Dose Reduction of Preoperative Radiotherapy in Myxoid Liposarcomas (DOREMY)

• ClinicalTrials.gov Identifier: NCT02106312
• Recruitment Status: Unknown
• First Posted: April 8, 2014
• Last Update Posted: August 4, 2021
• Sponsor: The Netherlands Cancer Institute
• Information provided by (Responsible Party): The Netherlands Cancer Institute

Tracking Information

• First Submitted Date: March 6, 2014
• First Posted Date: April 8, 2014
• Last Update Posted Date: August 4, 2021
• Actual Study Start Date: December 15, 2010
• Estimated Primary Completion Date: December 15, 2021 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 26, 2017): 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. ]
• Original Primary Outcome Measures (submitted: April 3, 2014): The Pathological description of the percentage necrosis 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 necrosis 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. ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Dose Reduction of Preoperative Radiotherapy in Myxoid Liposarcomas
• Official Title: Dose Reduction of Preoperative Radiotherapy in Myxoid Liposarcomas
• Brief 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.

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 Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Myxoid Liposarcoma of Soft Tissue

Intervention

Radiation: 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.

Study Arms

Radiation

Dose reduction of preoperative radiotherapy in MLS from 50 Gy to 36 GY.

Intervention: Radiation: dose reduction of preoperative radiotherapy in MLS

• Publications *: 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: September 26, 2017): 80
• Original Estimated Enrollment (submitted: April 3, 2014): 20
• Estimated Study Completion Date: December 15, 2021
• Estimated Primary Completion Date: December 15, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Age above or equal to 18 years
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:

1. Prior radiotherapy to the target area.
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 -

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Netherlands, Denmark, Norway, United Kingdom, United States

Administrative Information

• NCT Number: NCT02106312
• Other Study ID Numbers: N10DMY; 2588 ( Other Identifier: Nederlands trial register )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: The Netherlands Cancer Institute
• Original Responsible Party: Same as current
• Current Study Sponsor: The Netherlands Cancer Institute
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Rick Haas, MD,PhD; The Netherlands Cancer Institute

• PRS Account: The Netherlands Cancer Institute
• Verification Date: June 2020