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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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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