Proton Therapy for Chordoma and Chondrosarcoma

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abramson Cancer Center at Penn Medicine

Disqualifiers: Prior malignancies, Pregnant, Other sarcomas, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores proton therapy as a treatment for chordomas and chondrosarcomas, rare tumors that can occur in the skull and spine. Researchers aim to determine the effectiveness of proton therapy, its side effects, and long-term patient outcomes after treatment. Suitable candidates for this trial have been diagnosed with chordoma or chondrosarcoma, with tumors in the skull or spine, and no evidence of metastatic disease. As an unphased trial, this study offers patients the chance to contribute to groundbreaking research on a potentially effective treatment for rare tumors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that proton therapy is safe for treating chordomas and chondrosarcomas?

Research has shown that proton therapy has been studied for its safety in treating chordomas and chondrosarcomas. One study examined patients with these tumors at the base of the skull who received proton therapy, and the results suggested it was well-tolerated. Most patients did not experience severe side effects. Another study investigated high-dose proton therapy and found it safe for these tumors, with only mild to moderate side effects reported.

Additionally, research on proton therapy for spinal tumors suggests it can be delivered safely and effectively. This indicates that proton therapy is generally considered a safe treatment option, with many patients handling it well. While side effects can occur, they are usually not severe. For those considering joining a trial, this evidence provides insight into the safety of proton therapy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Proton therapy is unique because it uses positively charged particles, protons, to target chordomas and chondrosarcomas more precisely than traditional radiation therapies, like X-rays. Unlike standard radiation, proton therapy can deliver high doses directly to the tumor with minimal damage to surrounding healthy tissue. This precision reduces potential side effects and allows for higher radiation doses to be used, which could improve treatment effectiveness. Researchers are excited about proton therapy because it offers a more targeted approach, potentially leading to better outcomes and improved quality of life for patients with these rare tumors.

What evidence suggests that proton therapy might be an effective treatment for chordomas and chondrosarcomas?

Research has shown that proton therapy, which participants in this trial will receive, is a promising treatment for chordomas and chondrosarcomas, rare tumors located at the base of the skull. Studies have found that proton therapy effectively controls tumor growth and improves survival rates for patients with these conditions. It precisely targets tumors, protecting nearby healthy tissue and reducing side effects. Proton therapy is often chosen for skull-base tumors because it delivers high doses of radiation directly to the tumor while sparing important surrounding areas. Overall, evidence supports its use as a strong option for treating these challenging tumors. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults (18+) with confirmed chordoma or chondrosarcoma in the skull and spine, without metastatic disease. Participants must be fairly active (ECOG ≤2), have good bone marrow function, and not be pregnant. They can't join if they've had other cancers in the last two years or are on another treatment study.

Inclusion Criteria

My diagnosis is either chordoma or chondrosarcoma.

I can take care of myself and perform daily activities.

My blood tests show enough white cells and platelets.

Exclusion Criteria

My cancer did not start in my brain or spinal cord.

My cancer is not melanoma, sarcoma, giant cell tumor, or aneurismal bone cyst.

I have not had any cancer other than skin or thyroid cancer in the past 2 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Feasibility

Evaluate the feasibility and acute side effects of proton therapy for the first 12 participants

Up to 10 days

Phase II Treatment

Participants receive proton radiation therapy with a total dose of 72.00 to 79.2 Gy(RBE) in 40-44 fractions

8-9 weeks

Follow-up

Participants are monitored for acute and late toxicity, as well as clinical outcomes

90 days

What Are the Treatments Tested in This Trial?

Interventions

• Proton Therapy

Trial Overview The study tests proton therapy's feasibility and immediate side effects for treating chordomas and chondrosarcomas, as well as its effectiveness and long-term side effects over time.

How Is the Trial Designed?

Group I: Proton group Experimental Treatment 1 Intervention

Proton radiation total dose 72.00 to 79.2 Gy(RBE) in 40-44 fractions

Proton Therapy is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Proton Therapy for:

• Head and neck cancer
• Pediatric cancers
• Spine tumors
• Breast cancer
• Sarcoma
• Brain tumors
• Prostate cancer

Approved in European Union as Proton Therapy for:

• Head and neck cancer
• Pediatric cancers
• Spine tumors
• Breast cancer
• Sarcoma
• Brain tumors
• Prostate cancer

Approved in Canada as Proton Therapy for:

• Head and neck cancer
• Pediatric cancers
• Spine tumors
• Breast cancer
• Sarcoma
• Brain tumors
• Prostate cancer

Approved in Japan as Proton Therapy for:

• Head and neck cancer
• Pediatric cancers
• Spine tumors
• Breast cancer
• Sarcoma
• Brain tumors
• Prostate cancer

Who Is Running the Clinical Trial?

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

Abramson Cancer Center of the University of Pennsylvania

Lead Sponsor

Trials

360

Recruited

108,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8686536/

Proton therapy with a fixed beamline for skull-base ... This study presents an analysis (efficacy and toxicity) of outcomes in patients with skull-base chordomas or chondrosarcomas treated with a fixed horizontal ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2331518023001968

Clinical Outcomes Following Dose-Escalated Proton ... Purpose. To evaluate the effectiveness of external-beam proton therapy (PT) on local control and survival in patients with skull-base chordoma.

3. hopkinsmedicine.org hopkinsmedicine.org/news/articles/2020/10/proton-therapy-case-study-skull-base-tumors

Proton Therapy Case Study—Skull Base Tumors Proton therapy is the preferred form of adjuvant radiation for skull base tumors including chordomas and chondrosarcomas.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11381865/

Impact of Dosimetric Compromises on Early Outcomes ... Long-term outcomes of patients with skull-base low-grade chondrosarcoma and chordoma patients treated with pencil beam scanning proton therapy. Radiother ...

5. advancesradonc.org advancesradonc.org/article/S2452-1094(24)00019-8/fulltext

A Prospective Phase I/II Clinical Trial of High-Dose Proton ... The purpose of this study was to evaluate the feasibility and safety of dose-escalated proton beam therapy for treating chordomas and ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2452109424001453

Impact of Dosimetric Compromises on Early Outcomes ... Long-term outcomes of patients with skull-base low-grade chondrosarcoma and chordoma patients treated with pencil beam scanning proton therapy. Radiother ...

7. redjournal.org redjournal.org/article/S0360-3016(24)00507-8/abstract

Proton Therapy for Spinal Tumors: A Consensus Statement ... The purpose of this consensus statement was to summarize safe and optimal delivery of PBT for spinal tumors. Methods and Materials. The Particle ...

8. thegreenjournal.com thegreenjournal.com/article/S0167-8140(21)09016-2/pdf

Single-institution clinical experience using robust intensity ... Conclusions: Robustly optimized intensity modulated proton beam therapy for chordoma and chon- drosarcoma of the mobile spine is feasible ...