Adaptative Radiotherapy for Locally Advanced Cervical Cancer

Not Applicable

Completed

• Conditions: Uterine Cervical Cancer

• 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

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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

CLCC Georges François Leclerc; 🇫🇷 Dijon, France

Centre Oscar Lambret; 🇫🇷 Lille, France

Centre Léon Bérard; 🇫🇷 Lyon, France

Centre rené Gauducheau; 🇫🇷 Nantes, France

CHU Poitiers; 🇫🇷 Poitiers, France

Centre Eugène Marquis; 🇫🇷 Rennes, France

Centre Henri Becquerel; 🇫🇷 Rouen, France

CHU de Tours; 🇫🇷 Tours, France

Scroll for more (2 remaining)