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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-20

Study Completion Date

2018-12-19

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Liposarcoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Radiotherapy

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

Group Type OTHER

Radiotherapy

Intervention Type RADIATION

Evaluation of the efficacy of the combination with radio-surgery helical tomotherapy irradiation to a dose of radiation of 54 Gy in patients with retroperitoneal liposarcoma of operable

Interventions

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Radiotherapy

Evaluation of the efficacy of the combination with radio-surgery helical tomotherapy irradiation to a dose of radiation of 54 Gy in patients with retroperitoneal liposarcoma of operable

Intervention Type RADIATION

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No