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

This study is currently recruiting participants.
Verified November 2008 by Oslo University Hospital
Sponsor:
Collaborator:
Scandinavian Sarcoma Group
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00790244
First received: November 12, 2008
Last updated: July 3, 2011
Last verified: November 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Soft Tissue Sarcoma
Non Metastatic Disease
 Drug: doxorubicin , ifosfamide
Drug: doxorubicin, ifosfamide
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Metastases-free survival [ Time Frame: time frame from start of treatment until the events metastases or death of any cause ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • cumulative incidence of local recurrence,overall survival,acute and late toxicity,secondary malignancies [ Time Frame: for ten years from start of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 188
Study Start Date: October 2007
Estimated Study Completion Date: October 2022
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 2

<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 4.

(>=70y: doxorubicin 50mg/m2+ifosfamide 5g/m2)

 Drug: doxorubicin , ifosfamide
doxorubicin 60mg/m2+ifosfamide 6g/m2 every third week
Other Names:
  • Doxorubicin
  • Holoxan
Drug: 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)

Other Names:
  • Doxorubicin
  • Holoxan
Experimental: Arm 3

<70y: 6 cycles with doxorubicin 60mg/m2+ifosfamide 6g/m2 of each 21day cycle and radiotherapy 45Gy (1.8Gy per fraction, two fractions daily) will be given between cycle 3 and 4.

(>=70y: doxorubicin 50mg/m2+ifosfamide 5g/m2)

 Drug: doxorubicin , ifosfamide
doxorubicin 60mg/m2+ifosfamide 6g/m2 every third week
Other Names:
  • Doxorubicin
  • Holoxan
Experimental: Group B

<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)

 Drug: doxorubicin , ifosfamide
doxorubicin 60mg/m2+ifosfamide 6g/m2 every third week
Other Names:
  • Doxorubicin
  • Holoxan
Drug: 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)

Other Names:
  • Doxorubicin
  • Holoxan
Experimental: Arm 1
<70y: 6 cycles with doxorubicin 60mg/m2+ifosfamide 6g/m2 of each 21day cycle (>=70y: doxorubicin 50mg/m2+ifosfamide 5g/m2)
 Drug: doxorubicin , ifosfamide
doxorubicin 60mg/m2+ifosfamide 6g/m2 every third week
Other Names:
  • Doxorubicin
  • Holoxan
Drug: doxorubicin, ifosfamide
Doxorubicin and Ifosfamide given every three weeks, totally 6 courses.
Other Names:
  • Doxorubicin
  • Holoxan

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00790244

Contacts
Contact: Kirsten Sundby Hall, MD, PhD +4722934000 k.s.hall@klinmed.uio.no
Contact: Mikael Eriksson, MD,PhD +4646177507 mikael.eriksson@onk.lu.se

Locations
Sweden
Scandinavian Sarcoma Group Secretariat Recruiting
Lund University Hospital, Lund, Sweden, SE-221 85
Contact: Kirsten Sundby Hall, MD,PhD     +4722934000     k.s.hall@klinmed.uio.no    
Contact: Mikael Eriksson, MD,PhD     +4646 177507     mikael.eriksson@onk.lu.se    
Principal Investigator: Kirsten Sundby Hall, MD,PhD            
Scandinavian Sarcoma Group centers Recruiting
Lund, Sweden, 221 85
Contact: Kirsten Sundby Hall, MD, PhD     +4722934000     k.s.hall@klinmed.uio.no    
Contact: Mikael Eriksson, MD,PhD     +4646177507     mikael.eriksson@onk.lu.se    
Principal Investigator: Kirsten Sundby Hall, MD,PhD            
Sub-Investigator: Mikael Eriksson, MD,PhD            
Sponsors and Collaborators
Oslo University Hospital
Scandinavian Sarcoma Group
Investigators
Principal Investigator: Kirsten Sundby Hall, MD,PhD c/o: Scandinavian Sarcoma Group, Southern Swedish Regional Tumor Registry, Lund University Hospital, SE-221 85 Lund
  More Information

Additional Information:
Scandinavian Sarcoma Group  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Kirsten Sundby Hall, Rikshospitalet-Radiumhospitalet HF
ClinicalTrials.gov Identifier: NCT00790244     History of Changes
Other Study ID Numbers: EudraCT number 2007-001152-39
Study First Received: November 12, 2008
Last Updated: July 3, 2011
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Medicines Agency
Norway: Norwegian Social Science Data Services
Norway: Directorate of Health

Keywords provided by Oslo University Hospital:
Soft-tissue sarcomas
prognostic factors
adjuvant
chemotherapy
radiotherapy
 metastases-free survival
toxicity
High malignancy grade
High-risk for metastases
Adult

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Doxorubicin
Isophosphamide mustard
Ifosfamide
 Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013