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

50 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Proton Therapy for Chordoma and Chondrosarcoma?

Research shows that proton therapy, including advanced forms like intensity-modulated proton therapy (IMPT), is effective for treating chordoma and chondrosarcoma, especially in challenging areas like the skull base and spine. Studies indicate that it can safely deliver higher doses of radiation to tumors while minimizing damage to surrounding healthy tissues. ^{1 2 3 4 5}

Is proton therapy safe for treating chordoma and chondrosarcoma?

Proton therapy, including its various forms like intensity-modulated proton therapy (IMPT), has been used in clinical trials for treating chordoma and chondrosarcoma, showing it can be administered safely. Studies have reported on its use in different parts of the body, such as the spine and skull base, with a focus on managing side effects and ensuring precise delivery of treatment. ^{1 2 4 6 7}

How is proton therapy different from other treatments for chordoma and chondrosarcoma?

Proton therapy is unique because it can deliver high doses of radiation more precisely to tumors like chordoma and chondrosarcoma, which are often located near critical structures, reducing damage to surrounding healthy tissue. This makes it particularly effective for tumors that are considered radioresistant and require high radiation doses. ^{1 2 4 8 9}

What is the purpose of this trial?

The objectives of this study are 1) To evaluate the feasibility and acute side effects of proton therapy for chordomas and chondrosarcomas and 2) To evaluate clinical outcomes and long term side effects of proton beam radiation for treatment of chordomas and chondrosarcomas.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Postoperative spot-scanning proton radiation therapy for chordoma and chondrosarcoma in children and adolescents: initial experience at paul scherrer institute. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A prospective clinical trial of proton therapy for chordoma and chondrosarcoma: Feasibility assessment. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Spot-scanning proton radiation therapy for pediatric chordoma and chondrosarcoma: clinical outcome of 26 patients treated at paul scherrer institute. [2018]

4. Ireland pubmed.ncbi.nlm.nih.gov

Single-institution clinical experience using robust intensity modulated proton therapy in chordoma and chondrosarcoma of the mobile spine and sacrum: Feasibility and need for plan adaptation. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Results of spot-scanning proton radiation therapy for chordoma and chondrosarcoma of the skull base: the Paul Scherrer Institut experience. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Proton therapy with a fixed beamline for skull-base chordomas and chondrosarcomas: outcomes and toxicity. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Dramatic Response of a Large Sacral Chordoma to Intensity Modulated Proton Beam Therapy. [2020]

8. India pubmed.ncbi.nlm.nih.gov

Introduction of Image‑Guided Pencil Beam for Skull Base Tumors in India: A Report of Two Cases and a Brief Review of the Literature. [2020]

9. England pubmed.ncbi.nlm.nih.gov

The preliminary results of proton and carbon ion therapy for chordoma and chondrosarcoma of the skull base and cervical spine. [2020]