Myxoid Liposarcoma of Soft TissuePhase 2DOREMYNCT02106312
Dose Reduction of Preoperative Radiotherapy in Myxoid Liposarcomas
A Phase 2 study testing dose reduction of preoperative radiotherapy in MLS in people with Myxoid Liposarcoma of Soft Tissue, run by The Netherlands Cancer Institute at 12 sites in 5 countries.
Trial summary
To study the feasibility of reducing the dose of preoperative radiotherapy in MLS (Myxoid Liposarcomas) from 50 Gy to 36 Gy while maintaining comparable clinicopathological responses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myxoid Liposarcoma of Soft Tissue
- What is being tested?
- dose reduction of preoperative radiotherapy in MLS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 12 sitesin 5 countries
- Study dates
- 15 Dec 2010to 15 Dec 2021
- 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
- Age above or equal to 18 years
- Biopsy proven MLS (including the reciprocal chromosomal translocation t(12;16)(q13;p11); A the primary sarcoma in case of non-metastatic disease for management is with curative intent (regimen to be chosen = 18 x 2 GY) B in case of oligometastatic patients, the metastasis may also be irradiated to a dose of 36 GY in order to postpone the time interval to next systemic chemotherapy. These patients are usually not operated upon and the total dose may also be reached in 12 times 3 Gy, for convenience purposes (see paragraph 10 for radiobiological considerations).
- ECOG (Eastern Cooperative Oncology Group) PS (Performance Status) 0-2
- Patients must be able (physically, mentally and socially) to complete a series of RT, followed by an observation period of 4-6 weeks and undergo surgery.
- Written informed consent
Who cannot join
- Prior radiotherapy to the target area.
- Anticoagulant medication of any kind; especially Ascal®(and derivates), coumarines (Sintrom® and Marcoumar®), all heparin and heparin-like formulations. (Note: this exclusion criterion only applies for patients consenting to the translational research part of the study; patients on anticoagulant medication as described above may take part in the dose reduction part of the study, but the repeat biopsies may not be taken.)
- Pregnancy -
Trial locations and contacts
12 sites in 5 countries.
12 sites in 5 countries
Netherlands6 sites
The Netherlands Cancer Institute
Amsterdam, North Holland, 1066CX
Academisch Medisch centrum
Amsterdam, 1105 AZ
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ
Leids Universitair Medisch Centrum
Leiden, 2333ZA
Maastro Clinic
Maastricht, 6229 ET
Radboud umc
Nijmegen, 6225GA
United States2 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, MA 02215
Harvard Cancer Center
Boston, Massachusetts, MA 02215
Norway2 sites
Haukeland University Hospital
Bergen, 5021
Oslo University Hospital
Oslo, N-310
About this study
To study the feasibility of reducing the dose of preoperative radiotherapy in MLS (Myxoid Liposarcomas) from 50 Gy to 36 Gy while maintaining comparable clinicopathological responses.
Read the detailed description
- A Bayesian approach is considered for the analysis of this trial. The aim is to provide a stopping rule for inefficacy of the new dose.
- Two aspects are important to elucidate the mechanism of this treatment: dynamic investigations of perfusion and vasculature. Apart from participation to the dose reduction paragraphs of this study, patients will be also asked to undergo, at clinically relevant dose points, dynamic contrast enhanced (DEC) MRI scans and separately tumor biopsies.
- Conditions
- Myxoid Liposarcoma of Soft Tissue
- Being tested
- dose reduction of preoperative radiotherapy in MLS
- Keywords
- Radiotherapy, Myxoid liposarcoma, Soft tissue sarcoma
- Medical subject headings
- Liposarcoma, Myxoid, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dose reduction of preoperative radiotherapy in MLSRadiation
A: The primary sarcoma in case of non-metastatic disease for management is with curative intent (regime to be chosen=18 x 2 Gy) B: In case of oligometastatic patients, the metastasis may also be irradiated to a dose of 36 Gy in order to postpone the time interval to next systemic chemotherapy. These patients are usually not operated upon and the total dose may also be reached in 12 times 3 Gy, for convenience purposes.
| Study group | Role | What they receive |
|---|---|---|
| Radiation | Other | Dose reduction of preoperative radiotherapy in MLS from 50 Gy to 36 GY. Receives: Radiation: dose reduction of preoperative radiotherapy in MLS |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Pathological description of the percentage pathological responses after reduced RT (radiotherapy) dose from (conventionally) 25 x 2 Gy to 18 x 2 Gy (in the current study)
Measured: The percentage of pathological responses will be pathologically assessed on the resection specimen; this procedure will take on average 7-10 working days. After surgery, patients will be followed up to 10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study start15 Dec 2010
- Primary completion15 Dec 2021 (estimated)
- Study completion15 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myxoid Liposarcoma of Soft TissueStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rick Haas, MD,PhD, Principal investigator, The Netherlands Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02106312
- Sponsor's protocol ID
- N10DMY
- Other IDs
- 2588
- Acronym
- DOREMY
- Status last verified
- Jun 2020
- First submitted
- 6 Mar 2014
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lansu J, Bovee JVMG, Braam PM, Miah AB, Bruland OS, Baldini EH, Scholten AN, Hamming-Vrieze O, Heukelom J, Wiltink LM, Foppele F, Ubbels JF, van der Noort V, Haas RL. Dose Reduction of Preoperative Radiotherapy in Myxoid Liposarcoma: The Phase 2 DOREMY Nonrandomized Clinical Trial. JAMA Oncol. 2026 May 16:e261577. doi: 10.1001/jamaoncol.2026.1577. Online ahead of print.
PubMed 42141895Lansu J, Bovee JVMG, Braam P, van Boven H, Flucke U, Bonenkamp JJ, Miah AB, Zaidi SH, Thway K, Bruland OS, Baldini EH, Jebsen NL, Scholten AN, van den Ende PLA, Krol ADG, Ubbels JF, van der Hage JA, van Werkhoven E, Klomp HM, van der Graaf WTA, van Coevorden F, Schrage Y, van Houdt WJ, Haas RL. Dose Reduction of Preoperative Radiotherapy in Myxoid Liposarcoma: A Nonrandomized Controlled Trial. JAMA Oncol. 2021 Jan 1;7(1):e205865. doi: 10.1001/jamaoncol.2020.5865. Epub 2021 Jan 21.
PubMed 33180100
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Reduction of Preoperative Radiotherapy in Myxoid Liposarcomas
- ClinicalTrials.gov ID
- NCT02106312
- Acronym / sponsor ID
- DOREMY / N10DMY
- Conditions
- Myxoid Liposarcoma of Soft Tissue
- Keywords
- Radiotherapy, Myxoid liposarcoma, Soft tissue sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Study start
- 15 Dec 2010 (actual)
- Primary completion
- 15 Dec 2021 (estimated)
- Study completion
- 15 Dec 2021 (estimated)
- First posted
- 8 Apr 2014 (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.
To study the feasibility of reducing the dose of preoperative radiotherapy in MLS (Myxoid Liposarcomas) from 50 Gy to 36 Gy while maintaining comparable clinicopathological responses.
Detailed description
- A Bayesian approach is considered for the analysis of this trial. The aim is to provide a stopping rule for inefficacy of the new dose.
- Two aspects are important to elucidate the mechanism of this treatment: dynamic investigations of perfusion and vasculature. Apart from participation to the dose reduction paragraphs of this study, patients will be also asked to undergo, at clinically relevant dose points, dynamic contrast enhanced (DEC) MRI scans and separately tumor biopsies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation | Other | Radiation: dose reduction of preoperative radiotherapy in MLSDose reduction of preoperative radiotherapy in MLS from 50 Gy to 36 GY. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age above or equal to 18 years
- Biopsy proven MLS (including the reciprocal chromosomal translocation t(12;16)(q13;p11); A the primary sarcoma in case of non-metastatic disease for management is with curative intent (regimen to be chosen = 18 x 2 GY) B in case of oligometastatic patients, the metastasis may also be irradiated to a dose of 36 GY in order to postpone the time interval to next systemic chemotherapy. These patients are usually not operated upon and the total dose may also be reached in 12 times 3 Gy, for convenience purposes (see paragraph 10 for radiobiological considerations).
- ECOG (Eastern Cooperative Oncology Group) PS (Performance Status) 0-2
- Patients must be able (physically, mentally and socially) to complete a series of RT, followed by an observation period of 4-6 weeks and undergo surgery.
- Written informed consent
Key exclusion criteria (3 listed)
- Prior radiotherapy to the target area.
- Anticoagulant medication of any kind; especially Ascal®(and derivates), coumarines (Sintrom® and Marcoumar®), all heparin and heparin-like formulations. (Note: this exclusion criterion only applies for patients consenting to the translational research part of the study; patients on anticoagulant medication as described above may take part in the dose reduction part of the study, but the repeat biopsies may not be taken.)
- Pregnancy -
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 |
|---|---|---|
| dose reduction of preoperative radiotherapy in MLSA: The primary sarcoma in case of non-metastatic disease for management is with curative intent (regime to be chosen=18 x 2 Gy) B: In case of oligometastatic patients, the metastasis may also be irradiated to a dose of 36 Gy in order to postpone the time interval to next systemic chemotherapy. These patients are usually not operated upon and the total dose may also be reached in 12 times 3 Gy, for convenience purposes. | Radiation | Radiation |
Primary outcome
The Pathological description of the percentage pathological responses after reduced RT (radiotherapy) dose from (conventionally) 25 x 2 Gy to 18 x 2 Gy (in the current study)
Time frame: The percentage of pathological responses will be pathologically assessed on the resection specimen; this procedure will take on average 7-10 working days. After surgery, patients will be followed up to 10 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Derived from this study: PubMed 42141895Lansu J, Bovee JVMG, Braam PM, Miah AB, Bruland OS, Baldini EH, Scholten AN, Hamming-Vrieze O, Heukelom J, Wiltink LM, Foppele F, Ubbels JF, van der Noort V, Haas RL. Dose Reduction of Preoperative Radiotherapy in Myxoid Liposarcoma: The Phase 2 DOREMY Nonrandomized Clinical Trial. JAMA Oncol. 2026 May 16:e261577. doi: 10.1001/jamaoncol.2026.1577. Online ahead of print.
- Derived from this study: PubMed 33180100Lansu J, Bovee JVMG, Braam P, van Boven H, Flucke U, Bonenkamp JJ, Miah AB, Zaidi SH, Thway K, Bruland OS, Baldini EH, Jebsen NL, Scholten AN, van den Ende PLA, Krol ADG, Ubbels JF, van der Hage JA, van Werkhoven E, Klomp HM, van der Graaf WTA, van Coevorden F, Schrage Y, van Houdt WJ, Haas RL. Dose Reduction of Preoperative Radiotherapy in Myxoid Liposarcoma: A Nonrandomized Controlled Trial. JAMA Oncol. 2021 Jan 1;7(1):e205865. doi: 10.1001/jamaoncol.2020.5865. Epub 2021 Jan 21.
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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.
Rick Haas, MD,PhD principal investigator
The Netherlands Cancer Institute
12 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing dose reduction of preoperative radiotherapy in MLS in people with Myxoid Liposarcoma of Soft Tissue, run by The Netherlands Cancer Institute at 12 sites in 5 countries.
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 5 inclusion and 3 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 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Netherlands, United States, Norway, Denmark, United Kingdom. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Pathological description of the percentage pathological responses after reduced RT (radiotherapy) dose from (conventionally) 25 x 2 Gy to 18 x 2 Gy (in the current study) (time frame: The percentage of pathological responses will be pathologically assessed on the resection specimen; this procedure will take on average 7-10 working days. After surgery, patients will be followed up to 10 years.). 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 NCT02106312, which also lists 2 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 4 Aug 2021.