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

NCT ID: NCT01552239

Last Updated: 2018-10-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2019-10-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1 Arm

Stratum A:

R0, primary wound closure

Stratum B:

R0, secondary wound closure

Stratum C:

R1, tertiary wound closure

Group Type: EXPERIMENTAL

IMRT/IGRT, Tumor resection, Brachytherapy

Intervention Type: 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

Interventions

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

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Technical University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barbara Röper, MD

Role: PRINCIPAL_INVESTIGATOR

Klinik für Strahlentherapie und Radiologische Onkologie

Locations

Klinikum rechts der Isar

Munich, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Barbara Röper, MD

Role: CONTACT

barbara.roeper@lrz.tu-muenchen.de

+49-89-4140 ext. 4509

Facility Contacts

Barbara Röper, MD

Role: primary

barbara.roeper@lrz.tu-muenchen.de

49-89-4140 ext. 4502

References

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.

Reference Type: DERIVED

PMID: 26573139 (View on PubMed)

Other Identifiers

No. 2009.906.1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PRE-1205-ROE-0050-I

Identifier Type: -

Identifier Source: org_study_id