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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-A01543-38 | Other Identifier | DEDIM (ANSM) |
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Recruitment difficulties
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| Name | Class |
|---|---|
| National Cancer Institute, France | OTHER_GOV |
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Comparison of radiotherapy tolerance (two types of radiotherapy) for patients over 70 years with a endometrial cancer.
Endometrial cancer is the most common form of gynecological cancer in France with 6560 new cases in 2010. Endometrial cancers occurs generally after menopause but are sometimes diagnosticated before 40 years. The 5 years Overall survival of endometrial cancer is 76% (95% for non locally advanced or non metastatic disease).
Some factors are involved in disease prognostic: age, geographical origin, physical status, tumor grade, tumor histology and probably biomarkers. Some studies demonstrated that advanced age is a negative prognostic factor due to higher relapse risk and higher specific mortality. Unfortunately, Incidence of endometrial cancer will probably increase in future due to aging of the occidental population.
Current treatment of endometrial cancer is based on post-operative radiation therapy: adjuvant brachytherapy or adjuvant external beam radiation therapy. However these techniques lead to serious toxicity (digestive toxicity, ileitis...) in elder patient. Consequently, pelvic radiation therapy is difficult to organize before 75 years and dangerous to perform after 80 years.
However a new technique called: Intensity-modulated radiation therapy (IMRT) can make the difference. IMRT is a new high precision radiotherapy technique probably well adapted for old people, with less toxicity than current radiotherapy.
Nevertheless, IMRT is not recognized as a standard radiation therapy procedure in France and Europe.
Thus, goal of TOMOGYN study is to compare the tolerance of old women (at least 70 years), with endometrial cancer, treated with external beam radiation therapy or IMRT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3D conformational radiotherapy | Active Comparator | 25 * 1.8 Gy in 5 weeks (=45 Gy). 3D conformational radiation |
|
| Intensity-Modulated Radiation Therapy | Experimental | 25 * 1.8 Gy in 5 weeks (=45 Gy). IMRT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D conformational radiation | Radiation | 25 * 1.8 Gy in 5 weeks (=45 Gy) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline in acute toxicity all along the radiation | NCI CTCAE v 4.0 tox > grade 2 will be compared | baseline, Day 5, Day 10, Day 15, Day 20, Day 25, 1 Week after end of treatment, 8 Weeks after end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| geriatric intervention | number of intervention, consequences in terms of base treatment change, intervention of other specialists (except cancer) | up to 6 months |
| geriatric repercussion | scales : Activities in Daily Living (ADL), Instrumental Activities in Daily Living (IADL), Mini Nutritionnal Assessment (MNA), Geriatric Depression Scale (GDS), cognitive evaluation, Cumulative Illness RAting Scale-Geriatrics (CIRS-G), sociocultural questionnaire, walking and balance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Le Tinier Florence, MD | Centre Oscar Lambret | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bergonie Institut | Bordeaux | 33076 | France | |||
| François Baclesse Center |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| IMRT |
| Radiation |
25 * 1.8 Gy in 5 weeks (=45 Gy) |
|
| baseline, 6 months after end of treatment |
| duration of the radiation | interval between first day and last day of treatment | up to 5 weeks and a half |
| quality of life | QLQ C30 questionnaire | baseline, Day 5, Day 10, Day 15, Day 20, Day 25, 1 week and 8 weeks after end of treatment, 6, 12, 18 and 24 months after end of treatment |
| late major toxicity | NCI CTCAE v 4.0 | 1 week, 8 weeks, 6, 12, 18 and 24 months after the end of treatment |
| progression free survival | median time between date of inclusion and date of clinical or radialogical progression | an average period of 2 years |
| Caen |
| 14076 |
| France |
| Oscar Lambret Center | Lille | 59020 | France |
| Centre Leon Berard | Lyon | 69373 | France |
| Institut Jean Godinot | Reims | 51726 | France |
| René Gauducheau Center | Saint-Herblain | 44805 | France |
| Paul Strauss Center | Strasbourg | 67065 | France |
| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |