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

July 3, 2011 updated by: Oslo University Hospital

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 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

188

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Lund, Sweden, 221 85
        • Recruiting
        • Scandinavian Sarcoma Group centers
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kirsten Sundby Hall, MD,PhD
        • Sub-Investigator:
          • Mikael Eriksson, MD,PhD
    • Lund
      • Lund University Hospital, Lund, Sweden, SE-221 85
        • Recruiting
        • Scandinavian Sarcoma Group Secretariat
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kirsten Sundby Hall, MD,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • Holoxan
  • Doxorubicin
Drug: doxorubicin, ifosfamide
Doxorubicin and Ifosfamide given every three weeks, totally 6 courses.
Other Names:
  • Holoxan
  • Doxorubicin
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:
  • Holoxan
  • Doxorubicin
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:
  • Holoxan
  • Doxorubicin
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:
  • Holoxan
  • Doxorubicin
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:
  • Holoxan
  • Doxorubicin
Drug: doxorubicin, ifosfamide
Doxorubicin and Ifosfamide given every three weeks, totally 6 courses.
Other Names:
  • Holoxan
  • Doxorubicin
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:
  • Holoxan
  • Doxorubicin
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:
  • Holoxan
  • Doxorubicin
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:
  • Holoxan
  • Doxorubicin
Drug: doxorubicin, ifosfamide
Doxorubicin and Ifosfamide given every three weeks, totally 6 courses.
Other Names:
  • Holoxan
  • Doxorubicin
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:
  • Holoxan
  • Doxorubicin
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:
  • Holoxan
  • Doxorubicin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Metastases-free survival
Time Frame: time frame from start of treatment until the events metastases or death of any cause
time frame from start of treatment until the events metastases or death of any cause

Secondary Outcome Measures

Outcome Measure
Time Frame
cumulative incidence of local recurrence,overall survival,acute and late toxicity,secondary malignancies
Time Frame: for ten years from start of treatment
for ten years from start of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (ANTICIPATED)

October 1, 2012

Study Completion (ANTICIPATED)

October 1, 2022

Study Registration Dates

First Submitted

November 12, 2008

First Submitted That Met QC Criteria

November 12, 2008

First Posted (ESTIMATE)

November 13, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

July 6, 2011

Last Update Submitted That Met QC Criteria

July 3, 2011

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EudraCT number 2007-001152-39

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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