NCT00496522

Brief Summary

The goal of this clinical research study is to learn if proton beam therapy, with or without photon beam radiation therapy, is effective in the treatment of skull base chondrosarcoma. The safety of this treatment will also be studied.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
3mo left

Started Apr 2006

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress99%
Apr 2006Aug 2026

Study Start

First participant enrolled

April 28, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 4, 2007

Completed
19.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 19, 2026

Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

20.3 years

First QC Date

July 2, 2007

Last Update Submit

March 5, 2026

Conditions

Chondrosarcoma

Keywords

Skull Base ChondrosarcomaProton Beam TherapyChondrosarcomaCNS

Outcome Measures

Primary Outcomes (1)

  • Time to Local Recurrence

    Local recurrence defined as progression on magnetic resonance imaging (MRI) or CT if MRI is contraindicated.

    Baseline to local recurrence (evaluation every six months during estimated 5 year study)

Study Arms (1)

Proton Beam Therapy

OTHER

Proton Beam Therapy - A total dose of up to 70 CGE given at 2.0 CGE per daily fraction for 35 fractions.

Procedure: Proton Beam Therapy

Interventions

Proton Beam TherapyPROCEDURE

A total dose of up to 70 CGE given at 2.0 CGE per daily fraction for 35 fractions.

Proton Beam Therapy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologically confirmed Grade 1-3 chondrosarcoma of the skull base
  • Contrast enhanced postop MRI or CT if there is clinical contraindication for MRI of the skull base obtained with 90 days of study registration at M. D. Anderson
  • The patient has been assessed by MDACC skull base surgeons to have undergone maximal surgical debulking of disease
  • Karnofsky Performance status greater than or equal to 60
  • Signed informed consent

You may not qualify if:

  • Previous irradiation of the skull base
  • Documented evidence of disseminated metastatic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Chondrosarcoma

Interventions

Proton Therapy

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsSarcoma

Intervention Hierarchy (Ancestors)

Heavy Ion RadiotherapyRadiotherapyTherapeutics

Study Officials

  • David Grosshans, MD,PHD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2007

First Posted

July 4, 2007

Study Start

April 28, 2006

Primary Completion (Estimated)

August 19, 2026

Study Completion (Estimated)

August 19, 2026

Last Updated

March 9, 2026

Record last verified: 2026-03

Locations

US(1)