Adaptative Radiotherapy for Locally Advanced Cervical Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-05

Study Completion Date

2022-04-11

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.

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Detailed Description

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Conditions

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Uterine Cervical Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Adaptative Treatment plans

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.

Group Type EXPERIMENTAL

Adaptative treatment plan

Intervention Type OTHER

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.

External radiotherapy

Intervention Type RADIATION

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.

Interventions

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Adaptative treatment plan

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.

Intervention Type OTHER

External radiotherapy

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.

Intervention Type RADIATION

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No