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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01841047

Acronym

TOMOREP

Enrollment

Registered

2013-04-26

Start date

2009-01-20

Completion date

2018-12-19

Last updated

2025-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liposarcoma

Keywords

Retroperitoneal liposarcoma operable

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.

Interventions

RADIATIONRadiotherapy

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Cumulative Incidence Rate of Local Recurrence and Competing Risks (All Patients)	3 years from start of the tomotherapy treatment	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)	3 years from start of the tomotherapy treatment	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)	3 years from start of the tomotherapy treatment	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

Measure	Time frame	Description
Percentage of Participants With Disease-Free Survival (All Patients)	3 years from start of the tomotherapy treatment	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)	1 year, 3 years and 5 years from start of the tomotherapy treatment	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).
Percentage of Participants With Disease-Free Survival (Liposarcoma Well Differentiated)	3 years from start of the tomotherapy treatment	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)	3 years from start of the tomotherapy treatment	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).

Countries

France

Participant flow

Recruitment details

3 recruitment centers : * Institut Bergonié - Bordeaux * Claudius Régaud - Toulouse * René Gauducheau - Nantes

Participants by arm

Arm	Count
Radiotherapy Evaluation of the combination of radiotherapy with helical tomotherapy (54 Gy) followed by surgery in retro-peritoneal liposarcomas. 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	48
Total	48

Baseline characteristics

Characteristic	Radiotherapy
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	19 Participants
Age, Categorical Between 18 and 65 years	29 Participants
Age, Continuous	63.1 years
Histotype Liposarcoma dedifferentiated or pleomorphic	28 Participants
Histotype Liposarcoma well differentiated	20 Participants
Region of Enrollment France	48 participants
Sex: Female, Male Female	22 Participants
Sex: Female, Male Male	26 Participants
WHO status 0	31 Participants
WHO status 1	13 Participants
WHO status 2	2 Participants
WHO status 3	1 Participants
WHO status 4	0 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	13 / 48
other Total, other adverse events	0 / 0
serious Total, serious adverse events	30 / 48

Outcome results

Primary

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.