Cervical Adenocarcinoma, Stage IB Cervical Cancer, Stage II Cervical Cancer, Stage III Cervical Cancer
Conditions
Keywords
Pulsed dose-rate brachytherapy, 3D dosimetry, Prospective Studies, Radiotherapy Dosage, Uterine Cervical Neoplasms/radiotherapy, Brachytherapy/methods
Brief summary
This prospective phase II trial study aims to optimize the increase in dose to the target volume at high risk (85 to 90 Gy over 90% of its volume) and the intermediate target volume (60 Gy to 90 % of its volume) in 3D Pulsed Dose Rate Brachytherapy in treating patients with locally advanced cervical cancer.
Detailed description
* The causes of treatment failure and death in cervical cancer are still often linked to a local cancer progression * The importance of local control for healing, than the cervix situation in the center of pelvis between bladder and rectum which are sensitive organs to irradiation justify the use of utero-vaginal brachytherapy * This open label, multicenter, phase II study evaluates the benefit of increasing in dose to the target volume at high risk and the intermediate target volume in 3D Pulsed Dose Rate Brachytherapy in treating patients with locally advanced cervical cancer. * Local control and tolerance are evaluated
Interventions
RADIATIONExternal Beam Radiation Therapy
45 Gy pelvis / 25 fr
RADIATIONPDR Brachytherapy
1 puls/hour ; 12 Gy / day
DRUGCisplatin
increase in dose to the target volume at high risk (85 to 90 Gy over 90% of its volume) and the intermediate target volume (60 Gy to 90 % of its volume) in 3D Pulsed Dose Rate Brachytherapy
Sponsors
Institut de Cancérologie de Lorraine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* primitive cervical cancer * adenocarcinoma histologically advanced * IB2, II and III stage * curative treatment * indication of utero-vaginal brachytherapy with external radiotherapy * non-metastatic tumor and life expectancy \> 6 months * patient informed and follow possible * performance status ≤ 2 * unplanned surgery * age ≥ 18 years old * ability to provide written informed consent before the start of any study specific procedures
Exclusion criteria
* primitive endometrial cancer * other diseases * carcinoma in situ and stages ≤ B * distant metastases * history of pelvic irradiation or a first pelvic cancer * contraindication to MRI * history of subtotal or total hysterectomy * pregnant or breast feeding females * inability to support low dose rate continuous brachytherapy or pulsed flow * person in emergencies * person unable to give personally consent * patient participating in another clinical research except in case of local recurrence or observational research
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Increase the local control rate | 24 months | Increasing local control in two years (from 71.0% to 86.7%) will be achieved by increasing the dose to the target volume (CTV and CTV-HR-RI) measured dose volume histograms |
Secondary
| Measure | Time frame |
|---|---|
| Maintain the cumulative rate grade III and IV complications below 6.5% | 24 months |
| Relationship between the doses delivered to the target volume and local control | 24 months |
| Relationship between the doses delivered to the critical organs and rate of grade III and IV complications | 24 months |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORPEIFFERT Didier
Institut de Cancérologie de Lorraine
Outcome results
None listed