Back to resultsAssessment of Helical Tomotherapy Radiotherapy (54 Gy) Followed by Surgery in Retro-peritoneal Liposarcoma (TOMOREP)
Primary Purpose
Liposarcoma
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Liposarcoma focused on measuring Retroperitoneal liposarcoma operable
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Centre Paul Strauss
- Institut Bergonié
- Institut Curie
- Centre Claudius Regaud
- Centre René Gauducheau
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Radiotherapy
Arm Description
Evaluation of the combination of radiotherapy with helical tomotherapy (54 Gy) followed by surgery in retro-peritoneal liposarcomas.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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).
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).
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).
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01841047
Brief Title
Assessment of Helical Tomotherapy Radiotherapy (54 Gy) Followed by Surgery in Retro-peritoneal Liposarcoma
Acronym
TOMOREP
Official Title
Assessment of Helical Tomotherapy Radiotherapy (54 Gy) Followed by Surgery in Retro-peritoneal Liposarcoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 20, 2009 (Actual)
Primary Completion Date
June 14, 2016 (Actual)
Study Completion Date
December 19, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Bergonié
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liposarcoma
Keywords
Retroperitoneal liposarcoma operable
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Radiotherapy
Arm Type
Other
Arm Description
Evaluation of the combination of radiotherapy with helical tomotherapy (54 Gy) followed by surgery in retro-peritoneal liposarcomas.
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
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 Measure Information:
Title
Cumulative Incidence Rate of Local Recurrence and Competing Risks (All Patients)
Description
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.
Time Frame
3 years from start of the tomotherapy treatment
Title
Cumulative Incidence Rate of Local Recurrence and Competing Risks (Liposarcoma Well Differentiated)
Description
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.
Time Frame
3 years from start of the tomotherapy treatment
Title
Cumulative Incidence Rate of Local Recurrence and Competing Risks (Liposarcoma Dedifferentiated or Pleomorphic)
Description
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.
Time Frame
3 years from start of the tomotherapy treatment
Secondary Outcome Measure Information:
Title
Percentage of Participants With Disease-Free Survival (All Patients)
Description
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).
Time Frame
3 years from start of the tomotherapy treatment
Title
Percentage of Participants With Disease-Free Survival (Liposarcoma Well Differentiated)
Description
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).
Time Frame
3 years from start of the tomotherapy treatment
Title
Percentage of Participants With Disease-Free Survival (Liposarcoma Dedifferentiated or Pleomorphic)
Description
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).
Time Frame
3 years from start of the tomotherapy treatment
Title
Percentage of Participants With Overall Survival (All Patients)
Description
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).
Time Frame
1 year, 3 years and 5 years from start of the tomotherapy treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
KANTOR Guy, PU-PH
Organizational Affiliation
Institut Bergonié
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Paul Strauss
City
Strasbourg
State/Province
Alsace
ZIP/Postal Code
67000
Country
France
Facility Name
Institut Bergonié
City
Bordeaux
State/Province
Aquitaine
ZIP/Postal Code
33000
Country
France
Facility Name
Institut Curie
City
Paris
State/Province
Ile De France
ZIP/Postal Code
75000
Country
France
Facility Name
Centre Claudius Regaud
City
Toulouse
State/Province
Midi-Pyrénées
ZIP/Postal Code
31000
Country
France
Facility Name
Centre René Gauducheau
City
Nantes
State/Province
Pays De La Loire
ZIP/Postal Code
44000
Country
France
12. IPD Sharing Statement
Links:
URL
https://www.e-cancer.fr/Professionnels-de-sante/Le-registre-des-essais-cliniques/Le-registre-des-essais-cliniques
Description
Registre des essais cliniques de l'INCa
URL
https://www.bergonie.fr/les-essais-cliniques/
Description
Site internet du promoteur, l'Institut Bergonié
Learn more about this trial
Assessment of Helical Tomotherapy Radiotherapy (54 Gy) Followed by Surgery in Retro-peritoneal Liposarcoma
We'll reach out to this number within 24 hrs