ARCOL: Adaptative Radiotherapy for Locally Advanced Cervical Cancer

Sponsor

Center Eugene Marquis (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02937948

Collaborator

(none)

Enrollment

Locations

Arm

59.9

Anticipated Duration (Months)

6.6

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Uterine Cervical Cancer	Other: Adaptative treatment plan Radiation: External radiotherapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

79 participants

Allocation:

N/A

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 :

Apr 5, 2017

Actual Primary Completion Date :

May 27, 2020

Anticipated Study Completion Date :

Apr 1, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Number of patient having a Grade ≥ 2 Hematologic and other toxicities assessed by CTCAE V4.03 [3 months after end of radio-chemotherapy treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Institut de Cancérologie de l'Ouest	Angers	France	49933
2	Centre François Baclesse	Caen	France	14000
3	CLCC Georges François Leclerc	Dijon	France	21034
4	Centre Oscar Lambret	Lille	France
5	Centre Léon Bérard	Lyon	France
6	Centre rené Gauducheau	Nantes	France	44805
7	CHU Poitiers	Poitiers	France	86021
8	Centre Eugène Marquis	Rennes	France	35042
9	Centre Henri Becquerel	Rouen	France	76038
10	CHU de Tours	Tours	France	37044
11	Centre Alexis Vautrin	Vandoeuvre Les Nancy	France	54500
12	Gustave Roussy	Villejuif	France	94805

Sponsors and Collaborators

Center Eugene Marquis

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Center Eugene Marquis

ClinicalTrials.gov Identifier:

NCT02937948

Other Study ID Numbers:

2015-02-45-01

First Posted:

Oct 19, 2016

Last Update Posted:

Jan 26, 2022

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Center Eugene Marquis

Locally advanced

Additional relevant MeSH terms:

Uterine Cervical Neoplasms

Study Results

No Results Posted as of Jan 26, 2022