Phase III Study Comparing 3D Conformal Radiotherapy and Conformal Radiotherapy IMRT to Treat Endometrial Cancer

Study Overview
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Brief Summary
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Comparison of radiotherapy tolerance (two types of radiotherapy) for patients over 70 years with a endometrial cancer.

Detailed Description
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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.

Official Title
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Phase III Study Comparing 3D Conformal Radiotherapy and Conformal Radiotherapy IMRT to Treat Endometrial Cancer of 70 Years Old Women : Contribution of Oncogeriatric Evaluation to the Study of Acute Toxicity

Conditions
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Endometrial Cancer

Intervention / Treatment
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* Radiation: 3D conformational radiation
* Radiation: IMRT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 3D conformational radiotherapy<br>25 * 1.8 Gy in 5 weeks (=45 Gy). 3D conformational radiation | Radiation: 3D conformational radiation<br>* 25 * 1.8 Gy in 5 weeks (=45 Gy)<br>|
| Experimental: Intensity-Modulated Radiation Therapy<br>25 * 1.8 Gy in 5 weeks (=45 Gy). IMRT | Radiation: IMRT<br>* 25 * 1.8 Gy in 5 weeks (=45 Gy)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endometrial cancer, IMRT, age over 70