Trial of Neoadjuvant Intensity-Modulated Radiation Therapy Followed by Surgery and Intraoperative Radiation Therapy in Resectable Retroperitoneal Soft Tissue Sarcoma (RETRO-WTS)
- Conditions
- Retroperitoneal Soft Tissue Sarcoma
- Interventions
- Radiation: Neoadjuvant intensity-modulated radiation therapy (IMRT)Radiation: intraoperative radiation therapy (IORT)
- Registration Number
- NCT01566123
- Lead Sponsor
- University Hospital Heidelberg
- Brief Summary
Local control rates in patients with retroperitoneal soft tissue sarcoma (RSTS) remain disappointing even after gross total resection, mainly because wide margins are not achievable in the majority of patients. In contrast to extremity sarcoma, postoperative radiation therapy (RT) has shown limited efficacy due to its limitations in achievable dose and coverage. Although Intraoperative Radiation Therapy (IORT) has been introduced in some centers to overcome these dose limitations and resulted in improved outcome, local failure rates are still high even if considerable treatment related toxicity is accepted. As postoperative administration of RT has some general disadvantages, neoadjuvant approaches could offer benefits in terms of dose escalation, target coverage and reduction of toxicity, especially if highly conformal techniques like intensity-modulated radiation therapy (IMRT) are considered.
Therefore the RETROWTS trials has been designed as a prospective, one armed, single center phase I/II study investigating a combination of neoadjuvant dose-escalated IMRT (50-56 Gy) followed by surgery and IORT (10-12 Gy) in patients with at least marginally resectable RSTS. The primary objective is the local control rate after five years. Secondary endpoints are progression-free and overall survival, acute and late toxicity, surgical resectability and patterns of failure. The aim of accrual is 37 patients in the per-protocol population.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
- written informed consent
- histologically confirmed, primary or locally recurrent soft tissue sarcoma of the retroperitoneal space
- judged as at least marginally resectable
- absence of distant metastases
- tumor size ≥ 5 cm
- missing written informed consent
- missing histological confirmation of soft tissue sarcoma
- Desmoid tumor (syn. aggressive fibromatosis)
- judged as gross incomplete or not resectable
- incomplete staging
- presence of distant metastases
- prior radiation therapy to the abdominal region
- participation in another clinical interventional study
- inflammatory bowel disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description A Neoadjuvant intensity-modulated radiation therapy (IMRT) Neoadjuvant Intensity-Modulated Radiation Therapy Followed by Surgery and Intraoperative Radiation Therapy in Resectable Retroperitoneal Soft Tissue Sarcoma A intraoperative radiation therapy (IORT) Neoadjuvant Intensity-Modulated Radiation Therapy Followed by Surgery and Intraoperative Radiation Therapy in Resectable Retroperitoneal Soft Tissue Sarcoma
- Primary Outcome Measures
Name Time Method Local Control Rate 5 year
- Secondary Outcome Measures
Name Time Method Overall Survival up to five years from first day of treatment Progression free survival up to 5 years from first day of treatment Late Toxicity up to 5 years after first day of treatment scored according to CTCAE 3.0 and RTOG criteria
Severe acute gastrointestinal toxicity up to 3 months from first day of treatment severe defined as grade \>= III, scored according to CTC AE 3.0
Acute toxicity up to 3 months from first day of treatment scored according to CTCAE 3.0
Trial Locations
- Locations (1)
University Hospital Heidelberg
🇩🇪Heidelberg, Baden-Württemberg, Germany