Exploration of Personalized Biomarkers During Neoadjuvant Radiation Therapy for Spinal and Sacral Chordoma

NCT ID: NCT06463262

Last Updated: 2025-10-24

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-14
• Study Completion Date: 2031-07-31

Brief Summary

In this study the investigators will study the effects of neoadjuvant radiation therapy (RT), in the form of either proton therapy or stereotactic body radiation therapy (SBRT), on the Circulating tumor DNA (ctDNA), radiographic changes and radiomics, and the validity of these findings will be compared using the current gold standard- pathologic findings. The purpose of this work is to explore whether the biomarkers may be used diagnostically to better understand radiographic changes following RT. The investigators hypothesize that ctDNA levels in combination with imaging biomarkers identified through radiomics will be a sensitive and specific tool for predicting histopathologic response to RT.

Conditions

Chordoma of Spine; Chordoma of Skull Base; Chordoma of Sacrum

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Spinal, Sacral Chordoma

ctDNA

Intervention Type: DIAGNOSTIC_TEST

the effects of neoadjuvant RT, in the form of either proton therapy or SBRT, on the ctDNA

Interventions

ctDNA

the effects of neoadjuvant RT, in the form of either proton therapy or SBRT, on the ctDNA

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Age ≥18 years
• Histologically proven chordoma of the skull base, spine, or sacrum (coccyx lesions are eligible).
• Radiographic evidence of spinal sacral chordoma is required and may be obtained from computed tomography imaging and/or magnetic resonance imaging. Other studies may be used with principal investigator approval.

Note: Patients enrolled in Dr. Chetan Bettegowda's J1576 study, (IRB00075499) may be considered eligible for this trial. The J1576 study enrolls patients who have been diagnosed with Chordoma. Prior to enrollment, all patients must be consented specifically for participation in this Chordoma study (IRB00291203).

• Treating physician must deem that neoadjuvant proton therapy or SBRT is appropriate treatment for the chordoma.
• Surgical resection with curative intent must be planned.
• The patient must have a Karnofsky Performance Score of 40 or greater.
• If a woman is of child-bearing potential, a negative urine or serum pregnancy test must be demonstrated prior to treatment. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation and for up to 12 weeks following the study. Should a woman become pregnant or suspect she is pregnant while participating in this study she should inform her treating physician immediately.
• Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

• Prior radiation or radiosurgery to the involved level of the spine.
• Patients with metastatic disease will be excluded.
• Prior malignancies are excluded except for adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ, or other cancer from which the patient has been disease free for at least 1 year.
• Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements will be excluded.
• Pregnant women are excluded. Women of child-bearing potential who are unwilling or unable to use and acceptable method of birth control to avoid pregnancy for the entire study period and up to 12 weeks after the study are excluded. Male subjects must also agree to use effective contraception for the same period as above.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canon Medical Systems, USA

INDUSTRY

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristin Redmond, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status: RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kristin Redmond, MD, MPH

Role: CONTACT

kjanson3@jhmi.edu

4106141642

Jasmine Brooks, BA

Role: CONTACT

jbrook54@jhmi.edu

6673068335

Facility Contacts

Kristin Redmond, MD

Role: primary

kjanson3@jhmi.edu

410-955-6980

James Schuster, MD, PhD

Role: primary

james.schuster@pennmedicine.upenn.edu

215-294-9494

Other Identifiers

IRB00291203

Identifier Type: OTHER

Identifier Source: secondary_id

J2317

Identifier Type: -

Identifier Source: org_study_id