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Proton Beam Therapy
Proton Therapy for Chordoma and Chondrosarcoma
N/A
Waitlist Available
Research Sponsored by Abramson Cancer Center at Penn Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years
Histologically confirmed diagnosis of chordoma or chondrosarcoma
Must not have
Tumors arising outside of the CNS
Histologies excluded: melanoma, other soft tissue or bony sarcomas, giant cell tumor aneurismal bone cyst, or metastatic lesions from other histologies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether proton therapy is a safe and effective treatment for chordomas and chondrosarcomas.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects aren't listed here, proton therapy may include skin reactions at the treatment site, fatigue, headaches, hair loss near treated areas, nausea or hearing changes depending on tumor location.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My diagnosis is either chordoma or chondrosarcoma.
Select...
I can take care of myself and perform daily activities.
Select...
My scans show no signs of cancer spread.
Select...
My blood tests show enough white cells and platelets.
Select...
My cancer originates in my skull or spine.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My cancer did not start in my brain or spinal cord.
Select...
My cancer is not melanoma, sarcoma, giant cell tumor, or aneurismal bone cyst.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acute Toxicity
Chondrosarcoma
Secondary study objectives
Late toxicity
Side effects data
From 2022 Phase 1 & 2 trial • 40 Patients • NCT0183983861%
Skin hyperpigmentation
29%
Localized edema
29%
Telangiectasia
11%
Superficial soft tissue fibrosis
7%
Pruritus
7%
Erythema
7%
Dermatitis radiation
7%
Fatigue
7%
Fibrosis of breast
7%
Dry skin
4%
Respiratory failure
4%
Enterocolitis infectious
4%
Generalized muscle weakness
4%
Intracranial hemorrhage
4%
Non-cardiac chest pain
4%
Reproductive system and breast disorders - Other, specify
4%
Sepsis
4%
Small intestine ulcer
4%
Breast pain
4%
Breast pigment change
4%
Chest pain
4%
Syncope
4%
Breast edema
4%
burning sensation of skin
4%
Breast tenderness
4%
Skin hypopigmentation
4%
Fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
APBI With Protons Phase 2
APBI With Protons Phase 1
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: Proton groupExperimental Treatment1 Intervention
Proton radiation total dose 72.00 to 79.2 Gy(RBE) in 40-44 fractions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Proton Therapy
2013
Completed Phase 2
~320
Find a Location
Who is running the clinical trial?
Abramson Cancer Center at Penn MedicineLead Sponsor
413 Previous Clinical Trials
164,581 Total Patients Enrolled
Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
108,454 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.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.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.I am a woman who can have children and agree to use birth control.My cancer originates in my skull or spine.My scans show no signs of cancer spread.My tumor is located in my skull or spine.
Research Study Groups:
This trial has the following groups:- Group 1: Proton group
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.
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