Assessment of Helical Tomotherapy Radiotherapy (54 Gy) Followed by Surgery in Retro-peritoneal Liposarcoma (TOMOREP)

Institut Bergonié

Status: Completed

Conditions: Liposarcoma

Treatments: Radiation: Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01841047

IB2008-42

Details and patient eligibility

About

Retro peritoneal liposarcomas are rare (less than 15% of sarcomas) whose prognosis is locoregional.

In the treatment of retroperitoneal liposarcomas main prognostic factor is the quality of the surgical resection. The effect of radiotherapy combined with surgery is uncertain and until now limited perhaps because of limited prescribed doses (of the order of 45Gy to 50Gy) due to high risk of organ toxicity nearby.

The helical tomotherapy is an innovative equipment radiotherapy to make conformational radiotherapy modulation intensity and is particularly suitable for irradiations precision (imaging mode associated with daily scanner) in large complex volumes. Increasing doses (increase of the prescribed dose to 54 Gy, thus potentially curative), the helical tomotherapy should allow to improve the efficacy of radiotherapy.

Full description

Retro peritoneal liposarcomas are rare (less than 15% of sarcomas) whose prognosis is locoregional. In the treatment of retroperitoneal liposarcomas main prognostic factor is the quality of the surgical resection. The effect of radiotherapy combined with surgery is uncertain and until now limited perhaps because of limited prescribed doses (of the order of 45Gy to 50Gy) due to high risk of organ toxicity nearby.

Two elements can overcome these difficulties:

• Preoperative radiotherapy made rather than Postoperatively, the tumor in place back the gastrointestinal tract and reducing toxicity,
• The contribution of conformal radiotherapy techniques with intensity modulation (IMRT). The helical tomotherapy is an innovative equipment radiotherapy to make conformational radiotherapy modulation intensity and is particularly suitable for irradiations precision (imaging mode associated with daily scanner) in large complex volumes. Increasing doses (increase of the prescribed dose to 54 Gy, thus potentially curative), the helical tomotherapy should allow to improve the efficacy of radiotherapy.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Liposarcoma histologically proven, in case of non-contributive biopsy: diagnosis radiologically validated within a multidisciplinary meeting
2. Protocol TOMOREP technically feasible,
3. Patients over 18 years
4. Considered as resectable even if multi-visceral excision is needed
5. Absence of morbidity contra-indicating surgery. The evaluation will be performed by the surgeon or the radiotherapist according to the definitions by the ASA classification.
6. Original form (as well as tumors made after first incomplete excision) and form in first relapse.
7. Life expectancy greater than 6 months
8. Patient signed informed consent,
9. Patient affiliated to a social security.

Exclusion criteria

1. Metastasis associated
2. Extension intraperitoneal associated, mesenteric extension
3. bilaterally
4. Against disease-indicating the need for surgery (ASA 3 and 4).
5. Contra-indication to radiotherapy (such as prior radiotherapy into the volume to treat).
6. Patient included in another clinical trial
7. Patient unable to undergo medical monitoring test for any geographical, social or psychological reasons,
8. Private patient freedom and major subject of a measure of legal protection or unable to consent.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Radiotherapy

Other group

Description:

Evaluation of the combination of radiotherapy with helical tomotherapy (54 Gy) followed by surgery in retro-peritoneal liposarcomas.

Treatment:

Radiation: Radiotherapy