ChordomaPhase 1/2NCT00592748
Charged Particle RT for Chordomas and Chondrosarcomas of the Base of Skull or Cervical Spine
A Phase 1/2 study testing Charged Particle Radiation Therapy in people with Chordoma and Chondrosarcoma, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The primary purpose of this study is to determine if the administration of a higher dose would decrease the chance of tumor recurrence, compared to the risk of tumor recurrence with a lower dose. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chordoma, Chondrosarcoma
- What is being tested?
- Charged Particle Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 381 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 1999to May 2015
- Phase
- Phase 1/2
- 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
Who may be able to join
- Biopsy proven chordoma. Slides must be reviewed prior to randomization by the central review pathologist
- Sites: Intercranial (sphenoid, clivus, petrous, basio-occiput) or cervical spine
- Boost target volume less than or equal to 150
- 18 years of age or older
- Karnofsky Performance Status > 50
- Neurologic Function of I or II
- No evidence of metastases
Who cannot join
- Previous radiation to the head or neck that would compromise the ability to deliver the prescribed treatment
- Concurrent or prior malignancy unless disease free for 5 or more years
- Evidence of metastatic disease
- Diabetes mellitus
- Major medical illness or psychiatric impairments that in the opinion of the investigator, will prevent administration or completion of the protocol therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Randomized Study of Charged Particle RT for Chordomas and Chondrosarcomas of the Base of Skull or Cervical Spine
The primary purpose of this study is to determine if the administration of a higher dose would decrease the chance of tumor recurrence, compared to the risk of tumor recurrence with a lower dose. Most of the treatment will be given protons, but participants may receive a small portion of treatment with x-rays, because less radiation is given to the skin with x-rays. This study uses two slightly different doses of radiation It is not clear at this time which of the dose levels is better.
Read the detailed description
- Participants will be assigned to a dose level by random chance, like flipping a coin.
- A treatment plan will be determined by a treatment planning CT scan and will either involve 40-44 treatments or 37-40 treatments.
- Conditions
- Chordoma, Chondrosarcoma
- Being tested
- Charged Particle Radiation Therapy
- Keywords
- charged particle radiation therapy
- Medical subject headings
- Chordoma, Chondrosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Charged Particle Radiation TherapyRadiation
Radiation doses will be determined by planning CT
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | 40-44 Treatments Receives: Radiation: Charged Particle Radiation Therapy |
| Group 2 | Active comparator | 37-40 Treatments Receives: Radiation: Charged Particle Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Toxicity
Measured: 90 days
Secondary outcomes (3)
Establish local control rates for both dose schedules.
Measured: 5 years
To provide date to be used as the basis for choosing the dose of charged particle radiation for chordomas of the base of skull and the cervical spine.
Measured: 5 years
Late Toxicity
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2008 (estimated)
- Study startJun 1999
- Primary completionJul 2007
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ChordomaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 381 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Norbert J. Liebsch, M.D., Massachusetts General Hospital
- Investigators
- Norbert J. Liebsch, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00592748
- Sponsor's protocol ID
- 97-553
- Status last verified
- Jun 2017
- First submitted
- 28 Dec 2007
- Last updated
- 16 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ioakeim-Ioannidou M, Yeap BY, Soetan ZO, Kim DW, Packard D, Hegazy R, Todary ES, Tejada A, Adams J, Kooy H, Zieminski S, Depauw N, Nielsen GP, Hung YP, Rosenberg A, Tobert DG, Shankar G, Curry WT, Cote GM, Kelly HR, Cunnane ME, Chang YS, Gardner P, Giap F, Chen YL, Delaney TF, Hug E, Liu KX, Shih HA, MacDonald SM. Prospective, randomized dose-escalation trial with proton-based radiation for skull base and cervical spine chondrosarcomas: 30-year outcomes from PROG 85-26. Neuro Oncol. 2026 Apr 1;28(4):968-977. doi: 10.1093/neuonc/noaf289.
PubMed 41414803
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Charged Particle RT for Chordomas and Chondrosarcomas of the Base of Skull or Cervical Spine
- ClinicalTrials.gov ID
- NCT00592748
- Acronym / sponsor ID
- 97-553
- Conditions
- Chordoma, Chondrosarcoma
- Keywords
- charged particle radiation therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 381 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jun 1999
- Primary completion
- Jul 2007 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 14 Jan 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 primary purpose of this study is to determine if the administration of a higher dose would decrease the chance of tumor recurrence, compared to the risk of tumor recurrence with a lower dose. Most of the treatment will be given protons, but participants may receive a small portion of treatment with x-rays, because less radiation is given to the skin with x-rays. This study uses two slightly different doses of radiation It is not clear at this time which of the dose levels is better.
Detailed description
- Participants will be assigned to a dose level by random chance, like flipping a coin.
- A treatment plan will be determined by a treatment planning CT scan and will either involve 40-44 treatments or 37-40 treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Radiation: Charged Particle Radiation Therapy40-44 Treatments |
| Group 2 | Active comparator | Radiation: Charged Particle Radiation Therapy37-40 Treatments |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Biopsy proven chordoma. Slides must be reviewed prior to randomization by the central review pathologist
- Sites: Intercranial (sphenoid, clivus, petrous, basio-occiput) or cervical spine
- Boost target volume less than or equal to 150
- 18 years of age or older
- Karnofsky Performance Status > 50
Key exclusion criteria (5 listed)
- Previous radiation to the head or neck that would compromise the ability to deliver the prescribed treatment
- Concurrent or prior malignancy unless disease free for 5 or more years
- Evidence of metastatic disease
- Diabetes mellitus
- Major medical illness or psychiatric impairments that in the opinion of the investigator, will prevent administration or completion of the protocol therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Charged Particle Radiation TherapyRadiation doses will be determined by planning CT | Radiation | Group 1, Group 2 |
Primary outcome
Acute Toxicity
Time frame: 90 days
3 secondary outcomes
Establish local control rates for both dose schedules.
Time frame: 5 years
To provide date to be used as the basis for choosing the dose of charged particle radiation for chordomas of the base of skull and the cervical spine.
Time frame: 5 years
Late Toxicity
Time frame: 5 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 16 Jun 2017.
- Derived from this study: PubMed 41414803Ioakeim-Ioannidou M, Yeap BY, Soetan ZO, Kim DW, Packard D, Hegazy R, Todary ES, Tejada A, Adams J, Kooy H, Zieminski S, Depauw N, Nielsen GP, Hung YP, Rosenberg A, Tobert DG, Shankar G, Curry WT, Cote GM, Kelly HR, Cunnane ME, Chang YS, Gardner P, Giap F, Chen YL, Delaney TF, Hug E, Liu KX, Shih HA, MacDonald SM. Prospective, randomized dose-escalation trial with proton-based radiation for skull base and cervical spine chondrosarcomas: 30-year outcomes from PROG 85-26. Neuro Oncol. 2026 Apr 1;28(4):968-977. doi: 10.1093/neuonc/noaf289.
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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.
Norbert J. Liebsch, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Charged Particle Radiation Therapy in people with Chordoma and Chondrosarcoma, run by Massachusetts General Hospital 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 7 inclusion and 5 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 16 Jun 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Acute Toxicity (time frame: 90 days). 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 NCT00592748, which also lists 1 linked publication.
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 16 Jun 2017.