Prospective Observational Trial of Two Neoadjuvant Hypofractionated Radiotherapy Regimens Followed by Surgical Resection in the Treatment of Soft Tissue Sarcomas
Vanderbilt-Ingram Cancer Center
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- RadiationUltra-Hypo-fractionation Radiotherapy
Five fractions of pre-operative radiation
- ProcedureResection
Surgery
- OtherQuestionnaire Administration
Ancillary studies
- RadiationModerately-Hypo-fractionation Radiotherapy
15 fractions of pre-operative radiation
Location
- Vanderbilt-Ingram Cancer CenterNashville, Tennessee