A Scandinavian Sarcoma Group Protocol for Patients With High-risk Soft Tissue Sarcoma of the Extremities and Trunk Wall
NCT ID: NCT00790244
Last Updated: 2011-07-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
188 participants
INTERVENTIONAL
2007-10-31
2022-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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)
doxorubicin , ifosfamide
doxorubicin 60mg/m2+ifosfamide 6g/m2 every third week
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)
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)
doxorubicin , ifosfamide
doxorubicin 60mg/m2+ifosfamide 6g/m2 every third week
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)
doxorubicin , ifosfamide
doxorubicin 60mg/m2+ifosfamide 6g/m2 every third week
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)
Arm 1
\<70y: 6 cycles with doxorubicin 60mg/m2+ifosfamide 6g/m2 of each 21day cycle (\>=70y: doxorubicin 50mg/m2+ifosfamide 5g/m2)
doxorubicin , ifosfamide
doxorubicin 60mg/m2+ifosfamide 6g/m2 every third week
doxorubicin, ifosfamide
Doxorubicin and Ifosfamide given every three weeks, totally 6 courses.
Interventions
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doxorubicin , ifosfamide
doxorubicin 60mg/m2+ifosfamide 6g/m2 every third week
doxorubicin, ifosfamide
Doxorubicin and Ifosfamide given every three weeks, totally 6 courses.
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)
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
* 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)
18 Years
75 Years
ALL
Yes
Sponsors
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Scandinavian Sarcoma Group
OTHER
Oslo University Hospital
OTHER
Responsible Party
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Rikshospitalet-Radiumhospitalet HF
Principal Investigators
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Kirsten Sundby Hall, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
c/o: Scandinavian Sarcoma Group, Southern Swedish Regional Tumor Registry, Lund University Hospital, SE-221 85 Lund
Locations
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Scandinavian Sarcoma Group centers
Lund, Lund, Sweden
Scandinavian Sarcoma Group Secretariat
Lund University Hospital, Lund, Sweden
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
Related Links
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Scandinavian Sarcoma Group
Other Identifiers
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EudraCT number 2007-001152-39
Identifier Type: -
Identifier Source: org_study_id
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