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Proton Beam Therapy

Intensity Modulated Proton Radiation for Brain & Spine Cancer

N/A
Waitlist Available
Led By Thomas F. DeLaney, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years of age or older
No clinical, radiographic or other evidence of distant metastasis
Must not have
Participants with metastases
Uncontrolled intercurrent illness including 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. Disease/conditions characterized by high radiation sensitivity. These include genetic diseases, such as ataxia telangiectasia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new way to give proton radiation therapy for tumors in the brain and spine. The new way, called intensity modulated proton radiation therapy (IMPT), may be more accurate and have fewer side effects than the standard proton radiation therapy.

Who is the study for?
This trial is for adults with chondrosarcoma or chordoma of the spine, sacrum, or base of skull. Candidates should not have had prior radiation in the affected area but may have had chemotherapy. They must be physically able to participate (ECOG 0-2), without distant metastasis, and agree to use contraception. Excluded are those with other cancers (unless disease-free for 5+ years or specific low-risk cases), brainstem/cord malfunction not caused by the tumor, uncontrolled illnesses, high radiation sensitivity conditions, pregnancy, or HIV on antiretrovirals.
What is being tested?
The study tests intensity modulated proton radiation treatment (IMPT) versus standard therapies like photon beam radiation. IMPT aims to target cancer more precisely while sparing healthy tissue and potentially reducing side effects compared to conventional methods. Participants will receive either IMPT alone or combined with surgical resection depending on their individual case.
What are the potential side effects?
Potential side effects include skin reactions at the treatment site, fatigue due to increased radiation dose even though it's targeted therapy; there might also be a risk of damage to surrounding healthy tissues leading to symptoms related to where the tumor is located such as neurological issues if near the spine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My cancer has not spread to distant parts of my body.
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I can care for myself and am up and about more than 50% of my waking hours.
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My cancer diagnosis is either chondrosarcoma or chordoma in specific areas and confirmed by a participating institution.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer has spread to other parts of my body.
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I do not have any severe illnesses or conditions that would interfere with the study.
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I have neurological issues not caused by my tumor's growth or its metabolic effects.
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I am HIV-positive and on combination antiretroviral therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Local Tumor Control
Secondary study objectives
Functional Status
Number of Participants with Acute and Late Normal Tissue Toxicity scored according to the CTCAE
Sites of Failure

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: IMPTExperimental Treatment1 Intervention
High dose IMPT

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,023,106 Total Patients Enrolled
12 Trials studying Chordoma
1,972 Patients Enrolled for Chordoma
Massachusetts General HospitalLead Sponsor
3,023 Previous Clinical Trials
13,317,885 Total Patients Enrolled
3 Trials studying Chordoma
430 Patients Enrolled for Chordoma
M.D. Anderson Cancer CenterOTHER
3,070 Previous Clinical Trials
1,802,744 Total Patients Enrolled
2 Trials studying Chordoma
34 Patients Enrolled for Chordoma
Thomas F. DeLaney, MDPrincipal InvestigatorMassachusetts General Hospital
3 Previous Clinical Trials
75 Total Patients Enrolled
1 Trials studying Chordoma
20 Patients Enrolled for Chordoma

Media Library

Intensity Modulated Proton Radiation Treatment (IMPT) (Proton Beam Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01346124 — N/A
Chordoma Research Study Groups: IMPT
Chordoma Clinical Trial 2023: Intensity Modulated Proton Radiation Treatment (IMPT) Highlights & Side Effects. Trial Name: NCT01346124 — N/A
Intensity Modulated Proton Radiation Treatment (IMPT) (Proton Beam Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01346124 — N/A
~5 spots leftby Dec 2025
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