Clinical trial NCT01382030: Neoadjuvant and Adjuvant Chemotherapy in High-risk Soft Tissue Sarcoma
Official title: A Phase II Study Evaluating Neo-/Adjuvant EIA Chemotherapy, Surgical Resection and Radiotherapy in High-risk Soft Tissue Sarcoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Soft Tissue Sarcoma
Keywords: Soft tissue sarcoma
High-risk
Neoadjuvant
Adjuvant
Chemotherapy
Radiotherapy
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: German Cancer Research Center
First posted: 2011-06-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Disease-free survival
timeFrame: 2 years after study completion
Secondary outcomes:
measure: Overall Survival
timeFrame: 2 years after study completion
measure: Grade of histological necrosis
timeFrame: After definite surgery, approx. 12-15 weeks after study inclusion
measure: Hematological toxicity
timeFrame: Once weekly for an average of 8 months
measure: Renal Toxicity
timeFrame: Once weekly for an average of 8 months
measure: Liver Toxicity
timeFrame: Once weekly for an average of 8 months
measure: Correlation of Tumor Necrosis and Decline in PET SUV
timeFrame: After tumor resection, approx. 12-15 weeks after study inclusion
measure: Cardiac Toxicity
timeFrame: Every 6 weeks for an average of 8 months
measure: Radiologic Tumor Response
timeFrame: Every 6 weeks for an average of 8 months, then every 3 months for 2 years
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Heidelberg University Clinics
state: Baden-Wuerttemberg
Study officials:
affiliation: Department of Hematology, Heidelberg University Clinics
name: Gerlinde Egerer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.