Soft Tissue Sarcoma of the LimbPhase 2PREMISSNCT01552239
Preoperative Radiotherapy for Sarcomas of the Extremities With Intensity-Modulation, Image-Guidance and Small Safety-margins
A Phase 2 study testing IMRT/IGRT, Tumor resection, Brachytherapy in people with Soft Tissue Sarcoma of the Limb and AJCC Stage II and III, run by Technical University of Munich at 1 site in Germany.
Trial summary
RATIONALE: Modern radiotherapy techniques in a neoadjuvant setting have the potential to minimize morbidity and maximize efficacy. An additional boost dose can be provided locally by HDR-brachytherapy in patients with positive margins after tumor resection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Sarcoma of the Limb, AJCC Stage II and III
- What is being tested?
- IMRT/IGRT, Tumor resection, Brachytherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2011to Oct 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic and radiographic proof of localized high-risk soft tissue sarcoma meeting the following criteria:
- Lesion originates in extremity
- upper extremity lesions may occur from the medial border of the scapula to tumors as far distal as the finger tips
- lower extremity regions include hip girdle tumors commencing at the iliac crest, excluding lesions arising from within the pelvis, and extends to include lesions as far distal as the toes
- AJCC Stage II or III disease (except T1a-tumors or N1)
- Primary presentation or local recurrence
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- after biopsy or inadequate surgery resulting in residual tumor in cross-sectional imaging
- Tumors must be considered resectable according to cross sectional imaging, or potentially resectable after preoperative radiotherapy
- ECOG Performance Status 0-2
- Informed Consent
Who cannot join
- Diagnosis of the following:
- Primitive neuroectodermal tumor
- Soft tissue Ewing's sarcoma
- Extraskeletal osteo- or chondrosarcoma
- Aggressive fibromatosis (desmoid tumors)
- Dermatofibrosarcoma protuberans
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- Regional nodal disease or unequivocal distant metastasis
- Life expectancy < 1 year
- Pregnancy
- Major medical illness that would preclude study treatment
- History of major wound complication or recurrent skin infection
- Known HIV positivity
- < 2 weeks elapsed from prior surgery or cytotoxic chemotherapy
- persisting acute toxicities > grade 1 in tumor-bearing limb resulting from prior treatment with anti-cancer modalities
- Cytotoxic chemotherapy, targeted therapy or investigational agents concurrent to study treatment
- Prior radiotherapy to the site of present STS.
- Chronic requirement for treatment with immuno¬suppressive agents or steroids.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Klinikum rechts der Isar
Munich, 81675
Barbara Röper, MD, 49-89-4140 ext. 4502, barbara.roeper@lrz.tu-muenchen.de
Michael Molls, MD
About this study
Official title: Phase II Study of Preoperative Radiotherapy for Sarcomas of the Extremities With Intensity-Modulation, Image-Guidance, Small Safety-margins and Brachytherapy Conditioned by Resection Margin
RATIONALE: Modern radiotherapy techniques in a neoadjuvant setting have the potential to minimize morbidity and maximize efficacy. An additional boost dose can be provided locally by HDR-brachytherapy in patients with positive margins after tumor resection.
PURPOSE: This phase II trial is studying the safety and efficacy of a combination of modern radiotherapy elements applied to the tumor and small volumes of surrounding normal tissue (IMRT, IGRT; brachytherapy in case of positive resection margin) and see how well it works in treating patients with High-Risk Soft Tissue Sarcoma of the Extremities.
- Being tested
- IMRT/IGRT, Tumor resection, Brachytherapy
- Keywords
- Soft tissue sarcoma, Intensity-Modulated Radiation Therapy (IMRT), Tomotherapy, Safety Margins, Image-guided Radiation Therapy, Brachytherapy, interstitial
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMRT/IGRT, Tumor resection, BrachytherapyRadiation
All:
Preoperative IMRT with small safety margins (GTV according to MRT plus 1.5cm laterally / 3cm proximodistally) to 50Gy total dose, 2 Gy single dose, 5 fractions per week, daily IGRT with in-room CT (Tomotherapy)
Tumor resection after 4-6 weeks
Stratum C: Interstitial Brachytherapy to tumor bed with 15 Gy total dose, 3 Gy single dose b.i.d. in second week after tumor resection
| Study group | Role | What they receive |
|---|---|---|
| 1 Arm | Experimental | Stratum A:
R0, primary wound closure
Stratum B:
R0, secondary wound closure
Stratum C:
R1, tertiary wound closure Receives: Radiation: IMRT/IGRT, Tumor resection, Brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Complication Rate
Wound Complication Rate up to 3 months after tumor resection
Measured: 3 months
Secondary outcomes (5)
Efficacy
Efficacy:
Rate of margin-free resection Local control rate (LC) Metastasis-Free Survival (MFS) Disease-Free Survival (DFS) Disease-Specific Survival, Overall Survival (OS) Limb Preservation Rate (LP)
Measured: 2 years
Safety
Acute toxicity as measured by CTCAE v. 4.03 Late toxicity (skin, soft tissue, joint, bone, neural toxicity) as measured by CTCAE v. 4.03
Measured: 2 years
Limb Functionality
as measured by the Musculoskeletal Tumor Society (MSTS) rating scale and the Toronto Extremity Salvage Score (TESS)
Measured: 2 years
Quality of Life
as measured by QLQ C30
Measured: 2 years
Translational
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2012 (estimated)
- Study startAug 2011
- Primary completionJun 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Soft Tissue Sarcoma of the LimbStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barbara Röper, MD, Principal investigator, Klinik für Strahlentherapie und Radiologische Onkologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01552239
- Sponsor's protocol ID
- PRE-1205-ROE-0050-I
- Other IDs
- No. 2009.906.1
- Acronym
- PREMISS
- Status last verified
- Oct 2018
- First submitted
- 26 Jul 2011
- Last updated
- 16 Oct 2018
- Results posted
- No
Publications
Roper B, Heinrich C, Kehl V, Rechl H, Specht K, Wortler K, Topfer A, Molls M, Kampfer S, von Eisenharth-Rothe R, Combs SE. Study of Preoperative Radiotherapy for Sarcomas of the Extremities with Intensity-Modulation, Image-Guidance and Small Safety-margins (PREMISS). BMC Cancer. 2015 Nov 16;15:904. doi: 10.1186/s12885-015-1633-y.
PubMed 26573139
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Preoperative Radiotherapy for Sarcomas of the Extremities With Intensity-Modulation, Image-Guidance, Small Safety-margins and Brachytherapy Conditioned by Resection Margin
- ClinicalTrials.gov ID
- NCT01552239
- Acronym / sponsor ID
- PREMISS / PRE-1205-ROE-0050-I
- Keywords
- Soft tissue sarcoma, Intensity-Modulated Radiation Therapy (IMRT), Tomotherapy, Safety Margins, Image-guided Radiation Therapy, Brachytherapy, interstitial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 13 Mar 2012 (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.
RATIONALE: Modern radiotherapy techniques in a neoadjuvant setting have the potential to minimize morbidity and maximize efficacy. An additional boost dose can be provided locally by HDR-brachytherapy in patients with positive margins after tumor resection.
PURPOSE: This phase II trial is studying the safety and efficacy of a combination of modern radiotherapy elements applied to the tumor and small volumes of surrounding normal tissue (IMRT, IGRT; brachytherapy in case of positive resection margin) and see how well it works in treating patients with High-Risk Soft Tissue Sarcoma of the Extremities.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 Arm | Experimental | Radiation: IMRT/IGRT, Tumor resection, BrachytherapyStratum A: R0, primary wound closure Stratum B: R0, secondary wound closure Stratum C: R1, tertiary wound closure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologic and radiographic proof of localized high-risk soft tissue sarcoma meeting the following criteria:
- Lesion originates in extremity
- AJCC Stage II or III disease (except T1a-tumors or N1)
- Primary presentation or local recurrence
- after biopsy or inadequate surgery resulting in residual tumor in cross-sectional imaging
Key exclusion criteria (17 listed)
- Diagnosis of the following:
- Regional nodal disease or unequivocal distant metastasis
- Life expectancy < 1 year
- Pregnancy
- Major medical illness that would preclude study treatment
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 |
|---|---|---|
| IMRT/IGRT, Tumor resection, BrachytherapyAll: Preoperative IMRT with small safety margins (GTV according to MRT plus 1.5cm laterally / 3cm proximodistally) to 50Gy total dose, 2 Gy single dose, 5 fractions per week, daily IGRT with in-room CT (Tomotherapy) Tumor resection after 4-6 weeks Stratum C: Interstitial Brachytherapy to tumor bed with 15 Gy total dose, 3 Gy single dose b.i.d. in second week after tumor resection | Radiation | 1 Arm |
Primary outcome
Wound Complication Rate
Time frame: 3 months
Wound Complication Rate up to 3 months after tumor resection
5 secondary outcomes
Efficacy
Time frame: 2 years
Safety
Time frame: 2 years
Limb Functionality
Time frame: 2 years
Quality of Life
Time frame: 2 years
Translational
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
- Derived from this study: PubMed 26573139Roper B, Heinrich C, Kehl V, Rechl H, Specht K, Wortler K, Topfer A, Molls M, Kampfer S, von Eisenharth-Rothe R, Combs SE. Study of Preoperative Radiotherapy for Sarcomas of the Extremities with Intensity-Modulation, Image-Guidance and Small Safety-margins (PREMISS). BMC Cancer. 2015 Nov 16;15:904. doi: 10.1186/s12885-015-1633-y.
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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.
Barbara Röper, MD principal investigator
Klinik für Strahlentherapie und Radiologische Onkologie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IMRT/IGRT, Tumor resection, Brachytherapy in people with Soft Tissue Sarcoma of the Limb and AJCC Stage II and III, run by Technical University of Munich at 1 site in Germany.
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 10 inclusion and 17 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 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 Barbara Röper, MD (+49-89-4140 ext. 4509, barbara.roeper@lrz.tu-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Complication Rate (time frame: 3 months). 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 NCT01552239, which also lists 1 linked publication.
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 16 Oct 2018.