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

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ClinicalTrials.gov Identifier: NCT01552239
Recruitment Status : Recruiting
First Posted : March 13, 2012
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Technische Universität München

Brief 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.


Condition or disease Intervention/treatment Phase
Soft Tissue Sarcoma of the Limb AJCC Stage II and III Radiation: IMRT/IGRT, Tumor resection, Brachytherapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Preoperative Radiotherapy for Sarcomas of the Extremities With Intensity-Modulation, Image-Guidance, Small Safety-margins and Brachytherapy Conditioned by Resection Margin
Study Start Date : August 2011
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1 Arm

Stratum A:

R0, primary wound closure

Stratum B:

R0, secondary wound closure

Stratum C:

R1, tertiary wound closure

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





Primary Outcome Measures :
  1. Wound Complication Rate [ Time Frame: 3 months ]
    Wound Complication Rate up to 3 months after tumor resection


Secondary Outcome Measures :
  1. Efficacy [ Time Frame: 2 years ]

    Efficacy:

    Rate of margin-free resection Local control rate (LC) Metastasis-Free Survival (MFS) Disease-Free Survival (DFS) Disease-Specific Survival, Overall Survival (OS) Limb Preservation Rate (LP)


  2. Safety [ Time Frame: 2 years ]
    Acute toxicity as measured by CTCAE v. 4.03 Late toxicity (skin, soft tissue, joint, bone, neural toxicity) as measured by CTCAE v. 4.03

  3. Limb Functionality [ Time Frame: 2 years ]
    as measured by the Musculoskeletal Tumor Society (MSTS) rating scale and the Toronto Extremity Salvage Score (TESS)

  4. Quality of Life [ Time Frame: 2 years ]
    as measured by QLQ C30

  5. Translational [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Histologic and radiographic proof of localized high-risk soft tissue sarcoma meeting the following criteria:

  • Lesion originates in extremity

    • upper extremity lesions may occur from the medial border of the scapula to tumors as far distal as the finger tips
    • lower extremity regions include hip girdle tumors commencing at the iliac crest, excluding lesions arising from within the pelvis, and extends to include lesions as far distal as the toes
  • AJCC Stage II or III disease (except T1a-tumors or N1)
  • Primary presentation or local recurrence
  • after biopsy or inadequate surgery resulting in residual tumor in cross-sectional imaging
  • Tumors must be considered resectable according to cross sectional imaging, or potentially resectable after preoperative radiotherapy
  • ECOG Performance Status 0-2
  • Informed Consent

Exclusion Criteria:

  • Diagnosis of the following:

    • Primitive neuroectodermal tumor
    • Soft tissue Ewing`s sarcoma
    • Extraskeletal osteo- or chondrosarcoma
    • Aggressive fibromatosis (desmoid tumors)
    • Dermatofibrosarcoma protuberans
  • Regional nodal disease or unequivocal distant metastasis
  • Life expectancy < 1 year
  • Pregnancy
  • Major medical illness that would preclude study treatment
  • History of major wound complication or recurrent skin infection
  • Known HIV positivity
  • < 2 weeks elapsed from prior surgery or cytotoxic chemotherapy
  • persisting acute toxicities > grade 1 in tumor-bearing limb resulting from prior treatment with anti-cancer modalities
  • Cytotoxic chemotherapy, targeted therapy or investigational agents concurrent to study treatment
  • Prior radiotherapy to the site of present STS.
  • Chronic requirement for treatment with immuno¬suppressive agents or steroids.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01552239


Contacts
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Contact: Barbara Röper, MD +49-89-4140 ext 4509 barbara.roeper@lrz.tu-muenchen.de

Locations
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Germany
Klinikum rechts der Isar Recruiting
Munich, Germany, 81675
Contact: Barbara Röper, MD    49-89-4140 ext 4502    barbara.roeper@lrz.tu-muenchen.de   
Sub-Investigator: Michael Molls, MD         
Sponsors and Collaborators
Technische Universität München
Investigators
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Principal Investigator: Barbara Röper, MD Klinik für Strahlentherapie und Radiologische Onkologie

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT01552239     History of Changes
Other Study ID Numbers: PRE-1205-ROE-0050-I
No. 2009.906.1 ( Other Grant/Funding Number: Wilhelm-Sander-Stiftung )
First Posted: March 13, 2012    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018

Keywords provided by Technische Universität München:
Soft tissue sarcoma
Intensity-Modulated Radiation Therapy (IMRT)
Tomotherapy
Safety Margins
Image-guided Radiation Therapy
Brachytherapy
interstitial

Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms