle Therapy Cooperative Group - North America (PTCOG-NA), 27-29 October 2014. International Journal of Particle Therapy: Winter 2014, Vol. 1, No. 3, pp. 759-824.
Pawlik TM, Gleisner AL, Cameron JL, Winter JM, Assumpcao L, Lillemoe KD, Wolfgang C, Hruban RH, Schulick RD, Yeo CJ, Choti MA. Prognostic relevance of lymph node ratio following pancreaticoduodenectomy for pancreatic cancer. Surgery. 2007 May;141(5):610-8. doi: 10.1016/j.surg.2006.12.013. Epub 2007 Mar 23.
Winter JM, Brennan MF, Tang LH, D'Angelica MI, Dematteo RP, Fong Y, Klimstra DS, Jarnagin WR, Allen PJ. Survival after resection of pancreatic adenocarcinoma: results from a single institution over three decades. Ann Surg Oncol. 2012 Jan;19(1):169-75. doi: 10.1245/s10434-011-1900-3. Epub 2011 Jul 15.
Lee RY, Nichols RC Jr, Huh SN, Ho MW, Li Z, Zaiden R, Awad ZT, Ahmed B, Hoppe BS. Proton therapy may allow for comprehensive elective nodal coverage for patients receiving neoadjuvant radiotherapy for localized pancreatic head cancers. J Gastrointest Oncol. 2013 Dec;4(4):374-9. doi: 10.3978/j.issn.2078-6891.2013.043.
Dholakia AS, Kumar R, Raman SP, Moore JA, Ellsworth S, McNutt T, Laheru DA, Jaffee E, Cameron JL, Tran PT, Hobbs RF, Wolfgang CL, Herman JM. Mapping patterns of local recurrence after pancreaticoduodenectomy for pancreatic adenocarcinoma: a new approach to adjuvant radiation field design. Int J Radiat Oncol Biol Phys. 2013 Dec 1;87(5):1007-15. doi: 10.1016/j.ijrobp.2013.09.005.
Rapp CT, Rutenberg MS, Morris CG, Nichols RC. Dose-escalated proton therapy with elective nodal irradiation and concomitant chemotherapy for unresectable, borderline resectable, or medically inoperable pancreatic cancer: a phase II trial. J Gastrointest Oncol. 2022 Jun;13(3):1395-1401. doi: 10.21037/jgo-21-593.
Related Links
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Contact the University of Florida Proton Therapy Institute
Other Identifiers
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UFPTI-1510-PC04
Identifier Type: OTHER
Identifier Source: secondary_id
PAN009-18
Identifier Type: -
Identifier Source: org_study_id
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