LiposarcomaTOMOREPNCT01841047

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

A study testing Radiotherapy in people with Liposarcoma, run by Institut Bergonié at 5 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Liposarcoma
What is being tested?: Radiotherapy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 5 sitesFrance
Study dates: 20 Jan 2009to 19 Dec 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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Life expectancy greater than 6 months
Patient signed informed consent,
Patient affiliated to a social security.

Who cannot join

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.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

France5 sites

Institut Bergonié
Bordeaux, Aquitaine, 33000
Centre René Gauducheau
Nantes, Pays de la Loire Region, 44000
Institut Curie
Paris, Île-de-France Region, 75000
Centre Paul Strauss
Strasbourg, Alsace, 67000
Centre Claudius Regaud
Toulouse, Midi-Pyrénées, 31000

Other trials in France

About this study

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.

Read the 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.

Conditions: Liposarcoma
Being tested: Radiotherapy
Keywords: Retroperitoneal liposarcoma operable
Medical subject headings: Liposarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RadiotherapyRadiation
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 groups in NCT01841047
Study group	Role	What they receive
Radiotherapy	Other	Evaluation of the combination of radiotherapy with helical tomotherapy (54 Gy) followed by surgery in retro-peritoneal liposarcomas. Receives: Radiation: Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 3 years from start of the tomotherapy treatment

Secondary outcomes (4)

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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 1 year, 3 years and 5 years from start of the tomotherapy treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jan 200919 Dec 2018

First posted26 Apr 2013 (estimated)
Study start20 Jan 2009
Primary completion14 Jun 2016
Study completion19 Dec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for LiposarcomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01841047
Sponsor's protocol ID: IB2008-42
Acronym: TOMOREP
Status last verified: Feb 2021
First submitted: 5 Nov 2012
Last updated: 3 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 37437608

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Active, not recruitingPhase 2
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RecruitingPhase 1
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Metastatic Dedifferentiated Liposarcoma, Metastatic Leiomyosarcoma
Active, not recruitingPhase 2
Oleclumab and Durvalumab for the Treatment of Recurrent, Refractory, or Metastatic Sarcoma
Metastatic Angiosarcoma, Metastatic Dedifferentiated Liposarcoma
RecruitingPhase 1/2
Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors
Liposarcoma, Prostate Cancer

All Liposarcoma trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of Helical Tomotherapy Radiotherapy (54 Gy) Followed by Surgery in Retro-peritoneal Liposarcoma
ClinicalTrials.gov ID: NCT01841047
Acronym / sponsor ID: TOMOREP / IB2008-42
Conditions: Liposarcoma
Keywords: Retroperitoneal liposarcoma operable
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Institut BergoniéUniversity, hospital or other
Study start: 20 Jan 2009 (actual)
Primary completion: 14 Jun 2016 (actual)
Study completion: 19 Dec 2018 (actual)
First posted: 26 Apr 2013 (estimated)
Results: Posted 16 Mar 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Retro peritoneal liposarcomas are rare (less than 15% of sarcomas) whose prognosis is locoregional.

Detailed description

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 design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Radiotherapy	Other	Radiation: RadiotherapyEvaluation of the combination of radiotherapy with helical tomotherapy (54 Gy) followed by surgery in retro-peritoneal liposarcomas.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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.

Key exclusion criteria (8 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RadiotherapyEvaluation 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	Radiation	Radiotherapy

Primary outcome

Cumulative Incidence Rate of Local Recurrence and Competing Risks (All Patients)
Time frame: 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)
Time frame: 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)
Time frame: 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.

4 secondary outcomes

Percentage of Participants With Disease-Free Survival (All Patients)
Time frame: 3 years from start of the tomotherapy treatment
Percentage of Participants With Disease-Free Survival (Liposarcoma Well Differentiated)
Time frame: 3 years from start of the tomotherapy treatment
Percentage of Participants With Disease-Free Survival (Liposarcoma Dedifferentiated or Pleomorphic)
Time frame: 3 years from start of the tomotherapy treatment
Percentage of Participants With Overall Survival (All Patients)
Time frame: 1 year, 3 years and 5 years from start of the tomotherapy treatment

Results and safety

Results posted to the registry on 16 Mar 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Radiotherapy	48	48

Primary outcome: Cumulative Incidence Rate of Local Recurrence and Competing Risks (All Patients)

Time frame: 3 years from start of the tomotherapy treatment. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Radiotherapy n = 48
Cumulative incidence rate of local recurrence	16.89 (7.90 to 28.75)
Cumulative incidence rate of competing risks	10.42 (3.82 to 20.86)

Population analysed: All patients

Primary outcome: Cumulative Incidence Rate of Local Recurrence and Competing Risks (Liposarcoma Well Differentiated)

Time frame: 3 years from start of the tomotherapy treatment. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Radiotherapy n = 20
Cumulative incidence rate of local recurrence	5.00 (0.35 to 20.53)
Cumulative incidence rate of competing risks	5.00 (0.35 to 20.53)

Population analysed: Analysis for the 20 patients with well-differentiated liposarcoma

Primary outcome: Cumulative Incidence Rate of Local Recurrence and Competing Risks (Liposarcoma Dedifferentiated or Pleomorphic)

Time frame: 3 years from start of the tomotherapy treatment. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Radiotherapy n = 28
Cumulative incidence rate of local recurrence	25.71 (11.36 to 42.82)
Cumulative incidence rate of competing risks	14.29 (4.50 to 29.50)

Population analysed: Analysis for the 28 patients with dedifferentiated or pleomorphic liposarcoma

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 5 years (all the study period for a patient, from date of inclusion to date of end of study). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Radiotherapy	30 of 48 (62.5%)	0 of 0	13 of 48

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 37437608Sargos 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.

Related trials for Liposarcoma

RecruitingPhase 3
Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas
Metastatic Dedifferentiated Liposarcoma, Metastatic Undifferentiated Pleomorphic Sarcoma
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Spearhead 1 Study in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

KANTOR Guy, PU-PH study chair

Institut Bergonié

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Radiotherapy in people with Liposarcoma, run by Institut Bergonié at 5 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative Incidence Rate of Local Recurrence and Competing Risks (All Patients) (time frame: 3 years from start of the tomotherapy treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01841047, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.