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

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

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

Study Overview

• Status: Terminated
• Conditions: Endometrial Cancer
• Intervention / Treatment: Radiation: 3D conformational radiation; Radiation: IMRT

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
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • Bergonié Institut
  • Caen, France, 14076
    • Francois Baclesse Center
  • Lille, France, 59020
    • Oscar Lambret Center
  • Lyon, France, 69373
    • Centre Léon Bérard
  • Reims, France, 51726
    • Institut Jean Godinot
  • Saint Herblain, France, 44805
    • René Gauducheau Center
  • Strasbourg, France, 67065
    • Paul Strauss Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Oscar Lambret
• Collaborators: National Cancer Institute, France
• Investigators: Principal Investigator: Le Tinier Florence, MD, Centre Oscar Lambret

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2012
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: July 9, 2012
• First Submitted That Met QC Criteria: July 12, 2012
• First Posted (Estimate): July 16, 2012

Study Record Updates

• Last Update Posted (Actual): July 21, 2017
• Last Update Submitted That Met QC Criteria: July 19, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: endometrial cancer; IMRT; age over 70
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Endometrial Neoplasms
• Other Study ID Numbers: TOMOGYN - 1105; 2011-A01543-38 (Other Identifier: DEDIM (ANSM))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No