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A Scandinavian Sarcoma Group Treatment Protocol for Adult Patients With Non-metastatic High-risk Soft Tissue Sarcoma of the Extremities and Trunk Wall


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Soft Tissue Sarcoma, Non Metastatic Disease

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Trial Information

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.


Inclusion Criteria:



Group A: Histological high-grade malignancy soft tissue sarcomas of the extremity and
trunk wall.

Patients fulfilling the high-risk criteria defined above (see detailed description) Group
B: Patients with histological high-grade malignancy soft tissue sarcomas of the extremity
and trunk wall for whom surgery carries an obvious risk of intralesional margin

Other inclusion criteria for therapy group A and group B

- Age ≥ 18 y and ≤ 75 y

- WHO grade 0-1

- Adequate cardiac function (LVEF ≥ 50%)

- Normal GFR (clearance)

- Adequate haematologic and liver function

- All histotypes except those listed below

Exclusion Criteria:

The following histological types:

- Extraskeletal osteosarcoma and - chondrosarcoma, Ewing/PNET,
rhabdomyosarcoma, Kaposi´s sarcoma, malignant mesenchymoma, clear cell sarcoma,
alveolar soft part sarcoma, epithelioid sarcoma

- Radiation induced sarcoma

- No previous anthracycline treatment

- Less than 5 years free of another primary malignancy

- More than 12 weeks have elapsed since primary surgery (Group A)

- More than 4 weeks from diagnostic biopsy to start of chemotherapy (Group B)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Metastases-free survival

Outcome Time Frame:

time frame from start of treatment until the events metastases or death of any cause

Safety Issue:

No

Principal Investigator

Kirsten Sundby Hall, MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

c/o: Scandinavian Sarcoma Group, Southern Swedish Regional Tumor Registry, Lund University Hospital, SE-221 85 Lund

Authority:

Norway:National Committee for Medical and Health Research Ethics

Study ID:

EudraCT number 2007-001152-39

NCT ID:

NCT00790244

Start Date:

October 2007

Completion Date:

October 2022

Related Keywords:

  • Soft Tissue Sarcoma
  • Non Metastatic Disease
  • Soft-tissue sarcomas
  • prognostic factors
  • adjuvant
  • chemotherapy
  • radiotherapy
  • metastases-free survival
  • toxicity
  • High malignancy grade
  • High-risk for metastases
  • Adult
  • Sarcoma

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