Neoadjuvant and Adjuvant Chemotherapy in High-risk Soft Tissue Sarcoma

Soft Tissue Sarcoma Clinical Trial

— NeoWTS  

Official title:

A Phase II Study Evaluating Neo-/Adjuvant EIA Chemotherapy, Surgical Resection and Radiotherapy in High-risk Soft Tissue Sarcoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01382030
• Other study ID #: 2004-002501-72
• Secondary ID: 2004-002501-72
• Status: Completed
• Phase: Phase 2
• First received: June 17, 2011
• Last updated: June 23, 2011
• Start date: June 2005
• Est. completion date: January 2011

Study information

• Verified date: June 2011
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sarcoma
• Soft Tissue Sarcoma

Intervention

Drug:
• EIA chemotherapy
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

Locations

Country	Name	City	State
Germany	Heidelberg University Clinics	Heidelberg	Baden-Wuerttemberg

Sponsors (2)

Lead Sponsor	Collaborator
Heidelberg University	German Cancer Research Center

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Overall Survival	Overall survival will be calculated as the time interval from the date of therapy induction to patient's death or last follow up.	2 years after study completion	No
Secondary	Grade of histological necrosis	Grade of histological necrosis in tumor specimen will be assessed after surgery and graded according to Salzer-Kuntschik.	After definite surgery, approx. 12-15 weeks after study inclusion	No
Secondary	Hematological toxicity	Hematological toxicity will be assessed by complete blood counts. Toxicity will be graded according to CTCAE.	Once weekly for an average of 8 months	Yes
Secondary	Renal Toxicity	Renal toxicity will be assessed by changes from baseline creatinin levels. Toxicity will be graded according to CTCAE.	Once weekly for an average of 8 months	Yes
Secondary	Liver Toxicity	Liver toxicity will be assessed by changes from baseline liver function tests, e.g. ASAT/ALAT. Toxicity will be graded according to CTCAE.	Once weekly for an average of 8 months	Yes
Secondary	Correlation of Tumor Necrosis and Decline in PET SUV	Decline in PET SUV will be correlated with grade of histological necrosis in tumor specimen after surgery.	After tumor resection, approx. 12-15 weeks after study inclusion	No
Secondary	Cardiac Toxicity	Changes in cardiac ejection fraction will be assessed by echocardiograms. Toxicities will be graded according to CTCAE.	Every 6 weeks for an average of 8 months	Yes
Secondary	Radiologic Tumor Response	Tumor response to therapy will be assessed by MRI and CT scans. Response will graded according to RECIST criteria.	Every 6 weeks for an average of 8 months, then every 3 months for 2 years	No