Dose Reduction of Preoperative Radiotherapy in Myxoid Liposarcomas
NCT ID: NCT02106312
Last Updated: 2021-08-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
80 participants
INTERVENTIONAL
2010-12-15
2021-12-15
Brief Summary
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Detailed Description
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* 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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Radiation
Dose reduction of preoperative radiotherapy in MLS from 50 Gy to 36 GY.
dose reduction of preoperative radiotherapy in MLS
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.
Interventions
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dose reduction of preoperative radiotherapy in MLS
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.
Eligibility Criteria
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Inclusion Criteria
2. 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).
3. ECOG (Eastern Cooperative Oncology Group) PS (Performance Status) 0-2
4. 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.
5. Written informed consent
Exclusion Criteria
2. 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.)
3. Pregnancy -
18 Years
ALL
No
Sponsors
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The Netherlands Cancer Institute
OTHER
Responsible Party
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Principal Investigators
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Rick Haas, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
The Netherlands Cancer Institute
Locations
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Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Harvard Cancer Center
Boston, Massachusetts, United States
University Hospital Aarhus
Aarhus, , Denmark
The Netherlands Cancer Institute
Amsterdam, North Holland, Netherlands
Academisch Medisch centrum
Amsterdam, , Netherlands
Universitair Medisch Centrum Groningen
Groningen, , Netherlands
Leids Universitair Medisch Centrum
Leiden, , Netherlands
Maastro Clinic
Maastricht, , Netherlands
Radboud umc
Nijmegen, , Netherlands
Haukeland University Hospital
Bergen, , Norway
Oslo University Hospital
Oslo, , Norway
Royal Marsden Hospital
London, , United Kingdom
Countries
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References
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Lansu 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.
Other Identifiers
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2588
Identifier Type: OTHER
Identifier Source: secondary_id
N10DMY
Identifier Type: -
Identifier Source: org_study_id
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