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Adaptative Radiotherapy for Locally Advanced Cervical Cancer (ARCOL)

Primary Purpose

Uterine Cervical Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Adaptative treatment plan
External radiotherapy
Sponsored by
Center Eugene Marquis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Uterine Cervical Cancer focused on measuring Locally advanced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Institut de Cancérologie de l'Ouest
  • Centre François Baclesse
  • CLCC Georges François Leclerc
  • Centre Oscar Lambret
  • Centre Léon Bérard
  • Centre rené Gauducheau
  • CHU Poitiers
  • Centre Eugène Marquis
  • Centre Henri Becquerel
  • CHU de Tours
  • Centre Alexis Vautrin
  • Gustave Roussy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adaptative Treatment plans

Arm 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.

Outcomes

Primary Outcome Measures

Number of patient having an Acute genito-urinary (GU) and Gastro-intestinal (GI) toxicities assessed by CTCAE V4.03

Secondary Outcome Measures

Number of patient having a Grade ≥ 2 Hematologic and other toxicities assessed by CTCAE V4.03

Full Information

First Posted
October 13, 2016
Last Updated
September 1, 2022
Sponsor
Center Eugene Marquis
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1. Study Identification

Unique Protocol Identification Number
NCT02937948
Brief Title
Adaptative Radiotherapy for Locally Advanced Cervical Cancer
Acronym
ARCOL
Official Title
Phase II Study of Adaptative Radiotherapy for Locally Advanced Cervical Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
April 5, 2017 (Actual)
Primary Completion Date
May 27, 2020 (Actual)
Study Completion Date
April 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center Eugene Marquis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Cervical Cancer
Keywords
Locally advanced

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adaptative Treatment plans
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Adaptative treatment plan
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
External radiotherapy
Intervention Description
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 Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Institut de Cancérologie de l'Ouest
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
Centre François Baclesse
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
CLCC Georges François Leclerc
City
Dijon
ZIP/Postal Code
21034
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
Country
France
Facility Name
Centre rené Gauducheau
City
Nantes
ZIP/Postal Code
44805
Country
France
Facility Name
CHU Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Centre Eugène Marquis
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
CHU de Tours
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Centre Alexis Vautrin
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54500
Country
France
Facility Name
Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Not authorized in France

Learn more about this trial

Adaptative Radiotherapy for Locally Advanced Cervical Cancer

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