ChordomasCH01NCT00797602
Proton Therapy for Chordomas and/or Chondrosarcomas
An observational study of Chordomas and Chondrosarcomas, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chordomas, Chondrosarcomas
- How many people
- 189 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated at a radiation oncology clinic
Who may be able to join
- Histologically proven chordoma or chondrosarcoma.
- Sites: base of skull and/or spine.
- Age 18 years or older.
Who cannot join
- Previous radiation to the head and neck or brain.
- Evidence of metastatic disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida Proton Therapy Institute
Jacksonville, Florida, 32206
About this study
Official title: A Clinical Outcomes Protocol of Proton Beam Radiation Therapy for Chordomas and/or Chondrosarcomas of the Base of Skull and/or Spine
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.
Read the detailed description
Data collection will be obtained from the patient's medical records including initial evaluation, pathology report, dosimetry information, radiotherapy completion records and follow-up.
- Conditions
- Chordomas, Chondrosarcomas
- Keywords
- Chordomas, Chondrosarcomas, Cancer, Outcomes, Proton radiation
- Medical subject headings
- Chordoma, Chondrosarcoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Proton Radiation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collect and analyze outcome data on tumor control.
Measured: 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.
Specifically analyzing pituitary, visual and hearing function.
Measured: When each patient has been followed for a minimum of 12 months and then again after 24 months to a maximum of 10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2008 (estimated)
- Study startJan 2007
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for ChordomasStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronny L Rotondo, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00797602
- Sponsor's protocol ID
- UFPTI 0607-CH01
- Acronym
- CH01
- Status last verified
- Aug 2017
- First submitted
- 24 Nov 2008
- Last updated
- 14 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 11227920Dahlin DC, Unni KK: Bone tumors general aspects and data on 8542 cases, 4th edition. Springfield, IL: Charles C Thomas, 1986, pp 119 - 140.
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.
PubMed 7359980al-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.
PubMed 9010416Pearlman AW, Friedman M. Radical radiation therapy of chordoma. Am J Roentgenol Radium Ther Nucl Med. 1970 Feb;108(2):332-41. No abstract available.
PubMed 4983924Mendenhall 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.
PubMed 15641104Fuller 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.
PubMed 2457005Catton 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.
PubMed 8961370Terahara 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.
PubMed 10487555O'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.
PubMed 7922977Noel 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.
PubMed 12707713Berson 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.
PubMed 3138208Hug 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.
PubMed 11958897Austin 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.
PubMed 8436522Fagundes 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.
PubMed 7558946
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Outcomes Protocol of Proton Beam Radiation Therapy for Chordomas and/or Chondrosarcomas of the Base of Skull and/or Spine
- ClinicalTrials.gov ID
- NCT00797602
- Acronym / sponsor ID
- CH01 / UFPTI 0607-CH01
- Conditions
- Chordomas, Chondrosarcomas
- Keywords
- Chordomas, Chondrosarcomas, Cancer, Outcomes, Proton radiation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 25 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Data collection will be obtained from the patient's medical records including initial evaluation, pathology report, dosimetry information, radiotherapy completion records and follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proton Radiation | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated at a radiation oncology clinic
Key inclusion criteria (3 listed)
- Histologically proven chordoma or chondrosarcoma.
- Sites: base of skull and/or spine.
- Age 18 years or older.
Key exclusion criteria (2 listed)
- Previous radiation to the head and neck or brain.
- Evidence of metastatic disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Collect and analyze outcome data on tumor control.
Time frame: When each patient has been followed for a minimum of 12 month and then again after 24 months to a maximum of 10 years.
1 secondary outcome
Collect and analyze data on normal tissue morbidity.
Time frame: When each patient has been followed for a minimum of 12 months and then again after 24 months to a maximum of 10 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2017.
- Background: PubMed 11227920McMaster 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.
- BackgroundDahlin DC, Unni KK: Bone tumors general aspects and data on 8542 cases, 4th edition. Springfield, IL: Charles C Thomas, 1986, pp 119 - 140.
- Background: PubMed 7359980Campbell 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.
- Background: PubMed 9010416al-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.
- Background: PubMed 4983924Pearlman AW, Friedman M. Radical radiation therapy of chordoma. Am J Roentgenol Radium Ther Nucl Med. 1970 Feb;108(2):332-41. No abstract available.
- Background: PubMed 15641104Mendenhall 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.
- Background: PubMed 2457005Fuller 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.
- Background: PubMed 8961370Catton 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.
- Background: PubMed 10487555Terahara 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.
- Background: PubMed 7922977O'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.
- Background: PubMed 12707713Noel 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.
- Background: PubMed 3138208Berson 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronny L Rotondo, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chordomas and Chondrosarcomas, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collect and analyze outcome data on tumor control. (time frame: When each patient has been followed for a minimum of 12 month and then again after 24 months to a maximum of 10 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00797602, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2017.