Endometrial Cancer
Conditions
Keywords
endometrial cancer, IMRT, age over 70
Brief summary
Comparison of radiotherapy tolerance (two types of radiotherapy) for patients over 70 years with a endometrial cancer.
Detailed description
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.
Interventions
RADIATION3D conformational radiation
25 \* 1.8 Gy in 5 weeks (=45 Gy)
RADIATIONIMRT
25 \* 1.8 Gy in 5 weeks (=45 Gy)
Sponsors
National Cancer Institute, France
Centre Oscar Lambret
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* endometrial adenocarcinoma histologically proven * post op pelvic radiotherapy * age ≥ 70 * performance status ≤ 2 * MMSE ≥ 10 * life expectancy ≥ 3 months * social security covered * signed informed consent
Exclusion criteria
* type I stade IAGI and stade IAGIII without myometer infiltration, stade IIIc2 and IV adenocarcinoma * uterine sarcoma * surgery not in accordance with recommendations of Inca * previous uncontrolled or less than 5 years prior to diagnosis cancer * cons-indication for radiotherapy * diarrhea ≥ 3 per day * pelvic lymph nodes \> 1cm not resected during staging * previous sigmoid diverticulitis, crohn disease, systemic disease, ulcerative haemorrhagic, collagenosis, infectious peritonitis * IMRT other than tomotherapy * photon energy \< 10MV * patient under guardianship
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change from baseline in acute toxicity all along the radiation | baseline, Day 5, Day 10, Day 15, Day 20, Day 25, 1 Week after end of treatment, 8 Weeks after end of treatment | NCI CTCAE v 4.0 tox \> grade 2 will be compared |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| geriatric repercussion | baseline, 6 months after end of treatment | 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 |
| duration of the radiation | up to 5 weeks and a half | interval between first day and last day of treatment |
| geriatric intervention | up to 6 months | number of intervention, consequences in terms of base treatment change, intervention of other specialists (except cancer) |
| late major toxicity | 1 week, 8 weeks, 6, 12, 18 and 24 months after the end of treatment | NCI CTCAE v 4.0 |
| progression free survival | an average period of 2 years | median time between date of inclusion and date of clinical or radialogical progression |
| quality of life | 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 | QLQ C30 questionnaire |
Countries
France
Outcome results
None listed