Proton Beam Therapy for Chordoma Patients

M.D. Anderson Cancer Center

Status and phase: Active, not recruiting; Phase 2

Conditions: Chordoma

Treatments: Radiation: Photon Beam Therapy; Radiation: Proton Beam Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00496119

2005-0038

NCI-2012-01509 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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19 participants in 2 patient groups

70 Gray (Gy) Proton Beam Therapy

Experimental group

Description:

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

Treatment:

Radiation: Proton Beam Therapy

Photon Beam Therapy

Experimental group

Description:

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

Treatment:

Radiation: Proton Beam Therapy

Radiation: Photon Beam Therapy