Adaptative Radiotherapy for Locally Advanced Cervical Cancer

Uterine Cervical Cancer Clinical Trial

— ARCOL  

Official title:

Phase II Study of Adaptative Radiotherapy for Locally Advanced Cervical Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02937948
• Other study ID #: 2015-02-45-01
• Status: Completed
• Phase: N/A
• Start date: April 5, 2017
• Est. completion date: April 11, 2022

Study information

• Verified date: September 2022
• Source: Center Eugene Marquis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: April 11, 2022
• Est. primary completion date: May 27, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Uterine Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Other:
• 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.

Radiation:
• 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.

Locations

Country	Name	City	State
France	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	Centre Alexis Vautrin	Vandoeuvre Les Nancy
France	Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Center Eugene Marquis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of patient having a Grade = 2 Hematologic and other toxicities assessed by CTCAE V4.03		3 months after end of radio-chemotherapy treatment