DOREMY: Dose Reduction of Preoperative Radiotherapy in Myxoid Liposarcomas

• Sponsor: The Netherlands Cancer Institute (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02106312
• Collaborator: (none)
• Enrollment: 80
• Locations: 12
• Arm: 1
• Anticipated Duration (Months): 132
• Patients Per Site: 6.7
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myxoid Liposarcoma of Soft Tissue	Radiation: dose reduction of preoperative radiotherapy in MLS	Phase 2

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

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Dose Reduction of Preoperative Radiotherapy in Myxoid Liposarcomas
• Actual Study Start Date: Dec 15, 2010
• Anticipated Primary Completion Date: Dec 15, 2021
• Anticipated Study Completion Date: Dec 15, 2021

Arms and Interventions

Arm

Intervention/Treatment

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

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.

Outcome Measures

Primary Outcome Measures

1. 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) [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.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	MA 02215
2	Harvard Cancer Center	Boston	Massachusetts	United States	MA 02215
3	University Hospital Aarhus	Aarhus		Denmark	8000
4	The Netherlands Cancer Institute	Amsterdam	Noord Holland	Netherlands	1066CX
5	Academisch Medisch centrum	Amsterdam		Netherlands	1105 AZ
6	Universitair Medisch Centrum Groningen	Groningen		Netherlands	9713 GZ
7	Leids Universitair Medisch Centrum	Leiden		Netherlands	2333ZA
8	Maastro Clinic	Maastricht		Netherlands	6229 ET
9	Radboud umc	NIjmegen		Netherlands	6225GA
10	Haukeland University Hospital	Bergen		Norway	5021
11	Oslo University Hospital	Oslo		Norway	N-310
12	Royal Marsden Hospital	London		United Kingdom	SW3 6JJ

Sponsors and Collaborators

• The Netherlands Cancer Institute

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Netherlands Cancer Institute
• ClinicalTrials.gov Identifier: NCT02106312
• Other Study ID Numbers: N10DMY; 2588
• First Posted: Apr 8, 2014
• Last Update Posted: Aug 4, 2021
• Last Verified: Jun 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by The Netherlands Cancer Institute: Radiotherapy; Myxoid liposarcoma; Soft tissue sarcoma
• Additional relevant MeSH terms: Liposarcoma; Liposarcoma, Myxoid

Study Results

No Results Posted as of Aug 4, 2021