Phase III Study Comparing 3D Conformal Radiotherapy and Conformal Radiotherapy IMRT to Treat Endometrial Cancer
- Conditions
- Endometrial Cancer
- Interventions
- Radiation: 3D conformational radiationRadiation: IMRT
- Registration Number
- NCT01641497
- Lead Sponsor
- Centre Oscar Lambret
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 26
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3D conformational radiotherapy 3D conformational radiation 25 \* 1.8 Gy in 5 weeks (=45 Gy). 3D conformational radiation Intensity-Modulated Radiation Therapy IMRT 25 \* 1.8 Gy in 5 weeks (=45 Gy). IMRT
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
geriatric intervention up to 6 months number of intervention, consequences in terms of base treatment change, intervention of other specialists (except cancer)
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
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
duration of the radiation up to 5 weeks and a half interval between first day and last day of treatment
Trial Locations
- Locations (7)
François Baclesse Center
🇫🇷Caen, France
Bergonie Institut
🇫🇷Bordeaux, France
Oscar Lambret Center
🇫🇷Lille, France
Centre Leon Berard
🇫🇷Lyon, France
Institut Jean Godinot
🇫🇷Reims, France
René Gauducheau Center
🇫🇷Saint Herblain, France
Paul Strauss Center
🇫🇷Strasbourg, France