International Prospective Registry on Local Treatment Approaches in MLS

Netherlands Cancer Institute (NKI)

Status: Enrolling

Conditions: Myxoid Liposarcoma

Treatments: Radiation: Postoperative RT 50-66Gy; Radiation: Preoperative RT 36Gy; Radiation: Preoperative RT 50Gy; Radiation: RT 36Gy; Procedure: Surgery

Study type: Observational

Funder types: Other

Identifiers

NCT04699292

M20DMY

IRBd20-354 (Other Identifier)

Details and patient eligibility

About

To prospectively study commonly used local treatment approaches in Myxoid Liposarcoma (MLS)

Full description

In order to confirm the promising results of the 36 Gy dose level in the DOREMY trial (NCT02106312) and to compare outcome with other local treatment approaches.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18 years
• Biopsy proven MLS, including the reciprocal chromosomal translocation t(12;16)(q13;p11)
• ECOG PS 0-2
• Written informed consent to share coded information in this international Registry

Exclusion criteria

• Prior radiotherapy to the target area
• Pregnancy

Trial design

300 participants in 5 patient groups

Cohort A

Description:

MLS patients managed by surgery only

Treatment:

Procedure: Surgery

Cohort B

Description:

MLS patients receiving preoperative RT to a dose of 36 Gy (equivalent) followed by surgery

Treatment:

Radiation: Preoperative RT 36Gy

Procedure: Surgery

Cohort C

Description:

MLS patients receiving preoperative RT to a dose of 50 Gy (equivalent) followed by surgery

Treatment:

Radiation: Preoperative RT 50Gy

Procedure: Surgery

Cohort D

Description:

MLS patients receiving surgery followed by postoperative RT to a dose of 50-66 Gy (equivalent)

Treatment:

Radiation: Postoperative RT 50-66Gy

Procedure: Surgery

Cohort E

Description:

MLS patients with oligometastatic and/or oligoprogressive disease receiving definitive RT to a dose of 36Gy (equivalent)

Treatment:

Radiation: RT 36Gy