Neoadjuvant and Adjuvant Chemotherapy in High-risk Soft Tissue Sarcoma

NCT01382030 | Completed Phase 2 DMC

• 1 other identifier: 2004-002501-72
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Neo- and adjuvant chemotherapy is used in high-risk soft tissue sarcoma to improve systemic control. Patients in this trial are treated with 4 cycles of chemotherapy (EIA, etoposide, ifosfamide, adriamycin) preoperatively, followed by local surgery and radiotherapy. An additional 4 cycles of adjuvant chemotherapy is administered. Treatment response is assessed by MRI and CT scans and FDG-PET in a subgroup of patients.

Conditions

Soft Tissue Sarcoma

Keywords

Soft tissue sarcoma; High-risk; Neoadjuvant; Adjuvant; Chemotherapy; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

  Disease-free survival will be calculated from the time of definite surgery to radiologically proven local or distant failure or patient´s death due to sarcoma related cause.

  2 years after study completion

Secondary Outcomes (8)

• Overall Survival

  2 years after study completion

• Grade of histological necrosis

  After definite surgery, approx. 12-15 weeks after study inclusion

• Hematological toxicity

  Once weekly for an average of 8 months

• Renal Toxicity

  Once weekly for an average of 8 months

• Liver Toxicity

  Once weekly for an average of 8 months

Study Arms (1)

Treatment Arm

EXPERIMENTAL

All patients receive 4 cycles of EIA chemotherapy pre- and postoperatively. There is no further observation arm. The study is non-randomized.

Drug: EIA chemotherapy

Interventions

EIA chemotherapy DRUG

ifosfamide 1500 mg/m² iv days 1 - 4, etoposide 125 mg/m² iv days 1 and 4, and adriamycin 50 mg/m² iv day 1

Treatment Arm

Eligibility Criteria

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

You may qualify if:

• Soft tissue sarcoma histology
• Tumor size \>= 5 cm
• Deep/extracompartimental localization
• Grade 2/3 (FNCLCC)
• Patients with inadequate previous therapy
• Age 18-65 years
• normal bone marrow function
• normal liver function
• normal renal function
• Karnofsky index \>=80%

You may not qualify if:

• Chordoma
• Chondrosarcoma
• Kaposi´ sarcoma
• Neuroblastoma
• Mesothelioma
• Osteosarcoma/Ewings´sarcoma

Sponsors & Collaborators

• Heidelberg University: lead
• German Cancer Research Center: collaborator

Study Sites (1)

Heidelberg University Clinics

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Related Publications (2)

• Roeder F, Lehner B, Schmitt T, Kasper B, Egerer G, Sedlaczek O, Grullich C, Mechtersheimer G, Wuchter P, Hensley FW, Huber PE, Debus J, Bischof M. Excellent local control with IOERT and postoperative EBRT in high grade extremity sarcoma: results from a subgroup analysis of a prospective trial. BMC Cancer. 2014 May 20;14:350. doi: 10.1186/1471-2407-14-350.

  PMID: 24885755 DERIVED

• Schmitt T, Lehner B, Kasper B, Bischof M, Roeder F, Dietrich S, Dimitrakopoulou-Strauss A, Strauss LG, Mechtersheimer G, Wuchter P, Ho AD, Egerer G. A phase II study evaluating neo-/adjuvant EIA chemotherapy, surgical resection and radiotherapy in high-risk soft tissue sarcoma. BMC Cancer. 2011 Dec 7;11:510. doi: 10.1186/1471-2407-11-510.

  PMID: 22152120 DERIVED

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Gerlinde Egerer, MD

  Department of Hematology, Heidelberg University Clinics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 17, 2011
• First Posted: June 27, 2011
• Study Start: June 1, 2005
• Primary Completion: September 1, 2010
• Study Completion: January 1, 2011
• Last Updated: June 27, 2011

Record last verified: 2011-06

Locations

DE (1)