Overview

This trial is active, not recruiting.

Condition endometrial cancer
Treatments 3d conformational radiation, imrt
Phase phase 3
Sponsor Centre Oscar Lambret
Collaborator National Cancer Institute, France
Start date May 2012
End date October 2016
Trial size 60 participants
Trial identifier NCT01641497, 2011-A01543-38, TOMOGYN - 1105

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Arm
(Active Comparator)
25 * 1.8 Gy in 5 weeks (=45 Gy). 3D conformational radiation
3d conformational radiation
25 * 1.8 Gy in 5 weeks (=45 Gy)
(Experimental)
25 * 1.8 Gy in 5 weeks (=45 Gy). IMRT
imrt
25 * 1.8 Gy in 5 weeks (=45 Gy)

Primary Outcomes

Measure
change from baseline in acute toxicity all along the radiation
time frame: 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
time frame: up to 6 months
geriatric repercussion
time frame: baseline, 6 months after end of treatment
duration of the radiation
time frame: up to 5 weeks and a half
quality of life
time frame: 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
time frame: 1 week, 8 weeks, 6, 12, 18 and 24 months after the end of treatment
progression free survival
time frame: an average period of 2 years

Eligibility Criteria

Male or female participants at least 70 years old.

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

Additional Information

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
Principal investigator Le Tinier Florence, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Centre Oscar Lambret.