Hypofractionated Radiotherapy Followed by Surgical Resection in the Treatment of Soft Tissue Sarcomas
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: Ultra-Hypo-fractionation Radiotherapy, Resection, Questionnaire Administration, Moderately-Hypo-fractionation Radiotherapy.
- Who it may be relevant to
- Registry conditions: Soft Tissue Sarcomas. 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
Prospective Observational Trial of Two Neoadjuvant Hypofractionated Radiotherapy Regimens Followed by Surgical Resection in the Treatment of Soft Tissue Sarcomas
Overview
The trial will use neoadjuvant hypofractionated radiotherapy followed by surgical resection in the treatment for soft tissue sarcoma. It will allow patients to be treated over a shorter course (5 or 15 days of radiation) compared to the traditional 5 week regimen. It is proposed that this will be possible without increasing the risk of wound complication or local recurrence compared with a traditional 5 week course of pre-operative radiation.
Detailed description
Study Objectives:
Primary:
* To investigate the efficacy of neoadjuvant hypo-fractionated radiotherapy (HRT) followed by surgical resection in the treatment of soft tissue sarcoma (STS) as measured by local control * Examine the side effect profile using Radiation Therapy Oncology Group (RTOG) and Common Terminology Criteria for Adverse Events (CTCAE) acute and late side effects criteria and major and minor post-operative complication rates.
OUTLINE: Patients are assigned to 1 of 2 groups by the radiation oncologist.
GROUP I (ULTRA-HYPOFRACTIONATION \[UH\]): Patients undergo HRT daily for a total of 5 fractions followed by surgery.
GROUP II (MODERATE HYPOFRACTIONATION \[MH\]): Patients undergo HRT daily for a total of 15 fractions followed by surgery.
After completion of study treatment, patients are followed up within 3 months, then every 3-6 months for a minimum of 2 years.
Interventions
- Radiation Ultra-Hypo-fractionation Radiotherapy
Five fractions of pre-operative radiation - Procedure Resection
Surgery - Other Questionnaire Administration
Ancillary studies - Radiation Moderately-Hypo-fractionation Radiotherapy
15 fractions of pre-operative radiation
Primary outcome measures
- Local control rate [Time frame: Approximately 2 years]
Secondary outcome measures (1)
- Complication rate [Time frame: Approximately 2 years]
Eligibility criteria
Inclusion criteria
- Histologic diagnosis of a soft tissue sarcoma of extremity, pelvis, chest wall or trunk/abdominal wall (non-retroperitoneal location)
- ECOG performance status 0-2
- Patient must be deemed able to comply with radiation treatment and surgery
Exclusion criteria
- History of prior radiation to the same area to be irradiated
- Pregnancy
- Active collagen vascular disease or patients genetically predisposed to increased radiation related side effects
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Vanderbilt-Ingram Cancer Center — Nashville
Identifiers
NCT: NCT04506008 · VICC SAR 2062