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
Phase 3
70 Years
N/A
70 Years
N/A
Open (Enrolling)
Both
Endometrial Cancer
Both
Endometrial Cancer
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label
Outcome Measure:
change from baseline in acute toxicity all along the radiation
Outcome Description:
NCI CTCAE v 4.0 tox > grade 2 will be compared
Outcome 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
Safety Issue:
Yes
Authority:
France: Committee for the Protection of Personnes
Study ID:
TOMOGYN - 1105
NCT ID:
NCT01641497
Start Date:
April 2012
Completion Date:
April 2017
Related Keywords:
- Endometrial Cancer
- endometrial cancer
- IMRT
- age over 70
- Endometrial Neoplasms
- Sarcoma, Endometrial Stromal
- Adenoma
Name | Location |
|---|
