Prospective Study on the Sparing of Organs at Risk in High Dose Rate Brachytherapy for Cervix Cancer
Data Collection
Collected from today forward - ProspectiveUrogenital Diseases+10
+ Genital Diseases
+ Uterine Cervical Diseases
Case-Only
Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.Summary
Study start date: June 1, 2011
Actual date on which the first participant was enrolled.After 60 Gy are delivered with Intensity Modulated Radiation Therapy (IMRT), the brachytherapy in high dose rate will deliver 15 Gy to the CTVhr (high risk CTV) in two sessions. A clinical examination and an RMN are performed at the end of the external radiation to evaluate the residual tumoral volume. Two HDR brachytherapy sessions are then performed. During the first session, a CT-Scan and an RMN will be performed after the fletcher application. A second CT-Scan will be performed during the second treatment session to create new volumes and to improve organs at risk sparing.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.24 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-only
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: Cervix carcinoma stage Ib to IV (FIGO) OMS < 2 Tomography by positron emission and/or chirurgical staging before the external radiotherapy RMN before the starting of treatment and at the end af external radiotherapy Patient information Validation of the indication af high dose rate brachytherapy External radiation therapy (60 Gy with IMRT) Exclusion Criteria: No external radiation therapy Surgery in the 4 weeks before before the inclusion Prior pelvic radiation therapy intestinal inflammatory disease or active pathology active infection or severe pathology didn't allow the treatment Prior carcinoma in the last 5 years (except cutaneous carcinoma or in situ carcinoma) Inclusion in another clinical trial
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location