Soft Tissue SarcomaPhase 2SSGXXNCT00790244
A Scandinavian Sarcoma Group Protocol for Patients With High-risk Soft Tissue Sarcoma of the Extremities and Trunk Wall
A Phase 2 study testing doxorubicin , ifosfamide and doxorubicin, ifosfamide in people with Soft Tissue Sarcoma and Non Metastatic Disease, run by Oslo University Hospital at 2 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Soft Tissue Sarcoma, Non Metastatic Disease
- What is being tested?
- doxorubicin , ifosfamide and doxorubicin, ifosfamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 2 sitesSweden
- Study dates
- Oct 2007to Oct 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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%)
Show all 9Show fewer
- Normal GFR (clearance)
- Adequate haematologic and liver function
- All histotypes except those listed below
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites, 2 recruiting
- Recruiting
Scandinavian Sarcoma Group centers
Lund, Lund, 221 85
Kirsten Sundby Hall, MD, PhD, +4722934000, k.s.hall@klinmed.uio.no
Mikael Eriksson, MD,PhD, +4646177507, mikael.eriksson@onk.lu.se
- Recruiting
Scandinavian Sarcoma Group Secretariat
Lund University Hospital, Lund, SE-221 85
Kirsten Sundby Hall, MD,PhD, +4722934000, k.s.hall@klinmed.uio.no
Mikael Eriksson, MD,PhD, +4646 177507, mikael.eriksson@onk.lu.se
About this 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
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.
Read the 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.
- Conditions
- Soft Tissue Sarcoma, Non Metastatic Disease
- Being tested
- doxorubicin , ifosfamide, doxorubicin, ifosfamide
- Keywords
- Soft-tissue sarcomas, prognostic factors, adjuvant, chemotherapy, radiotherapy, metastases-free survival, toxicity, High malignancy grade, High-risk for metastases, Adult
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
doxorubicin , ifosfamideDrug
Also called Doxorubicin, Holoxan
doxorubicin 60mg/m2+ifosfamide 6g/m2 every third week
doxorubicin, ifosfamideDrug
Also called Doxorubicin, Holoxan
Doxorubicin and Ifosfamide given every three weeks, totally 6 courses.
doxorubicin, ifosfamideDrug
Also called Doxorubicin, Holoxan
<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, ifosfamideDrug
Also called Doxorubicin, Holoxan
<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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: doxorubicin , ifosfamide; Drug: 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) Receives: 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) Receives: Drug: doxorubicin , ifosfamide; Drug: 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) Receives: Drug: doxorubicin , ifosfamide; Drug: doxorubicin, ifosfamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metastases-free survival
Measured: 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
Measured: for ten years from start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2008 (estimated)
- Study startOct 2007
- Primary completionOct 2012 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Soft Tissue SarcomaStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Scandinavian Sarcoma Group
- Investigators
- Kirsten Sundby Hall, MD,PhD, Principal investigator, c/o: Scandinavian Sarcoma Group, Southern Swedish Regional Tumor Registry, Lund University Hospital, SE-221 85 Lund
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00790244
- Sponsor's protocol ID
- EudraCT number 2007-001152-39
- Acronym
- SSGXX
- Status last verified
- Nov 2008
- First submitted
- 12 Nov 2008
- Last updated
- 6 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1016/j.ejca.2007.05.018. Epub 2007 Jul 12.
PubMed 17627813Engellau 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.
PubMed 16153463Hall 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.
PubMed 33292545Sundby 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.
PubMed 29929092
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00790244
- Acronym / sponsor ID
- SSGXX / EudraCT number 2007-001152-39
- Conditions
- Soft Tissue Sarcoma, Non Metastatic Disease
- Keywords
- Soft-tissue sarcomas, prognostic factors, adjuvant, chemotherapy, radiotherapy, metastases-free survival, toxicity, High malignancy grade
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Scandinavian Sarcoma Group
- Study start
- Oct 2007
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 13 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 2 | Experimental | Drug: doxorubicin , ifosfamide, 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 4. (>=70y: doxorubicin 50mg/m2+ifosfamide 5g/m2) |
| Arm 3 | Experimental | Drug: doxorubicin , ifosfamide<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) |
| Group B | Experimental | Drug: doxorubicin , ifosfamide, 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 | Drug: doxorubicin , ifosfamide, Drug: doxorubicin, ifosfamide<70y: 6 cycles with doxorubicin 60mg/m2+ifosfamide 6g/m2 of each 21day cycle (>=70y: doxorubicin 50mg/m2+ifosfamide 5g/m2) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| doxorubicin , ifosfamideAlso: Doxorubicin, Holoxandoxorubicin 60mg/m2+ifosfamide 6g/m2 every third week | Drug | Arm 1, Arm 2, Arm 3, Group B |
| doxorubicin, ifosfamideAlso: Doxorubicin, HoloxanDoxorubicin and Ifosfamide given every three weeks, totally 6 courses. | Drug | Arm 1 |
| doxorubicin, ifosfamideAlso: Doxorubicin, Holoxan<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 | Arm 2 |
| doxorubicin, ifosfamideAlso: Doxorubicin, Holoxan<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 | Group B |
Primary outcome
Metastases-free survival
Time frame: time frame from start of treatment until the events metastases or death of any cause
1 secondary outcome
cumulative incidence of local recurrence,overall survival,acute and late toxicity,secondary malignancies
Time frame: for ten years from start of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2011.
- Background: PubMed 17627813Engellau 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.
- Background: PubMed 16153463Engellau 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.
- Derived from this study: PubMed 33292545Hall 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.
- Derived from this study: PubMed 29929092Sundby 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.
- Scandinavian Sarcoma GroupLink provided by the sponsor.
Related trials for Soft Tissue Sarcoma
RecruitingPhase 3
Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas
Metastatic Dedifferentiated Liposarcoma, Metastatic Undifferentiated Pleomorphic Sarcoma
Active, not recruitingPhase 3
Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing Sarcoma
Metastatic Ewing Sarcoma, Metastatic Malignant Neoplasm in the Bone
Active, not recruitingPhase 2
A Study of Etrumadenant and Zimberelimab in People With Dedifferentiated Liposarcoma
Dedifferentiated Liposarcoma, Soft Tissue Sarcoma
RecruitingPhase 1
A Study of SHY-ONC6, a Novel Proteasome Inhibitor, in Adults With Advanced or Metastatic Solid Tumors
Advanced or Metastatic Solid Tumors, Triple Negative Breast Cancer (TNBC)
RecruitingPhase 1
Preliminary Clinical Study of Entinostat in Children With Malignant Soft Tissue Sarcoma Harboring PAX-family Gene Abnormalities
Soft Tissue Sarcoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsten Sundby Hall, MD,PhD principal investigator
c/o: Scandinavian Sarcoma Group, Southern Swedish Regional Tumor Registry, Lund University Hospital, SE-221 85 Lund
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing doxorubicin , ifosfamide and doxorubicin, ifosfamide in people with Soft Tissue Sarcoma and Non Metastatic Disease, run by Oslo University Hospital at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kirsten Sundby Hall, MD, PhD (+4722934000, k.s.hall@klinmed.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metastases-free survival (time frame: time frame from start of treatment until the events metastases or death of any cause). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00790244, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2011; AzTrials last refreshed its copy on 26 Oct 2026.