Hypofractionated Radiation Therapy for Sarcoma
This study is evaluating whether a preoperative radiation therapy regimen is safe and effective for patients with soft tissue sarcomas.
See full descriptionAbout the trial for 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.
About The Treatment
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.
Approximate Timelines
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.
Who is running the study
Principal InvestigatorPatient Q & A Section
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.
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
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.
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.
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.
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.
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.
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.
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.