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

NCT01552239 | Unknown Phase 2

• 2 other identifiers: PRE-1205-ROE-0050-INo. 2009.906.1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Wound Complication Rate

  Wound Complication Rate up to 3 months after tumor resection

  3 months

Secondary Outcomes (5)

• Efficacy

  2 years

• Safety

  2 years

• Limb Functionality

  2 years

• Quality of Life

  2 years

• Translational

  2 years

Study Arms (1)

1 Arm

EXPERIMENTAL

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

Radiation: IMRT/IGRT, Tumor resection, Brachytherapy

Interventions

IMRT/IGRT, Tumor resection, Brachytherapy RADIATION

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

1 Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

Klinikum rechts der Isar

Munich, 81675, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 26573139 DERIVED

MeSH Terms

Conditions

Sarcoma

Interventions

Brachytherapy

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Study Officials

• Barbara Röper, MD

  Klinik für Strahlentherapie und Radiologische Onkologie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbara Röper, MD

CONTACT

+49-89-4140; barbara.roeper@lrz.tu-muenchen.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2011
• First Posted: March 13, 2012
• Study Start: August 1, 2011
• Primary Completion: June 1, 2019
• Study Completion: October 1, 2019
• Last Updated: October 16, 2018

Record last verified: 2018-10

Locations

DE (1)