Adaptative Radiotherapy for Locally Advanced Cervical Cancer

Study Overview
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Brief Summary
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This study evaluates the effect of adaptative Intensity-Modulated Radiation Therapy (IMRT) in the treatment of locally advanced cervical cancer on acute genito-urinary (GU), and gastrointestinal (GI) toxicities. Every patients will be treated according to the adaptative IMRT strategy.

Official Title
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Phase II Study of Adaptative Radiotherapy for Locally Advanced Cervical Cancer

Conditions
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Uterine Cervical Cancer

Intervention / Treatment
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* Other: Adaptative treatment plan
* Radiation: External radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cervix carcinoma proved by histology According International Federation of Gynecology and Obstetrics (FIGO) classification, stages IB2, IIA, IIB, IIIA and IIIB without lumbo-aortic lymph node damage (surgical or radiologic) Patient treated with radio-chemotherapy then curietherapy with curative aim, validated in multidisciplinary meeting Renal, hepatic and cardiovascular functions that allow administration of the associated systemic treatment Older than 18 years Good general status, World Health Organization less or equal to 1 Signed informed consent Exclusion Criteria: History of cancer that is not controlled and / or treated for less than 5 years (excepted for cutaneous baso-cellular cancer) History of pelvic irradiation Simultaneous participation to another research that could interfere with the study results Pregnant or breastfeeding patient Patient under tutor or guardian Patient not able to respect medical follow-up for geographical, social or psychological reasons Not affiliated to a system of French social security

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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adaptative Treatment plans<br>A Library of treatment plans will be generated for each patient before starting radiochemotherapy (standard treatment). This Library will be created using CT-Scans with variable bladder filling (and hence different uterine positions). Each day of radiotherapy treatment, an appropriate plan is chosen based on Imaging that day. | Other: Adaptative treatment plan<br>* Each patient will have 3 scanners before treatment initiation. One corresponding to an empty bladder, one to an intermediate one, one to a full bladder.<br>Radiation: External radiotherapy<br>* At the time of each fraction of external radiotherapy, the most appropriate plan (empty, intermediate, full bladder) covering the target and sparing the organs at risk is chosen.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patient having an Acute genito-urinary (GU) and Gastro-intestinal (GI) toxicities assessed by CTCAE V4.03 |  | 3 months after end of radio-chemotherapy treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patient having a Grade ≥ 2 Hematologic and other toxicities assessed by CTCAE V4.03 |  | 3 months after end of radio-chemotherapy treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Locally advanced