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Preoperative Radiotherapy for Sarcomas of the Extremities With Intensity-Modulation, Image-Guidance and Small Safety-margins

NCT01552239 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-10-16

No results posted yet for this study

Summary

RATIONALE: Modern radiotherapy techniques in a neoadjuvant setting have the potential to minimize morbidity and maximize efficacy. An additional boost dose can be provided locally by HDR-brachytherapy in patients with positive margins after tumor resection.

PURPOSE: This phase II trial is studying the safety and efficacy of a combination of modern radiotherapy elements applied to the tumor and small volumes of surrounding normal tissue (IMRT, IGRT; brachytherapy in case of positive resection margin) and see how well it works in treating patients with High-Risk Soft Tissue Sarcoma of the Extremities.

Conditions

  • Soft Tissue Sarcoma of the Limb
  • AJCC Stage II and III

Interventions

RADIATION

IMRT/IGRT, Tumor resection, Brachytherapy

All: Preoperative IMRT with small safety margins (GTV according to MRT plus 1.5cm laterally / 3cm proximodistally) to 50Gy total dose, 2 Gy single dose, 5 fractions per week, daily IGRT with in-room CT (Tomotherapy) Tumor resection after 4-6 weeks Stratum C: Interstitial Brachytherapy to tumor bed with 15 Gy total dose, 3 Gy single dose b.i.d. in second week after tumor resection

Sponsors & Collaborators

  • Technical University of Munich

    lead OTHER

Principal Investigators

  • Barbara Röper, MD · Klinik für Strahlentherapie und Radiologische Onkologie

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2019-06-30
Completion
2019-10-31

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 NCT01552239 on ClinicalTrials.gov