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Adaptative Radiotherapy for Locally Advanced Cervical Cancer (ARCOL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02937948
Recruitment Status : Recruiting
First Posted : October 19, 2016
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Uterine Cervical Cancer Other: Adaptative treatment plan Radiation: External radiotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 79 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Phase II Study of Adaptative Radiotherapy for Locally Advanced Cervical Cancer
Actual Study Start Date : April 5, 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
Experimental: Adaptative Treatment plans
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.
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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02937948


Contacts
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Contact: Renaud de Crevoisier, Professor +33299253031 r.de-crevoisier@rennes.unicancer.fr
Contact: Martine Gestin, PhD +33299253036 m.gestin@rennes.unicancer.fr

Locations
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France
Institut de Cancérologie de l'Ouest Recruiting
Angers, France, 49933
Contact: Nathalie Mesgouez-Nebout, MD    +33241352911    nathalie.mesgouez-nebout@ico.unicancer.fr   
Principal Investigator: Nathalie Mesgouez-Nebout, MD         
Centre François Baclesse Recruiting
Caen, France, 14000
Contact: Nejla Allouache, MD    +33231455033    n.allouache@baclesse.fr   
Principal Investigator: Nejla Allouache, MD         
CLCC Georges François Leclerc Recruiting
Dijon, France, 21034
Contact: Karine Peignaux, MD    +33380737518    kpeignaux@cgfl.fr   
Principal Investigator: Karine Peignaux, MD         
Centre Oscar Lambret Recruiting
Lille, France
Contact: Florence Le Tinier, MD         
Principal Investigator: Florence Le Tinier, MD         
Centre Léon Bérard Not yet recruiting
Lyon, France
Contact: Séverine Racadot, MD         
Principal Investigator: Séverine Racadot, MD         
Centre rené Gauducheau Recruiting
Nantes, France, 44805
Contact: Magali Leblanc-Onfroy, MD    +33240679955    magali.le-blanc@ico.unicancer.fr   
Principal Investigator: Magali Leblanc-Onfroy, MD         
CHU Poitiers Not yet recruiting
Poitiers, France, 86021
Contact: Antoine Berger, MD    +33549444485    antoine.berger@chu-poitiers.fr   
Principal Investigator: Antoine Berger, MD         
Centre Eugène Marquis Recruiting
Rennes, France, 35042
Contact: Renaud de Crevoisier, Professor    +33299253031    r.de-crevoisier@rennes.unicancer.fr   
Principal Investigator: Renaud de Crevosier, Professor         
Centre Henri Becquerel Recruiting
Rouen, France, 76038
Contact: Chantal Hanzen, MD    +33232082485    chantal.hanzen@chb.unicancer.fr   
Principal Investigator: Chantal Hanzen, MD         
CHU de Tours Not yet recruiting
Tours, France, 37044
Contact: Isabelle Barillot, Professor    +33247474747    i.barillot@chu-tours.fr   
Principal Investigator: Isabelle Barillot, Professor         
Centre Alexis Vautrin Recruiting
Vandoeuvre Les Nancy, France, 54500
Contact: Sophie Oldrini-Renard, MD    +33383598534    s.renard@nancy.unicancer.fr   
Principal Investigator: Sophie Oldrini-Renard, MD         
Gustave Roussy Not yet recruiting
Villejuif, France, 94805
Contact: Christine Haie-Meder, MD    +33142114211    christine.haiemeder@igr.fr   
Principal Investigator: Christine Haie-Meder, MD         
Sponsors and Collaborators
Center Eugene Marquis

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Responsible Party: Center Eugene Marquis
ClinicalTrials.gov Identifier: NCT02937948    
Other Study ID Numbers: 2015-02-45-01
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not authorized in France

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Center Eugene Marquis:
Locally advanced
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female