Hypofractionated Radiation Therapy for Sarcoma

1
Effectiveness
2
Safety
M D Anderson Cancer Center, Houston, TX
Sarcoma+8 More
Hypofractionated Radiation Therapy - Radiation
Eligibility
18+
All Sexes
Eligible conditions
Sarcoma

Study Summary

This study is evaluating whether a shorter course of radiation therapy may be more effective than a longer course of radiation therapy for individuals with soft tissue sarcoma.

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Eligible Conditions

  • Sarcoma
  • Stage IIIA Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
  • Stage IA Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
  • Resectable Soft Tissue Sarcoma
  • Stage IB Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
  • Stage IIIB Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
  • Stage II Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
  • Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
  • Stage I Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Hypofractionated Radiation Therapy will improve 1 primary outcome and 9 secondary outcomes in patients with Sarcoma. Measurement will happen over the course of Up to 10 years after radiation therapy.

Year 10
Disease free survival (DFS) time
Disease specific survival time
Functional outcomes
Local recurrence free survival
Pattern of local relapse (in radiation field, margin of field, out of radiation field)
Quality of life
Time to relapse
Day 120
Incidence of acute toxicity other than MWC
Incidence of late onset toxicity
Day 120
Time to a major wound complication (MWC)

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Control
Treatment (hypofractionated RT)

This trial requires 120 total participants across 2 different 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 in Phase 2 and have already been tested with other people.

Treatment (hypofractionated RT)Patients receive hypofractionated radiation therapy in 15 daily fractions over 3 weeks in the absence of disease progression or unacceptable toxicity.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hypofractionated Radiation Therapy
2016
Completed Phase 2
~20

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 120 days after radiation therapy
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 120 days after radiation therapy for reporting.

Closest Location

M D Anderson Cancer Center - Houston, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Sarcoma or one of the other 8 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Tumor located in the soft tissues of the extremities or superficial trunk
Deemed a candidate for complete macroscopic resection of the primary sarcoma
Histologically confirmed sarcoma arising in soft tissue
Patient may have had excisional biopsy of all gross disease at an outside facility with positive or uncertain resection margins and still be eligible if the evaluating sarcoma surgeon in the participating institution recommends oncologic re-resection of the surgical bed to obtain negative margins after a course of neoadjuvant irradiation (a sandwich approach of marginal excision-->radiation therapy(RT)--> wide excision, as per our standard practice)
No evidence of nodal or distant metastases as determined by clinical examination or any form of imaging
Has provided written informed consent for participation in this trial
Eastern Cooperative Oncology Group (ECOG) performance status of 3 or less
Life expectancy greater than 6 months
Patients capable of childbearing are using adequate contraception
Available for follow-up

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?

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Sarcoma and cancers in other tissues can be related because they are often of the same type of cell. Some of these cancers may be related by a common origin. In addition to viral infection and environmental triggers, genetics can influence whether an individual develops cancer, and there is one type that affects the likelihood of developing sarcoma, as in people with Von Hippel-Lindau disease.

Unverified Answer

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

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Approximately 80,000 people in the United States will be diagnosed with sarcoma each year. Older men are at highest risk for sarcoma, but the gender gap is narrowing in recent years.

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What are common treatments for sarcoma?

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In the United States, radiotherapy remains the treatment of choice in sarcoma and is most commonly used in combination with chemotherapy. Radiation therapy is also recommended for sarcomas from other locations such as brain and soft tissue with metastases. In pediatric patients, chemotherapy alone may be preferable. Chemotherapy and surgery continue to be standard of care in sarcoma.

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What are the signs of sarcoma?

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Signs of sarcoma include fast heartbeat (tachycardia), fast, shallow breathing (bradypnea), shortness of breath (dyspnea), swelling in the limbs (ly edema), loss of appetite and weight loss (proportional to the tumour). Weakness in the legs in combination with loss of appetite (weight loss), skin changes, fever, loss of urination may also indicate the presence of a tumour.

Unverified Answer

What is sarcoma?

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The sarcoma is a cancer that forms in multiple types of soft tissues. Most sarcoms are cancer of the muscle layers, while others form in other organs or in connective tissues.\n

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Can sarcoma be cured?

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Treatment of sarcoma is likely ineffective but may confer a survival advantage for patients lacking clinical evidence of cancer, particularly when combined with chemotherapy. Therefore, the prognosis of advanced or metastatic sarcoma depends largely on treatments available at diagnosis.

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What is the survival rate for sarcoma?

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Sarcoma survivors who live longer than three years after diagnosis of sarcoma report no sign of disease, as compared to those with NED who live to less that 2 years. NED is the hallmark of sarcomas and is a symptom of poor prognosis not the actual outcome. In fact, the very existence of these patients is often disputed by the health care professionals as there is no way to prove the illness as real or a symptom of sarcoma. However with NED patients, who have survived for three years or more, then there is not yet any proof against the presence and existence of sarcomas.

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How quickly does sarcoma spread?

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It is the key that cancer of any type, including sarcoma, will rarely spread firstly to local tissues (localised), and then, secondly, to other organs in the body. The reason for the small percentage of sarcoma cancers which have metastasised to distant organ sites is a combination of: (1) the nature and location of the primary tumor, which dictates the likelihood of metastatic dissemination with the sarcoma cell type (2) the size (size being in reference to the average number of cells present in the primary tumor multiplied by the proportion that is malignant cells - e.g.

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Have there been any new discoveries for treating sarcoma?

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Given that sarcoma remains a deadly disease as reported in The New England Journal of Medicine in 2013, it is inevitable for there to be new insights into the cause, pathogenesis, etiology, etc. of sarcoma. More research is needed to better understand the pathogenesis of sarcoma not only to help in preventing the onset, but also to offer options for prevention and treatment that are not available today. With the incidence of [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) estimated at 1.1 million cases per year in the USA, it becomes readily understandable that there will certainly be new research and development efforts for both the prevention and treatments for both cancer and sarcoma.

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What are the chances of developing sarcoma?

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For patients who have previously been diagnosed with or treated for cancer, the risk of developing a primary soft tissue sarcoma (STS) seems to be approximately the same irrespective of the cancer type and the treatment used. For cancer survivors who have not had any prior cancer diagnosis, the approximate risk of developing a first STS over 20 years is 15%. While these figures are only an approximation, we think that these considerations are useful for patients who are asked about their cancer/cancer treatment history.

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