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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

Brief Summary:

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.


Detailed Summary:

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.

Sponsor: Institut Bergonié

Current Primary Outcome: 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. [ Time Frame: 08/2013 (3 years) ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome: Evaluation of the toxicity of the combination radio-surgical [ Time Frame: 08/2013 (1, 3, 5 years) ]

Evaluation of the toxicity of the combination radio-surgical

  • Assessment of local recurrence-free survival at 1 year and 5 years
  • Evaluation of overall survival at 1, 3 and 5 years,
  • Description of the technical feasibility of the association radiosurgery, in terms of compliance with the prescribed dose of dose constraints modulated conformal radiotherapy intensity


Original Secondary Outcome: Same as current

Information By: Institut Bergonié

Dates:
Date Received: November 5, 2012
Date Started: January 2009
Date Completion: December 2019
Last Updated: May 24, 2016
Last Verified: May 2016