Exploring personalized biomarkers during radiation therapy for chordoma
Exploration of Personalized Biomarkers During Neoadjuvant Radiation Therapy for Spinal and Sacral Chordoma
This study is testing if tracking changes in tumor DNA during radiation therapy can help doctors better understand how chordoma patients are responding to treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Baltimore, Maryland and 1 other locations) |
| Trial ID | NCT06463262 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the effects of neoadjuvant radiation therapy, specifically proton therapy and stereotactic body radiation therapy, on circulating tumor DNA (ctDNA) and radiographic changes in patients with chordoma. The goal is to determine if these biomarkers can provide insights into the histopathologic response to radiation therapy. By comparing these findings to the current gold standard of pathologic results, the study aims to enhance diagnostic accuracy and treatment planning for chordoma patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed chordoma of the skull base, spine, or sacrum who are scheduled for neoadjuvant radiation therapy.
Not a fit: Patients with chordoma who are not candidates for neoadjuvant radiation therapy or those with a Karnofsky Performance Score below 40 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic tools for predicting treatment responses in chordoma patients.
How similar studies have performed: While the approach of using ctDNA and radiomics in this context is innovative, similar studies have shown promise in other cancer types, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Baltimore, Maryland and 1 other locations
- Johns Hopkins Hospital — Baltimore, Maryland, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Kristin Redmond, MD, MPH — Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Study coordinator: Kristin Redmond, MD, MPH
- Email: kjanson3@jhmi.edu
- Phone: 4106141642
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.