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.
Conditions
Interventions
Trade Name: Marketing authorisation holders are not fixed in the protocol - varies in different countries, go to section D.2.2
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN
Sponsors
Scandinavian Sarcoma Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) Age = 18 years and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Not fulfilling the inclusion criteria above
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to study the risk of metastases and death for the present protocol treatment, as reflected by metastasis-free survival;Secondary Objective: - cumulative incidence of local recurrence - overall survival - tumor progression during preoperative treatment in patients not initially operated (group B) - acute and late toxicity in relation to chemotherapy, and radiation morbidity - secondary malignancies. - surgical margin and group allocation, in all patients, and by center. ;Primary end point(s): - is metastases-free survival defined as time from start of treatment (surgery for group A and chemotherapy for group B) until the first of the events metastases or death of any cause. | — |
Countries
Norway, Sweden
Outcome results
None listed