Preoperative 5-Day Radiotherapy for Soft Tissue Sarcoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hypofractionated Radiation Therapy.
- Who it may be relevant to
- Registry conditions: Soft Tissue Sarcoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Preoperative 5-Day Radiotherapy for Soft Tissue Sarcoma: A Single Institution Phase II Trial
Overview
The purpose of this research study is to preserve healthy tissue around the cancer on the arm(s) and/or leg(s) using Hypofractionated radiotherapy, while treating the cancer and preventing it from spreading to other areas of the body.
Detailed description
This study is for subjects that have been diagnosed with cancer in their arm, leg, or trunk (the part of the body that involves the chest, abdomen, and pelvis). The purpose of this research study is to preserve healthy tissue around the cancer on the arm(s) and/or leg(s) using Hypofractionated radiotherapy, while treating the cancer and preventing it from spreading to other areas of the body. This study will look at early side effects and effectiveness of preoperative 5-day Hypofractionated radiotherapy. Active participation in the study will take about 12 visits and are completed once the participant has a 6-month post-operation visit.
Interventions
- Radiation Hypofractionated Radiation Therapy
Participants will receive preoperative 5-day HFRT (30Gy/5fx once daily over consecutive weekdays) followed by "standard of care" wide local excision 2-6 weeks later.
Primary outcome measures
- HFRT Safety [Time frame: 6 months]
Secondary outcome measures (2)
- Treatment Response [Time frame: 6 months]
- Safety Profile [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- Willingness and provision of informed consent via signed and dated copy.
- Histologically confirmed STS of extremity or trunk.
- Male or female, aged greater than or equal to 18 years old
- ECOG performance status 0-3
- Meets screening criteria for receipt of radiotherapy.
- Deemed eligible for wide local excision.
- Patient and/or physician identified possible barriers to receiving a 5-week course of conventionally fractionated preoperative radiotherapy. Potential barriers include but are not limited to concern for local progression that could precluded or complicate limb sparing surgery, concern for distant progression that could result in patient being non-operative, financial and/or physical burden of travel for daily treatments, financial burden of time away from work or caregiving.
Exclusion criteria
- Distant metastatic disease
- Prior radiation therapy in the proposed treatment area
- Simultaneous treatment of another malignancy
- Women who are pregnant or plan to become pregnant during the period of radiation therapy
- Planned concurrent administration of chemotherapy and radiation therapy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Medical University of South Carolina — Charleston
Identifiers
NCT: NCT06905132 · 104131 · Pro00141818