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

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ClinicalTrials.gov Identifier: NCT00790244
Recruitment Status : Recruiting
First Posted : November 13, 2008
Last Update Posted : July 6, 2011
Sponsor:
Collaborator:
Scandinavian Sarcoma Group
Information provided by:
Oslo University Hospital

Tracking Information
First Submitted Date  ICMJE November 12, 2008
First Posted Date  ICMJE November 13, 2008
Last Update Posted Date July 6, 2011
Study Start Date  ICMJE October 2007
Estimated Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 12, 2008)
Metastases-free survival [ Time Frame: time frame from start of treatment until the events metastases or death of any cause ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2008)
cumulative incidence of local recurrence,overall survival,acute and late toxicity,secondary malignancies [ Time Frame: for ten years from start of treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Scandinavian Sarcoma Group Protocol for Patients With High-risk Soft Tissue Sarcoma of the Extremities and Trunk Wall
Official Title  ICMJE A Scandinavian Sarcoma Group Treatment Protocol for Adult Patients With Non-metastatic High-risk Soft Tissue Sarcoma of the Extremities and Trunk Wall
Brief 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Soft Tissue Sarcoma
  • Non Metastatic Disease
Intervention  ICMJE
  • 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
  • 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
  • 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
Study Arms  ICMJE
  • 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)

    Interventions:
    • Drug: doxorubicin , ifosfamide
    • Drug: doxorubicin, ifosfamide
  • 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)

    Intervention: Drug: doxorubicin , ifosfamide
  • 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)

    Interventions:
    • Drug: doxorubicin , ifosfamide
    • Drug: doxorubicin, ifosfamide
  • Experimental: Arm 1
    <70y: 6 cycles with doxorubicin 60mg/m2+ifosfamide 6g/m2 of each 21day cycle (>=70y: doxorubicin 50mg/m2+ifosfamide 5g/m2)
    Interventions:
    • Drug: doxorubicin , ifosfamide
    • Drug: doxorubicin, ifosfamide
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 12, 2008)
188
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2022
Estimated Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Kirsten Sundby Hall, MD, PhD +4722934000 k.s.hall@klinmed.uio.no
Contact: Mikael Eriksson, MD,PhD +4646177507 mikael.eriksson@onk.lu.se
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00790244
Other Study ID Numbers  ICMJE EudraCT number 2007-001152-39
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kirsten Sundby Hall, Rikshospitalet-Radiumhospitalet HF
Study Sponsor  ICMJE Oslo University Hospital
Collaborators  ICMJE Scandinavian Sarcoma Group
Investigators  ICMJE
Principal Investigator: Kirsten Sundby Hall, MD,PhD c/o: Scandinavian Sarcoma Group, Southern Swedish Regional Tumor Registry, Lund University Hospital, SE-221 85 Lund
PRS Account Oslo University Hospital
Verification Date November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP