Adaptative Radiotherapy for Locally Advanced Cervical Cancer (ARCOL)

Center Eugene Marquis

Status: Completed

Conditions: Uterine Cervical Cancer

Treatments: Radiation: External radiotherapy; Other: Adaptative treatment plan

Study type: Interventional

Funder types: Other

Identifiers

NCT02937948

2015-02-45-01

Details and patient eligibility

About

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.

Enrollment: 85 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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85 participants in 1 patient group

Adaptative Treatment plans

Experimental group

Description:

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.

Treatment:

Radiation: External radiotherapy

Other: Adaptative treatment plan