Overview

This trial is active, not recruiting.

Condition liposarcoma
Treatment radiotherapy
Phase phase 2
Sponsor Institut Bergonié
Start date January 2009
End date September 2013
Trial size 44 participants
Trial identifier NCT01841047, IB2008-42

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Evaluation of the combination of radiotherapy with tomotherapy coil (54 Gy) followed by surgery in liposarcomas retroperitoneal.
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

Primary Outcomes

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.
time frame: 08/2013 (3 years)

Secondary Outcomes

Measure
Evaluation of the toxicity of the combination radio-surgical
time frame: 08/2013 (1, 3, 5 years)

Eligibility Criteria

Male or female participants at least 18 years old.

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. 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 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.

Additional Information

Official title Assessment of Helical Tomotherapy Radiotherapy (54 Gy) Followed by Surgery in Retro-peritoneal Liposarcoma
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Institut Bergonié.