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

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.

Study Overview

• Status: Completed
• Conditions: Liposarcoma
• Intervention / Treatment: Radiation: Radiotherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Alsace
    • Strasbourg, Alsace, France, 67000
      • Centre Paul Strauss
  • Aquitaine
    • Bordeaux, Aquitaine, France, 33000
      • Institut Bergonie
  • Ile De France
    • Paris, Ile De France, France, 75000
      • Institut Curie
  • Midi-Pyrénées
    • Toulouse, Midi-Pyrénées, France, 31000
      • Centre Claudius Régaud
  • Pays De La Loire
    • Nantes, Pays De La Loire, France, 44000
      • Centre Rene Gauducheau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Liposarcoma histologically proven, in case of non-contributive biopsy: diagnosis radiologically validated within a multidisciplinary meeting
2. Protocol TOMOREP technically feasible,
3. Patients over 18 years
4. Considered as resectable even if multi-visceral excision is needed
5. 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.
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.

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. Contra-indication to radiotherapy (such as prior radiotherapy into the volume to treat).
6. Patient included in another clinical trial
7. Patient unable to undergo medical monitoring test for any geographical, social or psychological reasons,
8. Private patient freedom and major subject of a measure of legal protection or unable to consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Radiotherapy; Evaluation of the combination of radiotherapy with helical tomotherapy (54 Gy) followed by surgery in retro-peritoneal liposarcomas.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Disease-Free Survival (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 disease free survival rate at 3 years, with the kaplan-meier method. The disease-free survival time is calculated between the date of the start of the tomotherapy treatment and the date of death, distant metastasis or local recurrence (events), whichever occur first, or the date of last news (censorship).	3 years from start of the tomotherapy treatment
Percentage of Participants With Disease-Free Survival (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 disease free survival rate at 3 years, with the kaplan-meier method. The disease-free survival time is calculated between the date of the start of the tomotherapy treatment and the date of death, distant metastasis or local recurrence (events), whichever occur first, or the date of last news (censorship).	3 years from start of the tomotherapy treatment
Percentage of Participants With Disease-Free Survival (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 disease free survival rate at 3 years, with the kaplan-meier method. The disease-free survival time is calculated between the date of the start of the tomotherapy treatment and the date of death, distant metastasis or local recurrence (events), whichever occur first, or the date of last news (censorship).	3 years from start of the tomotherapy treatment
Percentage of Participants With Overall Survival (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 overall survival rate at 1, 3 and 5 years, with the kaplan-meier method. The overall survival time is calculated between the date of the start of the tomotherapy treatment and the date of death (event), or the date of last news (censorship).	1 year, 3 years and 5 years from start of the tomotherapy treatment

Collaborators and Investigators

• Sponsor: Institut Bergonié
• Investigators: Study Chair: KANTOR Guy, PU-PH, Institut Bergonie

Publications and helpful links

Helpful Links

• Site internet du promoteur, l'Institut Bergonié
• Registre des essais cliniques de l'INCa

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2009
• Primary Completion (Actual): June 14, 2016
• Study Completion (Actual): December 19, 2018

Study Registration Dates

• First Submitted: November 5, 2012
• First Submitted That Met QC Criteria: April 23, 2013
• First Posted (Estimate): April 26, 2013

Study Record Updates

• Last Update Posted (Actual): March 16, 2021
• Last Update Submitted That Met QC Criteria: February 22, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Retroperitoneal liposarcoma operable
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Neoplasms, Adipose Tissue; Liposarcoma
• Other Study ID Numbers: IB2008-42

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No