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

Endometrial Cancer Clinical Trial

— TOMOGYN  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01641497
• Other study ID #: TOMOGYN - 1105
• Secondary ID: 2011-A01543-38
• Status: Terminated
• Phase: N/A
• First received: July 9, 2012
• Last updated: July 19, 2017
• Start date: May 2012
• Est. completion date: October 2016

Study information

• Verified date: July 2017
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

Radiation:
• 3D conformational radiation
25 * 1.8 Gy in 5 weeks (=45 Gy)
• IMRT
25 * 1.8 Gy in 5 weeks (=45 Gy)

Locations

Country	Name	City	State
France	Bergonie Institut	Bordeaux
France	François Baclesse Center	Caen
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

Sponsors (2)

Lead Sponsor	Collaborator
Centre Oscar Lambret	National Cancer Institute, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	geriatric intervention	number of intervention, consequences in terms of base treatment change, intervention of other specialists (except cancer)	up to 6 months
Secondary	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
Secondary	duration of the radiation	interval between first day and last day of treatment	up to 5 weeks and a half
Secondary	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
Secondary	late major toxicity	NCI CTCAE v 4.0	1 week, 8 weeks, 6, 12, 18 and 24 months after the end of treatment
Secondary	progression free survival	median time between date of inclusion and date of clinical or radialogical progression	an average period of 2 years