A Scandinavian Sarcoma Group Treatment Protocol for Adult Patients With Non-metastatic High-risk Soft Tissue Sarcoma of the Extremities and Trunk Wall
SSG XX, the third adjuvant STS protocol by SSG, is a phase II non-randomized trial in
patients with high risk to develop metastases. SSG XX is based on a previous SSG trial (SSG
XIII) regarding use of prognostic markers to identify high-risk tumors and include very
similar chemo- and radiotherapy treatment schedules compared to SSG XIII, but the new
protocol also includes a treatment arm with preoperative chemo- and radiotherapy for
patients with an obvious risk for intralesional surgery initially.
Patients: In this new adjuvant protocol SSG adopts an inclusion decision algorithm based on
the following criteria: 1.vascular invasion or 2. presence of at least two of the risk
factors: tumor size =>8 cm, necrosis or infiltrative growth(all defined microscopically by
the pathologist. The system was developed retrospectively by evaluation of 434 primary
histologically high grade (III-IV) STS from the SSG registry, and was later validated in a
series of 175 patients in which patients with a high risk for metastases (>40 %) and low
risk (<15 %) were separated (Engellau J et al.Eur J Ca 2007 43: 1927-34). Inclusion
criteria: age ≥ 18 y and <75 y. Primary end point is metastasis-free survival. Local
recurrence and toxicity will also be studied.
Treatment: Six cycles of doxorubicin 60mg/m2 and ifosfamide 6g/m2 will be given adjuvantly
(to patients ≥ 70y: 50mg/m2 and 5g/m2 ). Dependent on surgical resection margins, 36Gy or
45Gy (1,8Gy per fraction, two fractions daily) will be given interpolated with chemotherapy.
Conclusion: SSG XX will evaluate chemo-and radiotherapy given adjuvantly to patients with
STS and high risk for metastases (arm A). In a specified group of patients also
preoperatively given therapy will be studied(arm B). Other sarcoma centers are invited to
participate in the study.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
time frame from start of treatment until the events metastases or death of any cause
Kirsten Sundby Hall, MD,PhD
c/o: Scandinavian Sarcoma Group, Southern Swedish Regional Tumor Registry, Lund University Hospital, SE-221 85 Lund
Norway:National Committee for Medical and Health Research Ethics
EudraCT number 2007-001152-39