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

Primary Purpose

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

Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
IMRT/IGRT, Tumor resection, Brachytherapy
Sponsored by
Technical University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Soft Tissue Sarcoma of the Limb focused on measuring Soft tissue sarcoma, Intensity-Modulated Radiation Therapy (IMRT), Tomotherapy, Safety Margins, Image-guided Radiation Therapy, Brachytherapy, interstitial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Klinikum rechts der IsarRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1 Arm

Arm Description

Stratum A: R0, primary wound closure Stratum B: R0, secondary wound closure Stratum C: R1, tertiary wound closure

Outcomes

Primary Outcome Measures

Wound Complication Rate
Wound Complication Rate up to 3 months after tumor resection

Secondary Outcome Measures

Efficacy
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)
Safety
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
Limb Functionality
as measured by the Musculoskeletal Tumor Society (MSTS) rating scale and the Toronto Extremity Salvage Score (TESS)
Quality of Life
as measured by QLQ C30
Translational

Full Information

First Posted
July 26, 2011
Last Updated
October 15, 2018
Sponsor
Technical University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT01552239
Brief Title
Preoperative Radiotherapy for Sarcomas of the Extremities With Intensity-Modulation, Image-Guidance and Small Safety-margins
Acronym
PREMISS
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 Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
October 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technical University of Munich

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft Tissue Sarcoma of the Limb, AJCC Stage II and III
Keywords
Soft tissue sarcoma, Intensity-Modulated Radiation Therapy (IMRT), Tomotherapy, Safety Margins, Image-guided Radiation Therapy, Brachytherapy, interstitial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1 Arm
Arm Type
Experimental
Arm Description
Stratum A: R0, primary wound closure Stratum B: R0, secondary wound closure Stratum C: R1, tertiary wound closure
Intervention Type
Radiation
Intervention Name(s)
IMRT/IGRT, Tumor resection, Brachytherapy
Intervention Description
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 Measure Information:
Title
Wound Complication Rate
Description
Wound Complication Rate up to 3 months after tumor resection
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Efficacy
Description
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)
Time Frame
2 years
Title
Safety
Description
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
Time Frame
2 years
Title
Limb Functionality
Description
as measured by the Musculoskeletal Tumor Society (MSTS) rating scale and the Toronto Extremity Salvage Score (TESS)
Time Frame
2 years
Title
Quality of Life
Description
as measured by QLQ C30
Time Frame
2 years
Title
Translational
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barbara Röper, MD
Phone
+49-89-4140
Ext
4509
Email
barbara.roeper@lrz.tu-muenchen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Röper, MD
Organizational Affiliation
Klinik für Strahlentherapie und Radiologische Onkologie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinikum rechts der Isar
City
Munich
ZIP/Postal Code
81675
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Röper, MD
Phone
49-89-4140
Ext
4502
Email
barbara.roeper@lrz.tu-muenchen.de
First Name & Middle Initial & Last Name & Degree
Michael Molls, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
26573139
Citation
Roper B, Heinrich C, Kehl V, Rechl H, Specht K, Wortler K, Topfer A, Molls M, Kampfer S, von Eisenharth-Rothe R, Combs SE. Study of Preoperative Radiotherapy for Sarcomas of the Extremities with Intensity-Modulation, Image-Guidance and Small Safety-margins (PREMISS). BMC Cancer. 2015 Nov 16;15:904. doi: 10.1186/s12885-015-1633-y.
Results Reference
derived

Learn more about this trial

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

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