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

NCT01841047 | Completed Results DMC

• 1 other identifier: IB2008-42
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 5

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.

Conditions

Liposarcoma

Keywords

Retroperitoneal liposarcoma operable

Outcome Measures

Primary Outcomes (3)

• Cumulative Incidence Rate of Local Recurrence and Competing Risks (All Patients)

  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 local recurrence-free survival 3 years. Given the data and the lack of independence between local recurrence and metastasis events, the Kaplan Meier method cannot be applied. An estimation method adapted to the presence of competing risks is necessary. Including other events (metastasis, deaths...) consist in using a competing risk analysis methodology where the specific incidence of each type of event is estimated in the presence of the other types of events. The following results represent the cumulative incidence (as a percentage) of local recurrence on the one hand and the cumulative incidence of competing risks (distant metastasis or death) on the other hand.

  3 years from start of the tomotherapy treatment

• Cumulative Incidence Rate of Local Recurrence and Competing Risks (Liposarcoma Well Differentiated)

  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 local recurrence-free survival 3 years.Given the data and the lack of independence between local recurrence and metastasis events, the Kaplan Meier method cannot be applied. An estimation method adapted to the presence of competing risks is necessary. Including other events (metastasis, deaths...) consist in using a competing risk analysis methodology where the specific incidence of each type of event is estimated in the presence of the other types of events. The following results represent the cumulative incidence (as a percentage) of local recurrence on the one hand and the cumulative incidence of competing risks (distant metastasis or death) on the other hand.

  3 years from start of the tomotherapy treatment

• Cumulative Incidence Rate of Local Recurrence and Competing Risks (Liposarcoma Dedifferentiated or Pleomorphic)

  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 local recurrence-free survival 3 years.Given the data and the lack of independence between local recurrence and metastasis events, the Kaplan Meier method cannot be applied. An estimation method adapted to the presence of competing risks is necessary. Including other events (metastasis, deaths...) consist in using a competing risk analysis methodology where the specific incidence of each type of event is estimated in the presence of the other types of events. The following results represent the cumulative incidence (as a percentage) of local recurrence on the one hand and the cumulative incidence of competing risks (distant metastasis or death) on the other hand.

  3 years from start of the tomotherapy treatment

Secondary Outcomes (4)

• Percentage of Participants With Disease-Free Survival (All Patients)

  3 years from start of the tomotherapy treatment

• Percentage of Participants With Disease-Free Survival (Liposarcoma Well Differentiated)

  3 years from start of the tomotherapy treatment

• Percentage of Participants With Disease-Free Survival (Liposarcoma Dedifferentiated or Pleomorphic)

  3 years from start of the tomotherapy treatment

• Percentage of Participants With Overall Survival (All Patients)

  1 year, 3 years and 5 years from start of the tomotherapy treatment

Study Arms (1)

Radiotherapy

OTHER

Evaluation of the combination of radiotherapy with helical tomotherapy (54 Gy) followed by surgery in retro-peritoneal liposarcomas.

Radiation: Radiotherapy

Interventions

Radiotherapy RADIATION

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

Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Liposarcoma histologically proven, in case of non-contributive biopsy: diagnosis radiologically validated within a multidisciplinary meeting
• Protocol TOMOREP technically feasible,
• Patients over 18 years
• Considered as resectable even if multi-visceral excision is needed
• Absence of morbidity contra-indicating surgery. The evaluation will be performed by the surgeon or the radiotherapist according to the definitions by the ASA classification.
• Original form (as well as tumors made after first incomplete excision) and form in first relapse.
• Life expectancy greater than 6 months
• Patient signed informed consent,
• Patient affiliated to a social security.

You may not qualify if:

• Metastasis associated
• Extension intraperitoneal associated, mesenteric extension
• bilaterally
• Against disease-indicating the need for surgery (ASA 3 and 4).
• Contra-indication to radiotherapy (such as prior radiotherapy into the volume to treat).
• Patient included in another clinical trial
• Patient unable to undergo medical monitoring test for any geographical, social or psychological reasons,
• Private patient freedom and major subject of a measure of legal protection or unable to consent.

Sponsors & Collaborators

• Institut Bergonié: lead

Study Sites (5)

Centre Paul Strauss

Strasbourg, Alsace, 67000, France

Location

Institut Bergonié

Bordeaux, Aquitaine, 33000, France

Location

Centre Claudius Regaud

Toulouse, Midi-Pyrénées, 31000, France

Location

Centre René Gauducheau

Nantes, Pays de la Loire Region, 44000, France

Location

Institut Curie

Paris, Île-de-France Region, 75000, France

Location

Related Publications (1)

• Sargos P, Stoeckle E, Ducassou A, Giraud A, Mervoyer A, Italiano A, Albert S, Ferron G, Bellera C, Kantor G. High dose (54 Gy) pre-operative helical tomotherapy for retroperitoneal liposarcoma: Results of a phase II multicenter study. Radiother Oncol. 2023 Sep;186:109791. doi: 10.1016/j.radonc.2023.109791. Epub 2023 Jul 10.

  PMID: 37437608 BACKGROUND

MeSH Terms

Conditions

Liposarcoma

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms, Adipose Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Pr Guy KANTOR
• Organization: Institut Bergonié

G.Kantor@bordeaux.unicancer.fr

Study Officials

• KANTOR Guy, PU-PH

  Institut Bergonié

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2012
• First Posted: April 26, 2013
• Study Start: January 20, 2009
• Primary Completion: June 14, 2016
• Study Completion: December 19, 2018
• Last Updated: September 3, 2025
• Results First Posted: March 16, 2021

Record last verified: 2021-02

Locations

FR (5)