To study the feasibility of reducing the dose of preoperative radiotherapy in MLS from 50Gy to 36Gy while maintaining comparable clinicopathological responses.
ID
Source
Brief title
Condition
- Connective tissue disorders (excl congenital)
- Soft tissue neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The induction of a pathological response after reduced RT dose
Secondary outcome
NA
Background summary
To study the feasibility of reducing the dose of preoperative radiotherapy in
MLS from 50Gy to 36Gy while maintaining comparable clinicopathological
responses.
Study objective
To study the feasibility of reducing the dose of preoperative radiotherapy in
MLS from 50Gy to 36Gy while maintaining comparable clinicopathological
responses.
Study design
phase II
Intervention
RT, 36 Gy in 18 fractions.
Study burden and risks
Burden:Repeat biopsy and extra MRI
benefit: reduced toxicity
Plesmanlaan 121 AMSTERDAM
AMSTERDAM 1066 CX
NL
Plesmanlaan 121 AMSTERDAM
AMSTERDAM 1066 CX
NL
Listed location countries
Age
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 (regiment 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.
3. ECOG PS 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 derivatives), coumarines (Sintrom ® and Marcoumar ®), all heparin and heparin-like formulations. (Note: this exclusion criterion only applies for patients on consenting to the translational research part of the study; patient 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL33144.031.10 |
| OMON | NL-OMON23428 |