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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
26
25 \* 1.8 Gy in 5 weeks (=45 Gy)
25 \* 1.8 Gy in 5 weeks (=45 Gy)
Bergonie Institut
Bordeaux, France
François Baclesse Center
Caen, France
Oscar Lambret Center
Lille, France
Centre Leon Berard
Lyon, France
change from baseline in acute toxicity all along the radiation
NCI CTCAE v 4.0 tox \> grade 2 will be compared
Time frame: baseline, Day 5, Day 10, Day 15, Day 20, Day 25, 1 Week after end of treatment, 8 Weeks after end of treatment
geriatric intervention
number of intervention, consequences in terms of base treatment change, intervention of other specialists (except cancer)
Time frame: 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
Time frame: baseline, 6 months after end of treatment
duration of the radiation
interval between first day and last day of treatment
Time frame: up to 5 weeks and a half
quality of life
QLQ C30 questionnaire
Time frame: 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
Time frame: 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
Time frame: an average period of 2 years
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Institut Jean Godinot
Reims, France
René Gauducheau Center
Saint-Herblain, France
Paul Strauss Center
Strasbourg, France