Neoadjuvant and Adjuvant Chemotherapy in High-risk Soft Tissue Sarcoma (NeoWTS)

Heidelberg University

Status and phase: Completed; Phase 2

Conditions: Soft Tissue Sarcoma

Treatments: Drug: EIA chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01382030

2004-002501-72 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

The role of chemotherapy in high-risk soft tissue sarcoma is controversial. Though many patients undergo initial curative resection, distant metastasis is a frequent event resulting in 5-year overall survival rates of only 50 - 60%. Neo-adjuvant and adjuvant chemotherapy has been applied to achieve pre-operative cytoreduction, assess chemosensitivity and to eliminate occult metastasis. The current protocol comprises for cycles of neoadjuvant chemotherapy ((EIA, etoposide 125 mg/m2 iv days 1 and 4, ifosfamide 1500 mg/m2 iv days 1 - 4, doxorubicin 50 mg/m2 day 1, pegfilgrastim 6 mg sc day 5), local surgery and radiotherapy as well as further 4 cycles of adjuvant EIA. Treatment response is assessed by MRI and CT scans and FDG-PET in a subgroup of patients.

Enrollment: 50 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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%

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Treatment Arm

Experimental group

Description:

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

Treatment:

Drug: EIA chemotherapy