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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Liposarcoma

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Trial Information

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


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.


Inclusion Criteria:



1. Liposarcoma histologically proven, in case of non-biopsy contributive: diagnosis
radiologically validated meeting multidisciplinary consultation (RCP)

2. Protocol TOMOREP technically feasible,

3. Patients over 18 years

4. Considered a priori tumor operable even with excision multi-visceral

5. Absence of morbidity against-indicating surgery necessary

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 scheme.

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. Cons-indication for radiotherapy (such as prior radiotherapy the volume to be
treated).

6. Patient included in another clinical study

7. Unable to undergo medical monitoring test for geographical, social or psychological,

8. Private patient freedom and major subject of a measure of legal protection or unable
to consent.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

disease-free survival 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.

Outcome Description:

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. The effectiveness will be evaluated in terms of disease-free survival Local 3 years

Outcome Time Frame:

08/2013 (3 years)

Safety Issue:

No

Principal Investigator

KANTOR Guy, PU-PH

Investigator Role:

Study Chair

Investigator Affiliation:

Institut Bergonié

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

IB2008-42

NCT ID:

NCT01841047

Start Date:

January 2009

Completion Date:

December 2019

Related Keywords:

  • Liposarcoma
  • Retroperitoneal liposarcoma operable
  • Liposarcoma
  • Retroperitoneal Neoplasms

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