Proton Beam Therapy for Chordoma Patients

• ClinicalTrials.gov Identifier: NCT00496119
• Recruitment Status: Active, not recruiting
• First Posted: July 4, 2007
• Last Update Posted: December 7, 2022
• Sponsor: M.D. Anderson Cancer Center
• Information provided by (Responsible Party): M.D. Anderson Cancer Center

Tracking Information

• First Submitted Date: July 2, 2007
• First Posted Date: July 4, 2007
• Last Update Posted Date: December 7, 2022
• Actual Study Start Date: September 2006
• Estimated Primary Completion Date: December 31, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 15, 2015)

Time to Local Recurrence [ Time Frame: 1 year after radiation treatments ]

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.

• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Proton Beam Therapy for Chordoma Patients
• Official Title: Phase II Evaluation of Proton Beam Therapy for Skull Base Chordoma
• 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.

Detailed 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.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: 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.
• Radiation: Photon Beam Therapy
  Photon beam therapy once daily, no sooner than 2 weeks after last surgery to remove tumor, for 35-39 treatments.

Study Arms

• Experimental: 70 Gray (Gy) Proton Beam Therapy
  Participants treated to 70 cobalt Gray equivalent (CGE) only (the standard treatment).
  Intervention: Radiation: Proton Beam Therapy
• Experimental: Photon Beam Therapy
  Proton beam therapy combined with photon radiation therapy where combination improves final dose distribution.
  Interventions:

  • Radiation: Proton Beam Therapy
  • Radiation: Photon Beam Therapy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: May 26, 2022): 19
• Original Estimated Enrollment (submitted: July 2, 2007): 75
• Estimated Study Completion Date: December 31, 2024
• Estimated Primary Completion Date: December 31, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00496119
• Other Study ID Numbers: 2005-0038; NCI-2012-01509 ( Registry Identifier: NCI CTRP )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: M.D. Anderson Cancer Center
• Original Responsible Party: Not Provided
• Current Study Sponsor: M.D. Anderson Cancer Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: David Grosshans, MD, PHD; M.D. Anderson Cancer Center

• PRS Account: M.D. Anderson Cancer Center
• Verification Date: November 2022