CLINICAL TRIAL

Proton Beam Radiation for Sarcoma

Waitlist Available · < 65 · All Sexes · Boston, MA

This study is evaluating whether proton beam radiation is safe for children with sarcomas.

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About the trial for Sarcoma

Eligible Conditions
Sarcoma · Non-rhabdomyosarcoma Soft Tissue Sarcomas · Sarcoma, Bone

Treatment Groups

This trial involves 2 different treatments. Proton Beam Radiation is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Proton Beam Radiation
RADIATION
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Proton Beam Radiation
2007
Completed Phase 2
~70

Side Effect Profile for Proton Beam Radiation/ Capecitabine Dose Level 1

Proton Beam Radiation/ Capecitabine Dose Level 1
Show all side effects
Fatigue
100%
Nausea
100%
Abdomen- pain
67%
Vomiting
67%
Anorexia
33%
Bilirubin
33%
Constipation
33%
Dehydration
33%
Hyperglycemia
0%
AST- SGOT
0%
Colitis
0%
Pain - Chest Wall
0%
Anxiety
0%
Back- pain
0%
Diarrhea w/o prior colostomy
0%
Dyspepsia
0%
Extremity-limb- pain
0%
Fever w/o neutropenia
0%
Weight loss
0%
ALT- SGPT
0%
This histogram enumerates side effects from a completed 2017 Phase 1 & 2 trial (NCT00438256) in the Proton Beam Radiation/ Capecitabine Dose Level 1 ARM group. Side effects include: Fatigue with 100%, Nausea with 100%, Abdomen- pain with 67%, Vomiting with 67%, Anorexia with 33%.

Eligibility

This trial is for patients born any sex aged 65 and younger. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Our radiation therapy team is able to time radiation treatments according to the concurrent chemotherapy protocol your oncologist prescribed. show original
Less than or equal to 30 years of age
Patients must be willing to receive follow-up care for a minimum of five years after treatment at MGH and annual visits unless it is too difficult to return to MGH for follow-up care. In that event, the patient or guardian must be willing to have their outside medical information released in order to track the results of treatment
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 5 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 5 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Proton Beam Radiation will improve 2 primary outcomes and 1 secondary outcome in patients with Sarcoma. Measurement will happen over the course of 5 years.

Dosimetric Comparison
5 YEARS
Comparison of Dose distribution to tumor and surrounding normal structures using DVH's generated from the proton plan used to treat the patient and the photon plan generated for comparison purposes.
Local Control
5 YEARS
Rates of local control using proton radiotherapy.
Acute and late toxicities
5 YEARS
Assess frequency and severity of morbidities from irradiation using proton beam therapy in this patient population.

Who is running the study

Principal Investigator
T. Y.
Torunn Yock, MD
Massachusetts General Hospital

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get sarcoma a year in the United States?

The incidence of sarcoma is extremely rare in developed countries. Sarcoma incidence in Japan has been declining since the 1990s, and the incidence has been increasing steadily among children, although in the US the number of reported cases of sarcoma continues to decrease (US Cancer 2006; 52: 1790-1796; 2008; 62: 1595-1596). There is no consensus to this, and several authors have attributed the decline to improved hygiene and sanitation. In fact, sarcoma has been observed to be decreasing in Japan, probably due to improved health and hygiene. However, the exact risk factors for developing sarcoma in Japan are unknown.

Anonymous Patient Answer

What causes sarcoma?

There is no single cause for sarcomas. The majority occur after a carcinogenesis event. It is thought that sarcomas may arise from multipotent mesenchymal stem cells. The genetic causes of sarcoma are poorly understood. There are many different ways in which a sarcoma may develop.\n

Anonymous Patient Answer

What is sarcoma?

Sarcoma may occur in any tissue of the body. However, it mainly occurs in adults at around the age of 50 and often spreads to other parts of the body. The two major histological types are soft-tissue sarcomas and bone sarcomas. Sarcomas may be diagnosed by biopsy of an area of tumours, the appearance of bone lesions, symptoms and sometimes the appearance of metastases, especially to the bones. The five-year survival rate in people with a high-grade soft-tissue sarcoma is 24%; one in twenty people with a low-grade sarcoma has it upgraded over the next three months. Sarcoma affects men and women equally.

Anonymous Patient Answer

Can sarcoma be cured?

Sarcoma has unpredictable and changing response to treatment, which makes cure impossible. However, in certain cases sarcomas can be controlled and cured with very good response to chemotherapy.

Anonymous Patient Answer

What are the signs of sarcoma?

The following are the signs and symptoms of sarcomas: fast-growing, persistent swelling in a limb, abnormal bleeding, and easy bruising. More than one symptom of sarcoma is common. Diagnostic imaging scans are also helpful when determining any tumours.\n

Anonymous Patient Answer

What are common treatments for sarcoma?

Most treatment for sarcoma revolves around chemotherapy, as there are no specific treatments that target sarcoma. Surgery is sometimes used to remove tumor in certain cases. There has been a significant amount of research concerning the benefits of hyperbaric oxygen therapy in the treatment of sarcoma.

Anonymous Patient Answer

Has proton beam radiation proven to be more effective than a placebo?

In a recent study, findings clearly demonstrated the efficacy and safety of a proton beam radiation therapy. The outcome of this group was better than that of patients treated with a placebo; therefore, if the results in human studies are corroborated, this type of radiation therapy can be considered for use in future clinical trials.

Anonymous Patient Answer

How serious can sarcoma be?

Sarcomas have the potential to invade or infiltrate surrounding soft tissue and, depending upon the site, to spread to distant sites. The most common sites of metastasis and their frequency from the top two sites with primary and metastatic tumors (i.e. lung, liver) are shown in the following table:\n\nThe incidence of solid tumors (including sarcoma) in the US has gone up since the 1970s. For example, in one study of over 100,000 cases of cancer among young adult males from 1975 to 1985, the incidence of sarcoma increased by more than 4-fold (from 2.1 cases per 100,000 males per year to 59.9 per 100,000).

Anonymous Patient Answer

Is proton beam radiation safe for people?

The dose from proton beam radiation compared well with standard external beam radiation for early stages of high-grade soft tissue sarcoma of the thigh or leg and is comparable with that of photon therapy in treating metastatic soft tissue sarcoma of all sites without any increased chances of severe toxicity. Proton beam radiation for early stages of soft tissue sarcoma may be considered as a potentially useful modality for patients and should be considered as a treatment option in the future clinical trials for metastatic disease.

Anonymous Patient Answer
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