Proton Beam Therapy for Chordoma Patients

NCT00496119 | Active Not Recruiting Phase 2 DMC

• 2 other identifiers: 2005-0038NCI-2012-01509
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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 chordoma. The safety of this treatment will also be studied.

Conditions

Chordoma

Keywords

Proton Beam Therapy; Skull Base Chordoma; Chordoma of the Skull Base; Chordoma

Outcome Measures

Primary Outcomes (1)

• Time to Local Recurrence

  Recurrence classified as "central," "in-field", "marginal," "peripheral," or "distant" depending upon its relationship to the dose distribution on the original treatment plan. MRI (or CT in case MRI is contraindicated) of the skull base used to document the status of disease in the following categories: 1) stable disease, 2) progressive disease, 3) partial response/complete response. A post-operative MRI (or CT) obtained within 90 days of study registration serves as baseline with annual follow up till disease progression or death for any reason.

  1 year after radiation treatments

Study Arms (2)

70 Gray (Gy) Proton Beam Therapy

EXPERIMENTAL

Participants treated to 70 cobalt Gray equivalent (CGE) only (the standard treatment).

Radiation: Proton Beam Therapy

Photon Beam Therapy

EXPERIMENTAL

Proton beam therapy combined with photon radiation therapy where combination improves final dose distribution.

Radiation: Proton Beam Therapy; Radiation: Photon Beam Therapy

Interventions

Proton Beam Therapy RADIATION

70 Gy once daily at 2 CGE per fraction, no sooner than 2 weeks after last surgery to remove tumor, for between 35-39 treatments.

70 Gray (Gy) Proton Beam Therapy; Photon Beam Therapy

Photon Beam Therapy RADIATION

Photon beam therapy once daily, no sooner than 2 weeks after last surgery to remove tumor, for 35-39 treatments.

Photon Beam Therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically confirmed chordoma of the skull base
• Contrast enhanced postoperative MRI (CT in case MRI is contraindicated) of the skull base obtained within 90 days of study registration
• MDACC surgeons have determined that optimal debulking of disease has been performed.
• 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
• Any concurrent malignancy (other than non-melanoma skin cancers) in the last 3 years

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Chordoma

Interventions

Proton Therapy

Condition Hierarchy (Ancestors)

Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Heavy Ion Radiotherapy; Radiotherapy; Therapeutics

Study Officials

• David Grosshans, MD, PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2007
• First Posted: July 4, 2007
• Study Start: September 18, 2006
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

US (1)