NCT00797602

Brief Summary

The purpose of this study is to collect information from medical records to see what effects proton beam radiation has on cancer and analyze possible side effects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
189

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

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

January 1, 2007

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 25, 2008

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

August 14, 2017

Status Verified

August 1, 2017

Enrollment Period

8.9 years

First QC Date

November 24, 2008

Last Update Submit

August 10, 2017

Conditions

ChordomasChondrosarcomas

Keywords

ChordomasChondrosarcomasCancerOutcomesProton radiation

Outcome Measures

Primary Outcomes (1)

  • Collect and analyze outcome data on tumor control.

    When each patient has been followed for a minimum of 12 month and then again after 24 months to a maximum of 10 years.

Secondary Outcomes (1)

  • Collect and analyze data on normal tissue morbidity.

    When each patient has been followed for a minimum of 12 months and then again after 24 months to a maximum of 10 years.

Study Arms (1)

Proton Radiation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients treated at a radiation oncology clinic

You may qualify if:

  • Histologically proven chordoma or chondrosarcoma.
  • Sites: base of skull and/or spine.
  • Age 18 years or older.

You may not qualify if:

  • Previous radiation to the head and neck or brain.
  • Evidence of metastatic disease.

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 (18)

  • McMaster ML, Goldstein AM, Bromley CM, Ishibe N, Parry DM. Chordoma: incidence and survival patterns in the United States, 1973-1995. Cancer Causes Control. 2001 Jan;12(1):1-11. doi: 10.1023/a:1008947301735.

    PMID: 11227920BACKGROUND

  • Dahlin DC, Unni KK: Bone tumors general aspects and data on 8542 cases, 4th edition. Springfield, IL: Charles C Thomas, 1986, pp 119 - 140.

    BACKGROUND

  • Campbell WM, McDonald TJ, Unni KK, Laws ER Jr. Nasal and paranasal presentations of chordomas. Laryngoscope. 1980 Apr;90(4):612-8. doi: 10.1288/00005537-198004000-00007.

    PMID: 7359980BACKGROUND

  • al-Mefty O, Borba LA. Skull base chordomas: a management challenge. J Neurosurg. 1997 Feb;86(2):182-9. doi: 10.3171/jns.1997.86.2.0182.

    PMID: 9010416BACKGROUND

  • Pearlman AW, Friedman M. Radical radiation therapy of chordoma. Am J Roentgenol Radium Ther Nucl Med. 1970 Feb;108(2):332-41. No abstract available.

    PMID: 4983924BACKGROUND

  • Mendenhall WM, Mendenhall CM, Lewis SB, Villaret DB, Mendenhall NP. Skull base chordoma. Head Neck. 2005 Feb;27(2):159-65. doi: 10.1002/hed.20144.

    PMID: 15641104BACKGROUND

  • Fuller DB, Bloom JG. Radiotherapy for chordoma. Int J Radiat Oncol Biol Phys. 1988 Aug;15(2):331-9. doi: 10.1016/s0360-3016(98)90012-8.

    PMID: 2457005BACKGROUND

  • Catton C, O'Sullivan B, Bell R, Laperriere N, Cummings B, Fornasier V, Wunder J. Chordoma: long-term follow-up after radical photon irradiation. Radiother Oncol. 1996 Oct;41(1):67-72. doi: 10.1016/s0167-8140(96)91805-8.

    PMID: 8961370BACKGROUND

  • Terahara A, Niemierko A, Goitein M, Finkelstein D, Hug E, Liebsch N, O'Farrell D, Lyons S, Munzenrider J. Analysis of the relationship between tumor dose inhomogeneity and local control in patients with skull base chordoma. Int J Radiat Oncol Biol Phys. 1999 Sep 1;45(2):351-8. doi: 10.1016/s0360-3016(99)00146-7.

    PMID: 10487555BACKGROUND

  • O'Connell JX, Renard LG, Liebsch NJ, Efird JT, Munzenrider JE, Rosenberg AE. Base of skull chordoma. A correlative study of histologic and clinical features of 62 cases. Cancer. 1994 Oct 15;74(8):2261-7. doi: 10.1002/1097-0142(19941015)74:83.0.co;2-0.

    PMID: 7922977BACKGROUND

  • Noel G, Habrand JL, Jauffret E, de Crevoisier R, Dederke S, Mammar H, Haie-Meder C, Pontvert D, Hasboun D, Ferrand R, Boisserie G, Beaudre A, Gaboriaud G, Guedea F, Petriz L, Mazeron JJ. Radiation therapy for chordoma and chondrosarcoma of the skull base and the cervical spine. Prognostic factors and patterns of failure. Strahlenther Onkol. 2003 Apr;179(4):241-8. doi: 10.1007/s00066-003-1065-5.

    PMID: 12707713BACKGROUND

  • Berson AM, Castro JR, Petti P, Phillips TL, Gauger GE, Gutin P, Collier JM, Henderson SD, Baken K. Charged particle irradiation of chordoma and chondrosarcoma of the base of skull and cervical spine: the Lawrence Berkeley Laboratory experience. Int J Radiat Oncol Biol Phys. 1988 Sep;15(3):559-65. doi: 10.1016/0360-3016(88)90295-7.

    PMID: 3138208BACKGROUND

  • Hug EB, Sweeney RA, Nurre PM, Holloway KC, Slater JD, Munzenrider JE. Proton radiotherapy in management of pediatric base of skull tumors. Int J Radiat Oncol Biol Phys. 2002 Mar 15;52(4):1017-24. doi: 10.1016/s0360-3016(01)02725-0.

    PMID: 11958897BACKGROUND

  • Austin JP, Urie MM, Cardenosa G, Munzenrider JE. Probable causes of recurrence in patients with chordoma and chondrosarcoma of the base of skull and cervical spine. Int J Radiat Oncol Biol Phys. 1993 Feb 15;25(3):439-44. doi: 10.1016/0360-3016(93)90065-4.

    PMID: 8436522BACKGROUND

  • Fagundes MA, Hug EB, Liebsch NJ, Daly W, Efird J, Munzenrider JE. Radiation therapy for chordomas of the base of skull and cervical spine: patterns of failure and outcome after relapse. Int J Radiat Oncol Biol Phys. 1995 Oct 15;33(3):579-84. doi: 10.1016/0360-3016(95)02014-3.

    PMID: 7558946BACKGROUND

  • Parsons JT, Bova FJ, Fitzgerald CR, Mendenhall WM, Million RR. Radiation optic neuropathy after megavoltage external-beam irradiation: analysis of time-dose factors. Int J Radiat Oncol Biol Phys. 1994 Nov 15;30(4):755-63. doi: 10.1016/0360-3016(94)90346-8.

    PMID: 7960976BACKGROUND

  • Parsons JT, Bova FJ, Fitzgerald CR, Mendenhall WM, Million RR. Radiation retinopathy after external-beam irradiation: analysis of time-dose factors. Int J Radiat Oncol Biol Phys. 1994 Nov 15;30(4):765-73. doi: 10.1016/0360-3016(94)90347-6.

    PMID: 7960977BACKGROUND

  • Bhandare N, Monroe AT, Morris CG, Bhatti MT, Mendenhall WM. Does altered fractionation influence the risk of radiation-induced optic neuropathy? Int J Radiat Oncol Biol Phys. 2005 Jul 15;62(4):1070-7. doi: 10.1016/j.ijrobp.2004.12.009.

    PMID: 15990010BACKGROUND

MeSH Terms

Conditions

ChordomaChondrosarcomaNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueSarcoma

Study Officials

  • Ronny L Rotondo, MD

    University of Florida Proton Therapy Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2008

First Posted

November 25, 2008

Study Start

January 1, 2007

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

August 14, 2017

Record last verified: 2017-08

Locations

US(1)