Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiotherapy | Other | Evaluation of the combination of radiotherapy with helical tomotherapy (54 Gy) followed by surgery in retro-peritoneal liposarcomas. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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. |
| 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| KANTOR Guy, PU-PH | Institut Bergonié | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Paul Strauss | Strasbourg | Alsace | 67000 | France | ||
| Institut Bergonié |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37437608 | Background | 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. |
Not provided
Not provided
Not provided
3 recruitment centers :
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Radiotherapy | Evaluation of the combination of radiotherapy with helical tomotherapy (54 Gy) followed by surgery in retro-peritoneal liposarcomas. Helical tomotherapy (54 Gy) will take place over 6 consecutive weeks with 30 fractions of 1.8 Gy : 5 fractions per week followed by 2 days off. The surgery takes place between 2 and 8 weeks after the end of the tomotherapy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All patients | Posted | Number | 95% Confidence Interval | percentage of participants | 3 years from start of the tomotherapy treatment |
|
5 years (all the study period for a patient, from date of inclusion to date of end of study)
Only for SAEs were monitored/assessed. Other [Not Including Serious] Adverse Events were not monitored/assessed (so Total Number At Risk = 0).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (5.0) | Non-systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pr Guy KANTOR | Institut Bergonié | G.Kantor@bordeaux.unicancer.fr |
Not provided
| ID | Term |
|---|---|
| D008080 | Liposarcoma |
| ID | Term |
|---|---|
| D018205 | Neoplasms, Adipose Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 3 years from start of the tomotherapy treatment |
| 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 |
| Bordeaux |
| Aquitaine |
| 33000 |
| France |
| Centre Claudius Regaud | Toulouse | Midi-Pyrénées | 31000 | France |
| Centre René Gauducheau | Nantes | Pays de la Loire Region | 44000 | France |
| Institut Curie | Paris | ÃŽle-de-France Region | 75000 | France |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| WHO status | The WHO performance status classification categorises patients as: 0: able to carry out all normal activity without restriction
| 1 patient with data not available | Count of Participants | Participants |
|
| Histotype | Sub histological type of liposarcoma | Count of Participants | Participants |
|
| OG000 | 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 |
|
|
| Primary | 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. | Analysis for the 20 patients with well-differentiated liposarcoma | Posted | Number | 95% Confidence Interval | percentage of participants | 3 years from start of the tomotherapy treatment |
|
|
|
| Primary | 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. | Analysis for the 28 patients with dedifferentiated or pleomorphic liposarcoma | Posted | Number | 95% Confidence Interval | percentage of participants | 3 years from start of the tomotherapy treatment |
|
|
|
| Secondary | 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). | All patients | Posted | Number | 95% Confidence Interval | percentage of participants | 3 years from start of the tomotherapy treatment |
|
|
|
| Secondary | 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). | Analysis for the 20 patients with well-differentiated liposarcoma | Posted | Number | 95% Confidence Interval | percentage of participants | 3 years from start of the tomotherapy treatment |
|
|
|
| Secondary | 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). | Analysis for the 28 patients with dedifferentiated or pleomorphic liposarcoma | Posted | Number | 95% Confidence Interval | percentage of participants | 3 years from start of the tomotherapy treatment |
|
|
|
| Secondary | 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). | All patients | Posted | Number | 95% Confidence Interval | percentage of participants | 1 year, 3 years and 5 years from start of the tomotherapy treatment |
|
|
|
| 13 |
| 48 |
| 30 |
| 48 |
| 0 |
| 0 |
| Adrenal insufficiency | Endocrine disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Colonic fistula | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Gastrointestinal fistula | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Rectal hemorrhage | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Death NOS | General disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Disease progression | General disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Sudden death NOS | General disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Abdominal infection | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
|
| Infections and infestations - Other, specify | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
|
| Lung infection | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
|
| Skin infection | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
|
| Postoperative hemorrhage | Injury, poisoning and procedural complications | CTCAE (5.0) | Non-systematic Assessment |
|
| Vascular access complication | Injury, poisoning and procedural complications | CTCAE (5.0) | Non-systematic Assessment |
|
| Weight loss | Investigations | CTCAE (5.0) | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Metabolism and nutrition disorders - Other, specify | Metabolism and nutrition disorders | CTCAE (5.0) | Non-systematic Assessment |
|
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (5.0) | Non-systematic Assessment |
|
| Treatment related secondary malignancy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (5.0) | Non-systematic Assessment |
|
| Lymphocele | Vascular disorders | CTCAE (5.0) | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D012509 | Sarcoma |
|