Adaptative Radiotherapy for Locally Advanced Cervical Cancer

Not Applicable

Completed

• Conditions: Uterine Cervical Cancer
• Interventions: Other: Adaptative treatment plan; Radiation: External radiotherapy

• Registration Number: NCT02937948
• Lead Sponsor: Center Eugene Marquis

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-10-13
• Study First Submitted QC: 2016-10-17
• Study First Posted: 2016-10-19
• Study Start: 2017-04-05
• Primary Completion: 2020-05-27
• Study Completion: 2022-04-11
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-01
• Last Update Posted: 2022-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 85

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adaptative Treatment plans	Adaptative treatment plan	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.
Adaptative Treatment plans	External radiotherapy	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Number of patient having a Grade ≥ 2 Hematologic and other toxicities assessed by CTCAE V4.03	3 months after end of radio-chemotherapy treatment

Trial Locations

Locations (12)

Institut de Cancérologie de l'Ouest; 🇫🇷 Angers, France

Centre François Baclesse; 🇫🇷 Caen, France

Centre Oscar Lambret; 🇫🇷 Lille, France

Centre Alexis Vautrin; 🇫🇷 Vandoeuvre Les Nancy, France

Centre Léon Bérard; 🇫🇷 Lyon, France

CLCC Georges François Leclerc; 🇫🇷 Dijon, France

Centre rené Gauducheau; 🇫🇷 Nantes, France

CHU de Tours; 🇫🇷 Tours, France

CHU Poitiers; 🇫🇷 Poitiers, France

Centre Eugène Marquis; 🇫🇷 Rennes, France

Centre Henri Becquerel; 🇫🇷 Rouen, France

Gustave Roussy; 🇫🇷 Villejuif, France