Clinical trial NCT01641497: Phase III Study Comparing 3D Conformal Radiotherapy and Conformal Radiotherapy IMRT to Treat Endometrial Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Endometrial Cancer
Keywords: endometrial cancer
IMRT
age over 70
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
Collaborators: name: National Cancer Institute, France
First posted: 2012-07-16
Enrollment: 26
Sex: FEMALE
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: change from baseline in acute toxicity all along the radiation
timeFrame: baseline, Day 5, Day 10, Day 15, Day 20, Day 25, 1 Week after end of treatment, 8 Weeks after end of treatment
Secondary outcomes:
measure: geriatric intervention
timeFrame: up to 6 months
measure: geriatric repercussion
timeFrame: baseline, 6 months after end of treatment
measure: duration of the radiation
timeFrame: up to 5 weeks and a half
measure: quality of life
timeFrame: 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
measure: late major toxicity
timeFrame: 1 week, 8 weeks, 6, 12, 18 and 24 months after the end of treatment
measure: progression free survival
timeFrame: an average period of 2 years
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Bergonie Institut
city: Caen
country: France
facility: François Baclesse Center
city: Lille
country: France
facility: Oscar Lambret Center
city: Lyon
country: France
facility: Centre Leon Berard
city: Reims
country: France
facility: Institut Jean Godinot
city: Saint Herblain
country: France
facility: René Gauducheau Center
city: Strasbourg
country: France
facility: Paul Strauss Center
Study officials:
affiliation: Centre Oscar Lambret
name: Le Tinier Florence, MD
role: PRINCIPAL_INVESTIGATOR
References: