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

Soft Tissue Sarcoma Clinical Trial

— SSGXX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00790244
• Other study ID #: EudraCT number 2007-001152-39
• Status: Recruiting
• Phase: Phase 2
• First received: November 12, 2008
• Last updated: July 3, 2011
• Start date: October 2007
• Est. completion date: October 2022

Study information

• Verified date: November 2008
• Source: Oslo University Hospital
• Contact: Kirsten Sundby Hall, MD, PhD
• Phone: +4722934000
• Email: k.s.hall[@]klinmed.uio.no
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Norwegian Medicines AgencyNorway: Norwegian Social Science Data ServicesNorway: Directorate of Health
• Study type: Interventional

Clinical Trial Summary

SSG XX is a phase II trial for high-risk soft tissue sarcomas (STS) of the extremities and trunk wall. Prognostic factors (histopathological 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 188
• Est. completion date: October 2022
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Non Metastatic Disease
• Sarcoma
• Soft Tissue Sarcoma

Intervention

Drug:
• doxorubicin , ifosfamide
doxorubicin 60mg/m2+ifosfamide 6g/m2 every third week
• doxorubicin, ifosfamide
Doxorubicin and Ifosfamide given every three weeks, totally 6 courses.
• doxorubicin, ifosfamide
<70y: 6 cycles with doxorubicin 60mg/m2+ifosfamide 6g/m2 of each 21day cycle and radiotherapy 36Gy (1.8Gy per fraction, two fractions daily) will be given between cycle 3 and four. (>=70y: doxorubicin 50mg/m2+ifosfamide 5g/m2)
• doxorubicin, ifosfamide
<70y: 6 cycles with doxorubicin 60mg/m2+ifosfamide 6g/m2 of each 21day cycle and radiotherapy 36Gy (1.8Gy per fraction, two fractions daily) will be given between cycle 2 and 3. (>=70y: doxorubicin 50mg/m2+ifosfamide 5g/m2)

Locations

Country	Name	City	State
Sweden	Scandinavian Sarcoma Group centers	Lund
Sweden	Scandinavian Sarcoma Group Secretariat	Lund University Hospital	Lund

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Scandinavian Sarcoma Group

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

Engellau J, Bendahl PO, Persson A, Domanski HA, Akerman M, Gustafson P, Alvegård TA, Nilbert M, Rydholm A. Improved prognostication in soft tissue sarcoma: independent information from vascular invasion, necrosis, growth pattern, and immunostaining using whole-tumor sections and tissue microarrays. Hum Pathol. 2005 Sep;36(9):994-1002. — View Citation

Engellau J, Samuelsson V, Anderson H, Bjerkehagen B, Rissler P, Sundby-Hall K, Rydholm A. Identification of low-risk tumours in histological high-grade soft tissue sarcomas. Eur J Cancer. 2007 Sep;43(13):1927-34. Epub 2007 Jul 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metastases-free survival		time frame from start of treatment until the events metastases or death of any cause	No
Secondary	cumulative incidence of local recurrence,overall survival,acute and late toxicity,secondary malignancies		for ten years from start of treatment	No

External Links

•   Scandinavian Sarcoma Group