Proton Beam Therapy for Chordoma Patients

Chordoma Clinical Trial

Official title:

Phase II Evaluation of Proton Beam Therapy for Skull Base Chordoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00496119
• Other study ID #: 2005-0038
• Secondary ID: NCI-2012-01509
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: September 18, 2006
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Proton therapy is a kind of external beam radiation therapy where protons are directed to a tumor site. Researchers are trying to determine what level of proton therapy gives the most benefit without causing toxic side effects. Researchers will also be testing the treatment's effect. If your doctor feels it is necessary, the proton beam therapy may be combined with standard photon therapy. If you are eligible to take part in this study, you will receive proton beam therapy at The University of Texas (UT) MD Anderson Cancer Center (MDACC), and possibly photon beam, no sooner than 2 weeks after the last surgery to remove the tumor. You will receive proton beam therapy once a day for about 35 treatments (7 weeks). Treatment will be given for 5 days in a row each week (except for Saturdays, Sundays and holidays) at the MDACC Proton Center in Houston. The whole process should take up to 1 hour each day. This is an investigational study. The proton beam machine used to deliver treatment is approved by the FDA for patient use. The doses being studied are experimental. About 15 participants will take part in this study. All will be enrolled at MDACC.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 19
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Pathologically confirmed chordoma of the skull base

2. Contrast enhanced postoperative MRI (CT in case MRI is contraindicated) of the skull base obtained within 90 days of study registration

3. MDACC surgeons have determined that optimal debulking of disease has been performed.

4. Karnofsky Performance status greater than or equal to 60

5. Signed informed consent

Exclusion Criteria:

1. Previous irradiation of the skull base

2. Documented evidence of disseminated metastatic disease

3. Any concurrent malignancy (other than non-melanoma skin cancers) in the last 3 years

Related Conditions & MeSH terms

• Chordoma

Intervention

Radiation:
• Proton Beam Therapy
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.
• Photon Beam Therapy
Photon beam therapy once daily, no sooner than 2 weeks after last surgery to remove tumor, for 35-39 treatments.

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   MD Anderson Cancer Center