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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Local Tumor Control
Secondary outcome measures
Functional Status
Number of Participants with Acute and Late Normal Tissue Toxicity scored according to the CTCAE
Sites of Failure
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
13,654 Previous Clinical Trials
40,933,089 Total Patients Enrolled
18 Trials studying Chondrosarcoma
1,528 Patients Enrolled for Chondrosarcoma
Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,198,291 Total Patients Enrolled
1 Trials studying Chondrosarcoma
381 Patients Enrolled for Chondrosarcoma
M.D. Anderson Cancer CenterOTHER
2,966 Previous Clinical Trials
1,804,717 Total Patients Enrolled
3 Trials studying Chondrosarcoma
99 Patients Enrolled for Chondrosarcoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had radiation on my skull base, spine, or sacrum but may have had chemotherapy recently.My organs and bone marrow are functioning normally.I agree to use birth control during the study.My cancer has spread to other parts of my body.I do not have any severe illnesses or conditions that would interfere with the study.My cancer may not be measurable, and it could be a new or returning growth.My tumor has been biopsied or partially removed, and I may need more treatment.I can care for myself and am up and about more than 50% of my waking hours.I have neurological issues not caused by my tumor's growth or its metabolic effects.I am HIV-positive and on combination antiretroviral therapy.I am 18 years old or older.My cancer has not spread to distant parts of my body.I had cancer before, but it's been 5 years and I'm now cancer-free, or it was a minor skin cancer or early-stage cervical cancer treated within the last 5 years.My cancer diagnosis is either chondrosarcoma or chordoma in specific areas and confirmed by a participating institution.
Research Study Groups:
This trial has the following groups:- Group 1: IMPT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there currently an open call for participants in this trial?
"According to the information published on clinicaltrials.gov, this medical study is not presently accepting patients; it was initially posted in December 2012 and updated last September 2020. Despite no longer being open for enrollment, 474 other trials are currently recruiting individuals."
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