Brief Title
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
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.
Study Type
Interventional
Primary Outcome
change from baseline in acute toxicity all along the radiation
Secondary Outcome
geriatric intervention
Condition
Endometrial Cancer
Intervention
3D conformational radiation
Study Arms / Comparison Groups
3D conformational radiotherapy
Description: 25 * 1.8 Gy in 5 weeks (=45 Gy). 3D conformational radiation
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Radiation
Estimated Enrollment
26
Start Date
May 2012
Completion Date
October 2016
Primary Completion Date
October 2016
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
Gender
Female
Ages
70 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Le Tinier Florence, MD, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT01641497
Organization ID
TOMOGYN - 1105
Secondary IDs
2011-A01543-38
Responsible Party
Sponsor
Study Sponsor
Centre Oscar Lambret
Collaborators
National Cancer Institute, France
Study Sponsor
Le Tinier Florence, MD, Principal Investigator, Centre Oscar Lambret
Verification Date
July 2017