Trial record 4 of 74 for:    "Liposarcoma"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Institut Bergonié
Sponsor:
Information provided by (Responsible Party):
Institut Bergonié
ClinicalTrials.gov Identifier:
NCT01841047
First received: November 5, 2012
Last updated: April 23, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
Liposarcoma
Radiation: Radiotherapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessment of Helical Tomotherapy Radiotherapy (54 Gy) Followed by Surgery in Retro-peritoneal Liposarcoma

Further study details as provided by Institut Bergonié:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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:
  • Evaluation of the toxicity of the combination radio-surgical [ Time Frame: 08/2013 (1, 3, 5 years) ] [ Designated as safety issue: No ]

    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


Estimated Enrollment: 44
Study Start Date: January 2009
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01841047

Contacts
Contact: KANTOR Guy, PU-PH g.kantor@bordeaux.unicancer.fr
Contact: MATHOULIN PELISSIER Simone, PU-PH s.mathoulin@bordeaux.unicancer.fr

Locations
France
Centre Paul Strauss Recruiting
Strasbourg, Alsace, France, 67000
Contact: NOEL Georges, PU-PH         
Principal Investigator: NOEL Georges, PU-PH         
Institut Bergonié Recruiting
Bordeaux, Aquitaine, France, 33000
Contact: KANTOR Guy, PU-PH       g.kantor@bordeaux.unicancer.fr   
Principal Investigator: KANTOR Guy, PU-PH         
Institut Curie Recruiting
Paris, Ile de France, France, 75000
Contact: ALAPETITE Claire, MD         
Principal Investigator: ALAPETITE Claire, MD         
Centre Claudius Regaud Recruiting
Toulouse, Midi-Pyrénées, France, 31000
Contact: DELANNES Martine, MD         
Principal Investigator: DELANNES Martine, MD         
Centre René Gauducheau Recruiting
Nantes, Pays de la Loire, France, 44000
Contact: MAHE Marc André, PU-PH         
Principal Investigator: MAHE Marc André, PU-PH         
Sponsors and Collaborators
Institut Bergonié
Investigators
Study Chair: KANTOR Guy, PU-PH Institut Bergonié
  More Information

Additional Information:
No publications provided

Responsible Party: Institut Bergonié
ClinicalTrials.gov Identifier: NCT01841047     History of Changes
Other Study ID Numbers: IB2008-42
Study First Received: November 5, 2012
Last Updated: April 23, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut Bergonié:
Retroperitoneal liposarcoma operable

Additional relevant MeSH terms:
Liposarcoma
Retroperitoneal Neoplasms
Neoplasms, Adipose Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Abdominal Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on July 22, 2014