Neoplasms

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Sarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

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Doxorubicin

Liposomal doxorubicin

Ifosfamide

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Alkylating Agents

\<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)

\<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)

\<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)

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

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)

Kirsten Sundby Hall, MD, PhD

Mikael Eriksson, MD,PhD

Kirsten Sundby Hall, MD,PhD

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.

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 title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Scandinavian Sarcoma Group Protocol for Patients With High-risk Soft Tissue Sarcoma of the Extremities and Trunk Wall	NCT00790244	Soft Tissue Sar... Non Metastatic ...	doxorubicin , i... doxorubicin, if... doxorubicin, if... doxorubicin, if...	18 Years - 75 Years	Oslo University Hospital
A Scandinavian Sarcoma Group Protocol for Patients With High-risk Soft Tissue Sarcoma of the Extremities and Trunk Wall	NCT00790244	Soft Tissue Sar... Non Metastatic ...	doxorubicin , i... doxorubicin, if... doxorubicin, if... doxorubicin, if...	18 Years - 75 Years	Oslo University Hospital

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