A Scandinavian Sarcoma Group Protocol for Patients With High-Risk Soft Tissue Sarcoma of the Extremities and Trunk Wall - Full Text View

Sponsors and Collaborators:	Rikshospitalet HF Scandinavian Sarcoma Group
Information provided by:	Rikshospitalet HF
ClinicalTrials.gov Identifier:	NCT00790244

Purpose

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.

Condition	Intervention	Phase
Soft Tissue Sarcoma Non Metastatic Disease	Drug: doxorubicin , ifosfamide Drug: doxorubicin, ifosfamide	Phase II

MedlinePlus related topics: Cancer Soft Tissue Sarcoma

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Ifosfamide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Scandinavian Sarcoma Group Treatment Protocol for Adult Patients With Non-Metastatic High-Risk Soft Tissue Sarcoma of the Extremities and Trunk Wall

Further study details as provided by Rikshospitalet HF:

Primary Outcome Measures:

Metastases-free survival [ Time Frame: time frame from start of treatment until the events metastases or death of any cause ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

cumulative incidence of local recurrence,overall survival,acute and late toxicity,secondary malignancies [ Time Frame: for ten years from start of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	188
Study Start Date:	October 2007
Estimated Study Completion Date:	October 2022
Estimated Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 , ifosfamide doxorubicin 60mg/m2+ifosfamide 6g/m2 every third week 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)
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 doxorubicin 60mg/m2+ifosfamide 6g/m2 every third week
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 , ifosfamide doxorubicin 60mg/m2+ifosfamide 6g/m2 every third week 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)
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 , ifosfamide doxorubicin 60mg/m2+ifosfamide 6g/m2 every third week Drug: doxorubicin, ifosfamide Doxorubicin and Ifosfamide given every three weeks, totally 6 courses.

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00790244

Contacts

Contact: Kirsten Sundby Hall, MD, PhD	+4722934000	k.s.hall@klinmed.uio.no
Contact: Mikael Eriksson, MD,PhD	+4646177507	mikael.eriksson@onk.lu.se

Locations

Sweden
Scandinavian Sarcoma Group centers	Recruiting
Lund, Sweden, 221 85
Contact: Kirsten Sundby Hall, MD, PhD +4722934000 k.s.hall@klinmed.uio.no
Contact: Mikael Eriksson, MD,PhD +4646177507 mikael.eriksson@onk.lu.se
Principal Investigator: Kirsten Sundby Hall, MD,PhD
Sub-Investigator: Mikael Eriksson, MD,PhD
Sweden, Lund
Scandinavian Sarcoma Group Secretariat	Recruiting
Lund University Hospital, Lund, Sweden, SE-221 85
Contact: Kirsten Sundby Hall, MD,PhD +4722934000 k.s.hall@klinmed.uio.no
Contact: Mikael Eriksson, MD,PhD +4646 177507 mikael.eriksson@onk.lu.se
Principal Investigator: Kirsten Sundby Hall, MD,PhD

Sponsors and Collaborators

Rikshospitalet HF

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

More Information

Scandinavian Sarcoma Group This link exits the ClinicalTrials.gov site

Publications:

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. Epub 2007 Jul 12.

Engellau J, Bendahl PO, Persson A, Domanski HA, Akerman M, Gustafson P, Alvegård 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.

Responsible Party:	Rikshospitalet-Radiumhospitalet HF ( Kirsten Sundby Hall )
Study ID Numbers:	EudraCT number 2007-001152-39
Study First Received:	November 12, 2008
Last Updated:	November 12, 2008
ClinicalTrials.gov Identifier:	NCT00790244
Health Authority:	Norway: The National Committees for Research Ethics in Norway; Norway: Norwegian Medicines Agency; Norway: Norwegian Social Science Data Services; Norway: Directorate for Health and Social Affairs

Keywords provided by Rikshospitalet HF:

Soft-tissue sarcomas
prognostic factors
adjuvant
chemotherapy
radiotherapy

metastases-free survival
toxicity
High malignancy grade
High-risk for metastases
Adult

Study placed in the following topic categories:

Neoplasms, Connective and Soft Tissue
Ifosfamide
Mechlorethamine
Malignant mesenchymal tumor
Neoplasm Metastasis

Sarcoma
Doxorubicin
Soft tissue sarcomas
Isophosphamide mustard

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

Antineoplastic Agents, Alkylating
Antibiotics, Antineoplastic
Alkylating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009