NCT02937948

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 19, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

April 5, 2017

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2020

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2022

Completed
Last Updated

September 2, 2022

Status Verified

September 1, 2022

Enrollment Period

3.1 years

First QC Date

October 13, 2016

Last Update Submit

September 1, 2022

Conditions

Uterine Cervical Cancer

Keywords

Locally advanced

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    3 months after end of radio-chemotherapy treatment

Study Arms (1)

Adaptative Treatment plans

EXPERIMENTAL

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 planRadiation: External radiotherapy

Interventions

Adaptative treatment planOTHER

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.

Adaptative Treatment plans
External radiotherapyRADIATION

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.

Adaptative Treatment plans

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Institut de Cancérologie de l'Ouest

Angers, 49933, France

Location

Centre François Baclesse

Caen, 14000, France

Location

CLCC Georges François Leclerc

Dijon, 21034, France

Location

Centre Oscar Lambret

Lille, France

Location

Centre Léon Bérard

Lyon, France

Location

Centre rené Gauducheau

Nantes, 44805, France

Location

CHU Poitiers

Poitiers, 86021, France

Location

Centre Eugène Marquis

Rennes, 35042, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

CHU de Tours

Tours, 37044, France

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54500, France

Location

Gustave Roussy

Villejuif, 94805, France

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2016

First Posted

October 19, 2016

Study Start

April 5, 2017

Primary Completion

May 27, 2020

Study Completion

April 11, 2022

Last Updated

September 2, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Not authorized in France

Locations

FR(12)