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Trial of Neoadjuvant Intensity-Modulated Radiation Therapy Followed by Surgery and Intraoperative Radiation Therapy in Resectable Retroperitoneal Soft Tissue Sarcoma (RETRO-WTS)

NCT01566123 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2020-04-03

No results posted yet for this study

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.

Conditions

  • Retroperitoneal Soft Tissue Sarcoma

Interventions

RADIATION

Neoadjuvant intensity-modulated radiation therapy (IMRT)

neoadjuvant intensity-modulated radiation therapy, single dose 2.0-2.4 Gy, total dose 50-56 Gy

RADIATION

intraoperative radiation therapy (IORT)

during surgery, 10-12 Gy (90% isodose) to the tumor bed or residual disease

Sponsors & Collaborators

  • German Cancer Research Center

    collaborator OTHER

  • University Hospital Heidelberg

    lead OTHER

Principal Investigators

  • Juergen Debus, M.D., Ph.D. · University Hospital Heidelberg

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2020-01-31
Completion
2020-02-29

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01566123 on ClinicalTrials.gov