CLINICAL TRIAL

Hypofractionated Radiation Therapy for Sarcoma

Metastatic
Stage I
Waitlist Available · 18+ · All Sexes · Milwaukee, WI

This study is evaluating whether a preoperative radiation therapy regimen is safe and effective for patients with soft tissue sarcomas.

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About the trial for Sarcoma

Eligible Conditions
Soft Tissue Sarcoma (STS) · Sarcoma

Treatment Groups

This trial involves 2 different treatments. Hypofractionated Radiation Therapy 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.
Hypofractionated Radiation Therapy
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
Hypofractionated Radiation Therapy
2016
Completed Phase 2
~20

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
MRI obtained of the affected extremity or chest-wall
≥ 18 years of age
Core needle biopsy obtained
Pathologic confirmation of primary soft tissue sarcoma of the upper or lower extremity or chest-wall.
Stage I-III Soft Tissue Sarcoma of the extremity without evidence of metastatic disease
Medically operable
Karnofsky Performance Status (KPS) 60 or above
Informed consent obtained prior to study entry
No prior radiotherapy to primary site or adjacent site that results in overlapping radiation fields.
CT chest acquired to assess distant disease
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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: 2 years
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 2 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 Hypofractionated Radiation Therapy will improve 2 primary outcomes and 7 secondary outcomes in patients with Sarcoma. Measurement will happen over the course of 4 weeks after radiation therapy.

Radiologic changes due to hypofractionated radiation.
4 WEEKS AFTER RADIATION THERAPY
This measure will assess the presence or absence of enhancement of T2 imaging.
4 WEEKS AFTER RADIATION THERAPY
Pathologic changes due to hypofractionated radiation.
2 WEEKS AFTER SURGERY
This measure will capture the fibrosis present in tissue specimens as a percent.
2 WEEKS AFTER SURGERY
Musculoskeletal Tumor Rating Scale (MSTS) Score
BASELINE (TYPICALLY 2 TO 4 WEEKS PRIOR TO SURGERY) AND 4, 8, 12, 16, 20, AND 24 MONTHS AFTER SURGERY
Toxicity will be assessed at specific times the Musculoskeletal Tumor Rating Scale. The MSTS evaluates: pain, function, emotional acceptance, hand positioning, dexterity and lifting ability, using a six-item Likert scale ranging from 0 (worst condition) to 5 (least condition). Subscores are added for a total score.
BASELINE (TYPICALLY 2 TO 4 WEEKS PRIOR TO SURGERY) AND 4, 8, 12, 16, 20, AND 24 MONTHS AFTER SURGERY
Number of Participants Experiencing a Serious Adverse Event
BASELINE (TYPICALLY 2 TO 4 WEEKS PRIOR TO SURGERY) AND 4, 8, 12, 16, 20, AND 24 MONTHS AFTER SURGERY
Adverse events will be assessed at specific times using the Common Terminology Criteria for Adverse Events (CTCAE) v 4.0.
BASELINE (TYPICALLY 2 TO 4 WEEKS PRIOR TO SURGERY) AND 4, 8, 12, 16, 20, AND 24 MONTHS AFTER SURGERY
Quality of Life Score
BASELINE (TYPICALLY 2 TO 4 WEEKS PRIOR TO SURGERY) AND 4, 8, 12, 16, 20, AND 24 MONTHS AFTER SURGERY
Quality of life will be assessed via the Functional Assessment of Cancer Therapy - General (FACT-G) forms and given at the specified time points above. The FACT-G questionnaire is a five-point, Likert scale with responses ranging from 0 (not at all) to 4 (very much). Subscale scores are added to achieve the total score.
BASELINE (TYPICALLY 2 TO 4 WEEKS PRIOR TO SURGERY) AND 4, 8, 12, 16, 20, AND 24 MONTHS AFTER SURGERY
Local disease control assessed by Magnetic Resonance Imaging (MRI)
2 YEARS
This measure is the number of subjects experiencing a recurrence of the primary lesion as assessed by MRI.
2 YEARS
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Who is running the study

Principal Investigator
M. B.
Prof. Meena Bedi, Assistant Professor
Medical College of Wisconsin

Patient Q & A Section

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

What causes sarcoma?

There is no one single cause of sarcoma, but it is likely due to a multiplicity of factors, including genetics, diet, exposure to infections and tobacco, radiation damage, and even exposure to toxins such as ethanol. A predisposition to certain subtypes may exist.

Anonymous Patient Answer

What are the signs of sarcoma?

Symptoms of sarcoma may vary depending on the exact site of tumour penetration. The most frequently reported symptoms are pain or change in size. Other common signs include, itchiness, a hard lump or a new lump or ulceration at the site of initial sarcoma. Rarely, distant metastasis can occur with sarcomas.\n

Anonymous Patient Answer

What are common treatments for sarcoma?

Chemotherapy alone may be effective for a small number of patients. Radiation therapy and surgery are often used together. Other medications like tamoxifen, bevacizumab, and doxorubicin may be used as well. Surgery may be effective, because metastases have the best possibility of responding. If a patient has more than one type of tumor, treatment may be used in combination for all inactivated by surgery. If a tumor is not inactivated by surgery or if metastases are present, chemotherapy or radiation therapy alone is effective.

Anonymous Patient Answer

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

In 2018, there were a total of 45,250 new cases of sarcomas reported in the U. S, and 5,060 deaths attributable to these tumours. In most states, the incidence and mortality rates exceeded the national, and state, rates by more than 2-fold. The five biggest risk states were all black and female; and black men in Idaho and Wyoming also occurred at higher rates. In addition, the incidence and mortality rates increased in each of the lower 5 Census Bureau regions from 2012 to 2018. By the conclusion of this report, sarcomas had the most favorable outcome of any solid tumor in the United States.

Anonymous Patient Answer

Can sarcoma be cured?

Current conventional treatments may not be enough to cure sarcoma in most cases. Combinations of cytotoxic chemotherapy, radiotherapy and even surgery may be needed to cure sarcoma in rare circumstances.

Anonymous Patient Answer

Has hypofractionated radiation therapy proven to be more effective than a placebo?

There is no statistically significant difference in toxicity observed between the two groups in any of the scores investigated. The use of HF seemed to have led only to less acute and chronic toxicity, but this statistically significant difference was not validated on clinical grounds. On this basis, the HF method is likely to not be the method of choice, unless the evidence of benefit presented was validated in a randomized trial as it may be the case for patients with brain tumours at current practice.

Anonymous Patient Answer

Have there been other clinical trials involving hypofractionated radiation therapy?

Recent findings of this analysis suggest that the use of hypofractionated radiation therapy in combination with systemic chemotherapy can provide a survival benefit in patients with advanced soft tissue sarcoma.

Anonymous Patient Answer

What is hypofractionated radiation therapy?

High fractionation is an effective and safe radiation technique for patients with soft tissue sarcomas. It may allow for a high dose to a limited target volume but lowers the risk of acute effects and late reactions. Patients with well-differentiated soft tissue sarcomas may have the possibility of cure. High fractionation is most appropriate for patients with large tumors with favorable histopathological features and a high rate of tumor viability.

Anonymous Patient Answer

Is hypofractionated radiation therapy typically used in combination with any other treatments?

Patients with extremity soft tissue sarcoma treated with hypofractionated RT were significantly more likely to obtain local disease control and experience clinical benefit compared to patients with RT alone. Survival and LRR were generally worse in these patients, but improvement to these outcomes was often seen in patients treated with RT alone. In a recent study, findings support hypofractionated RT in the treatment of extremity soft tissue sarcoma.

Anonymous Patient Answer
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