A Scandinavian Sarcoma Group treatment protocol for adult patients with non-metastatic high-risk soft tissue sarcoma of the extremities and trunk wall

• Conditions: SSG XX is a phase II trial for high-risk soft tissue sarcoma(STS) of the extremities and trunk wall. Prognostic markers are used to identify high-risk tumors. SSG XX will evaluate chemo-and radiotherapy given adjuvantly to these patients. In a specified group of patients also preoperatively given therapy will be studied.

• Registration Number: EUCTR2007-001152-39-SE
• Lead Sponsor: Scandinavian Sarcoma Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-04
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 188

Inclusion Criteria

a) Age = 18 years and <75 years
b) Performance status, WHO: 0 or 1(or higher if this is a consequence of sarcoma-related decreased motility)
c) White blood count = 3.0 x 109/l or neutrophiles =1.0 x 109/l and thrombocytes = 100 x 109/l
d) GFR = 70ml/min/1.73m2
e) ALAT and total bilirubin < 2 times normal upper limit
f) Adequate cardiac function (LVEF = 50%)
g) Extremity or trunk wall localization
h) Patients fulfilling the high-risk criteria defined above, section 4.2.1 and 4.2.2.
i) All histiotypes except: extraskeletal osteosarcoma and chondrosarcoma, Ewing, PNET, rhabdomyosarcoma, Kaposi`s sarcoma, malignant mesenchymoma, clear cell sarcoma, alveolar soft part sarcoma, epithelioid sarcoma
j) Not radiation induced sarcoma
k) No metastases diagnosed contemporary with the diagnosis of the primary tumor
l) At least 5 years free of another non-metastatic malignancy, except basal cell skin cancer or cervical carcinoma in situ
m) No previous anthracycline treatment
n) Not given any other treatment for this sarcoma including isolated limb perfusion with
TNF-alpha and melphalan (ILP)
o) Not pregnant or lactating
p) Time frames:
Group A(operated initially): Not more than 12 weeks (84 days) between final surgery and start of chemotherapy. Not more than 3 weeks (21 days) between registration and start of chemotherapy. Note that no chemotherapy may be given before registration!
Group B(not operated initially): Not more than 4 weeks (28 days) from diagnostic biopsy to start of chemotherapy subsequent to registration. Not more than 3 weeks (21 days) between registration and start of chemotherapy.
q) Written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Not fulfilling the inclusion criteria above

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified