NCT00790244

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
188

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2007

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 12, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 13, 2008

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

July 6, 2011

Status Verified

November 1, 2008

Enrollment Period

5 years

First QC Date

November 12, 2008

Last Update Submit

July 3, 2011

Conditions

Soft Tissue SarcomaNon Metastatic Disease

Keywords

Soft-tissue sarcomasprognostic factorsadjuvantchemotherapyradiotherapymetastases-free survivaltoxicityHigh malignancy gradeHigh-risk for metastasesAdult

Outcome Measures

Primary Outcomes (1)

  • Metastases-free survival

    time frame from start of treatment until the events metastases or death of any cause

Secondary Outcomes (1)

  • cumulative incidence of local recurrence,overall survival,acute and late toxicity,secondary malignancies

    for ten years from start of treatment

Study Arms (4)

Arm 2

EXPERIMENTAL

\<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 , ifosfamideDrug: doxorubicin, ifosfamide

Arm 3

EXPERIMENTAL

\<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

Group B

EXPERIMENTAL

\<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 , ifosfamideDrug: doxorubicin, ifosfamide

Arm 1

EXPERIMENTAL

\<70y: 6 cycles with doxorubicin 60mg/m2+ifosfamide 6g/m2 of each 21day cycle (\>=70y: doxorubicin 50mg/m2+ifosfamide 5g/m2)

Drug: doxorubicin , ifosfamideDrug: doxorubicin, ifosfamide

Interventions

doxorubicin, ifosfamideDRUG

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

Also known as: Doxorubicin, Holoxan
Arm 1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Scandinavian Sarcoma Group centers

Lund, Lund, 221 85, Sweden

RECRUITING

Scandinavian Sarcoma Group Secretariat

Lund University Hospital, Lund, SE-221 85, Sweden

RECRUITING

Related Publications (4)

  • 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. doi: 10.1016/j.ejca.2007.05.018. Epub 2007 Jul 12.

    PMID: 17627813BACKGROUND

  • Engellau J, Bendahl PO, Persson A, Domanski HA, Akerman M, Gustafson P, Alvegard 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. doi: 10.1016/j.humpath.2005.07.008.

    PMID: 16153463BACKGROUND

  • Hall KS, Bruland OS, Bjerkehagen B, Lidbrink E, Jebsen N, Hagberg H, Papworth K, Hagberg O, Trovik C, Bauer H, Eriksson M. Preoperative accelerated radiotherapy combined with chemotherapy in a defined cohort of patients with high risk soft tissue sarcoma: a Scandinavian Sarcoma Group study. Clin Sarcoma Res. 2020 Nov 17;10(1):22. doi: 10.1186/s13569-020-00145-5.

    PMID: 33292545DERIVED

  • Sundby Hall K, Bruland OS, Bjerkehagen B, Zaikova O, Engellau J, Hagberg O, Hansson L, Hagberg H, Ahlstrom M, Knobel H, Papworth K, Zemmler M, Goplen D, Bauer HCF, Eriksson M. Adjuvant chemotherapy and postoperative radiotherapy in high-risk soft tissue sarcoma patients defined by biological risk factors-A Scandinavian Sarcoma Group study (SSG XX). Eur J Cancer. 2018 Aug;99:78-85. doi: 10.1016/j.ejca.2018.05.011. Epub 2018 Jun 19.

    PMID: 29929092DERIVED

Related Links

MeSH Terms

Conditions

Sarcoma

Interventions

DoxorubicinIfosfamide

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

DaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesCyclophosphamidePhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus CompoundsOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Kirsten Sundby Hall, MD,PhD

    c/o: Scandinavian Sarcoma Group, Southern Swedish Regional Tumor Registry, Lund University Hospital, SE-221 85 Lund

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kirsten Sundby Hall, MD, PhD

CONTACT

+4722934000k.s.hall@klinmed.uio.no

Mikael Eriksson, MD,PhD

CONTACT

+4646177507mikael.eriksson@onk.lu.se

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 12, 2008

First Posted

November 13, 2008

Study Start

October 1, 2007

Primary Completion

October 1, 2012

Study Completion

October 1, 2022

Last Updated

July 6, 2011

Record last verified: 2008-11

Locations

SE(2)