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

NCT00790244 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2011-07-06

No results posted yet for this study

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.

Conditions

  • Soft Tissue Sarcoma
  • Non Metastatic Disease

Interventions

DRUG

doxorubicin , ifosfamide

doxorubicin 60mg/m2+ifosfamide 6g/m2 every third week

DRUG

doxorubicin, ifosfamide

Doxorubicin and Ifosfamide given every three weeks, totally 6 courses.

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)

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)

Sponsors & Collaborators

  • Scandinavian Sarcoma Group

    collaborator OTHER

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Kirsten Sundby Hall, MD,PhD · c/o: Scandinavian Sarcoma Group, Southern Swedish Regional Tumor Registry, Lund University Hospital, SE-221 85 Lund

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2012-10-31
Completion
2022-10-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00790244 on ClinicalTrials.gov