Adaptative Radiotherapy for Locally Advanced Cervical Cancer

Center Eugene Marquis85 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Uterine Cervical Cancer

Interventions

Adaptative treatment planOTHER

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 radiotherapyRADIATION

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (12)

Institut de Cancérologie de l'Ouest

Angers, France

Centre François Baclesse

Caen, France

CLCC Georges François Leclerc

Dijon, France

Centre Oscar Lambret

Outcomes

Primary Outcomes

Number of patient having an Acute genito-urinary (GU) and Gastro-intestinal (GI) toxicities assessed by CTCAE V4.03

Time frame: 3 months after end of radio-chemotherapy treatment

Secondary Outcomes

Number of patient having a Grade ≥ 2 Hematologic and other toxicities assessed by CTCAE V4.03

Time frame: 3 months after end of radio-chemotherapy treatment

Data from ClinicalTrials.gov

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