Prospective Observational Trial of Two Neoadjuvant Hypofractionated Radiotherapy Regimens Followed by Surgical Resection in the Treatment of Soft Tissue Sarcomas

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.

Arms & 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

Outcome measures

Eligibility criteria