Spots Global Cancer Trial Database for Hypofractionated Radiotherapy Followed by Surgical Resection in the Treatment of Soft Tissue Sarcomas

Study Description

Brief Summary: 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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