NCT00685763

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable pancreatic-cancer

Timeline
Completed

Started Mar 2008

Longer than P75 for not_applicable pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 28, 2008

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
9 months until next milestone

Results Posted

Study results publicly available

July 3, 2014

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2017

Completed
Last Updated

August 24, 2017

Status Verified

July 1, 2017

Enrollment Period

5.6 years

First QC Date

May 22, 2008

Results QC Date

May 23, 2014

Last Update Submit

July 21, 2017

Conditions

Pancreatic Cancer

Keywords

Pancreatic cancerUnresectableProton radiationChemotherapy

Outcome Measures

Primary Outcomes (1)

  • 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)

    1 year following the completion of radiation therapy

Secondary Outcomes (1)

  • Collect and Analyze Tumor Control Measures

    1 year following the completion of radiation therapy

Study Arms (1)

Proton radiation and chemotherapy

EXPERIMENTAL

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.

Radiation: Proton radiation and chemotherapy

Interventions

Proton radiation and chemotherapyRADIATION

Proton radiation 59.4 CGE in 33 fx at 1.8 CGE per fx over 7 weeks . Chemotherapy: Capecitabine (Xeloda ®) 1,000 mg by mouth twice a day, 5 days/week (M-F) Consolidation Chemotherapy: Suggested Regimen - Gemcitabine total of 12 doses

Also known as: Capecitabine, Xeloda, Gemcitabine, Gemzar
Proton radiation and chemotherapy

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologically confirmed adenocarcinoma of the pancreas.
  • Patients must be medically inoperable or have unresectable disease

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida Proton Therapy Institute

Jacksonville, Florida, 32206, United States

Location

Related Publications (21)

  • Saif 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: 16832131BACKGROUND

  • Seydel 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: 2138054BACKGROUND

  • Schuster-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: 3809584BACKGROUND

  • Ueno 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: 15557781BACKGROUND

  • Ben-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: 15145162BACKGROUND

  • Hsiung-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: 11704461BACKGROUND

  • Mackean 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.

    PMID: 9738566BACKGROUND

  • Hoff PM, Ansari R, Batist G, Cox J, Kocha W, Kuperminc M, Maroun J, Walde D, Weaver C, Harrison E, Burger HU, Osterwalder B, Wong AO, Wong R. Comparison of oral capecitabine versus intravenous fluorouracil plus leucovorin as first-line treatment in 605 patients with metastatic colorectal cancer: results of a randomized phase III study. J Clin Oncol. 2001 Apr 15;19(8):2282-92. doi: 10.1200/JCO.2001.19.8.2282.

    PMID: 11304782BACKGROUND

  • Dunst J, Reese T, Sutter T, Zuhlke H, Hinke A, Kolling-Schlebusch K, Frings S. Phase I trial evaluating the concurrent combination of radiotherapy and capecitabine in rectal cancer. J Clin Oncol. 2002 Oct 1;20(19):3983-91. doi: 10.1200/JCO.2002.02.049.

    PMID: 12351595BACKGROUND

  • Bussels B, Goethals L, Feron M, Bielen D, Dymarkowski S, Suetens P, Haustermans K. Respiration-induced movement of the upper abdominal organs: a pitfall for the three-dimensional conformal radiation treatment of pancreatic cancer. Radiother Oncol. 2003 Jul;68(1):69-74. doi: 10.1016/s0167-8140(03)00133-6.

    PMID: 12885454BACKGROUND

  • Eccles C, Brock KK, Bissonnette JP, Hawkins M, Dawson LA. Reproducibility of liver position using active breathing coordinator for liver cancer radiotherapy. Int J Radiat Oncol Biol Phys. 2006 Mar 1;64(3):751-9. doi: 10.1016/j.ijrobp.2005.05.066.

    PMID: 16458774BACKGROUND

  • Korreman SS, Pedersen AN, Nottrup TJ, Specht L, Nystrom H. Breathing adapted radiotherapy for breast cancer: comparison of free breathing gating with the breath-hold technique. Radiother Oncol. 2005 Sep;76(3):311-8. doi: 10.1016/j.radonc.2005.07.009.

    PMID: 16153728BACKGROUND

  • Sugahara S, Tokuuye K, Okumura T, Nakahara A, Saida Y, Kagei K, Ohara K, Hata M, Igaki H, Akine Y. Clinical results of proton beam therapy for cancer of the esophagus. Int J Radiat Oncol Biol Phys. 2005 Jan 1;61(1):76-84. doi: 10.1016/j.ijrobp.2004.04.003.

    PMID: 15629597BACKGROUND

  • Bush DA, Hillebrand DJ, Slater JM, Slater JD. High-dose proton beam radiotherapy of hepatocellular carcinoma: preliminary results of a phase II trial. Gastroenterology. 2004 Nov;127(5 Suppl 1):S189-93. doi: 10.1053/j.gastro.2004.09.033.

    PMID: 15508084BACKGROUND

  • Gierga DP, Chen GT, Kung JH, Betke M, Lombardi J, Willett CG. Quantification of respiration-induced abdominal tumor motion and its impact on IMRT dose distributions. Int J Radiat Oncol Biol Phys. 2004 Apr 1;58(5):1584-95. doi: 10.1016/j.ijrobp.2003.09.077.

    PMID: 15050340BACKGROUND

  • Wong JW, Sharpe MB, Jaffray DA, Kini VR, Robertson JM, Stromberg JS, Martinez AA. The use of active breathing control (ABC) to reduce margin for breathing motion. Int J Radiat Oncol Biol Phys. 1999 Jul 1;44(4):911-9. doi: 10.1016/s0360-3016(99)00056-5.

    PMID: 10386650BACKGROUND

  • Singh AK, Tierney RM, Low DA, Parikh PJ, Myerson RJ, Deasy JO, Wu CS, Pereira GC, Wahab SH, Mutic S, Grigsby PW, Hope AJ. A prospective study of differences in duodenum compared to remaining small bowel motion between radiation treatments: implications for radiation dose escalation in carcinoma of the pancreas. Radiat Oncol. 2006 Sep 4;1:33. doi: 10.1186/1748-717X-1-33.

    PMID: 16952315BACKGROUND

  • Blackall JM, Ahmad S, Miquel ME, McClelland JR, Landau DB, Hawkes DJ. MRI-based measurements of respiratory motion variability and assessment of imaging strategies for radiotherapy planning. Phys Med Biol. 2006 Sep 7;51(17):4147-69. doi: 10.1088/0031-9155/51/17/003. Epub 2006 Aug 8.

    PMID: 16912374BACKGROUND

  • Fishman B, Pasternak S, Wallenstein SL, Houde RW, Holland JC, Foley KM. The Memorial Pain Assessment Card. A valid instrument for the evaluation of cancer pain. Cancer. 1987 Sep 1;60(5):1151-8. doi: 10.1002/1097-0142(19870901)60:53.0.co;2-g.

    PMID: 3300951BACKGROUND

  • Varadhachary GR, Tamm EP, Abbruzzese JL, Xiong HQ, Crane CH, Wang H, Lee JE, Pisters PW, Evans DB, Wolff RA. Borderline resectable pancreatic cancer: definitions, management, and role of preoperative therapy. Ann Surg Oncol. 2006 Aug;13(8):1035-46. doi: 10.1245/ASO.2006.08.011. Epub 2006 Jul 24.

    PMID: 16865597BACKGROUND

  • NCCN (National Comprehensive Cancer Network) Clinical Practice Guidelines in Oncology. V.2.2006.

    BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Drug TherapyCapecitabineGemcitabine

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

Title
Charles Nichols, M.D.
Organization
University of Florida Proton Therapy Institute
rnichols@floridaproton.org
904-588-1800

Study Officials

  • R. Charles Nichols, MD

    University of Florida Proton Therapy Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2008

First Posted

May 28, 2008

Study Start

March 1, 2008

Primary Completion

October 1, 2013

Study Completion

June 29, 2017

Last Updated

August 24, 2017

Results First Posted

July 3, 2014

Record last verified: 2017-07

Locations

US(1)