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

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ClinicalTrials.gov Identifier: NCT01841047
Recruitment Status : Active, not recruiting
First Posted : April 26, 2013
Last Update Posted : October 2, 2017
Sponsor:
Information provided by (Responsible Party):
Institut Bergonié

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.


Condition or disease Intervention/treatment Phase
Liposarcoma Radiation: Radiotherapy Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of Helical Tomotherapy Radiotherapy (54 Gy) Followed by Surgery in Retro-peritoneal Liposarcoma
Study Start Date : January 2009
Actual Primary Completion Date : September 2013
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Radiotherapy
Evaluation of the combination of radiotherapy with tomotherapy coil (54 Gy) followed by surgery in liposarcomas retroperitoneal.
Radiation: 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 Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01841047


Locations
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France
Centre Paul Strauss
Strasbourg, Alsace, France, 67000
Institut Bergonié
Bordeaux, Aquitaine, France, 33000
Institut Curie
Paris, Ile de France, France, 75000
Centre Claudius Regaud
Toulouse, Midi-Pyrénées, France, 31000
Centre René Gauducheau
Nantes, Pays de la Loire, France, 44000
Sponsors and Collaborators
Institut Bergonié
Investigators
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Study Chair: KANTOR Guy, PU-PH Institut Bergonié

Additional Information:
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Responsible Party: Institut Bergonié
ClinicalTrials.gov Identifier: NCT01841047     History of Changes
Other Study ID Numbers: IB2008-42
First Posted: April 26, 2013    Key Record Dates
Last Update Posted: October 2, 2017
Last Verified: September 2017
Keywords provided by Institut Bergonié:
Retroperitoneal liposarcoma operable
Additional relevant MeSH terms:
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Liposarcoma
Neoplasms, Adipose Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma