Dose Optimization in 3D Pulsed Dose Rate Brachytherapy for Patients With Locally Advanced Cervical Cancer

Study Overview
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Brief Summary
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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
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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

Official Title
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A Prospective Open Label Phase II Study to Optimize the Dose in 3D Pulsed Dose Rate Brachytherapy in Patients With Locally Advanced Cervical Cancer

Conditions
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Cervical Adenocarcinoma, Stage IB Cervical Cancer, Stage II Cervical Cancer, Stage III Cervical Cancer

Intervention / Treatment
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* Radiation: External Beam Radiation Therapy
* Radiation: PDR Brachytherapy
* Drug: Cisplatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARM A<br>Dose Optimization in 3D Pulsed Dose Rate Brachytherapy | Radiation: External Beam Radiation Therapy<br>* 45 Gy pelvis / 25 fr<br>* Other names: EBRT;Radiation: PDR Brachytherapy<br>* 1 puls/hour ; 12 Gy / day<br>Drug: Cisplatin<br>* 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<br>* Other names: CDDP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase the local control rate | 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 | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulsed dose-rate brachytherapy, 3D dosimetry, Prospective Studies, Radiotherapy Dosage, Uterine Cervical Neoplasms/radiotherapy, Brachytherapy/methods