NCT03542942

Brief Summary

Both toxicity and local relapse are major concerns in the treatment of locally advanced cervical cancer. The purpose of this study is to ameliorate both by integrating modern imaging (diffusion weighted magnetic resonance imaging; DW-MRI) into the treatment planning of modern radiotherapy. We want to evaluate the safety and effect of excluding the unaffected uterus (as determined on magnetic resonance imaging) from the treatment field. Meanwhile we want to explore the possible use of apparent diffusion coefficient values (DW-MRI) as biomarker of treatment response.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

March 30, 2016

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

May 3, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 31, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2020

Completed
Last Updated

December 19, 2022

Status Verified

December 1, 2022

Enrollment Period

4.5 years

First QC Date

May 3, 2018

Last Update Submit

December 16, 2022

Conditions

Uterine Cervical Neoplasms

Keywords

locally advancedradiotherapyDW-MRItarget volume

Outcome Measures

Primary Outcomes (1)

  • safety: abscence of tumor in the non-involved and non-high doses irradiated part of the uterus

    abscence of tumor in the non-involved (as determined on the pre-treatment MRI) and non-high doses irradiated part of the uterus in the hysterectomy specimen after CRT

    within 3 months after last inclusion

Secondary Outcomes (5)

  • dosimetry

    within 3 months after last inclusion

  • number of participants with treatment-related adverse events as assessed by the radiotherapy oncology group toxicity criteria and CTCAEv4.0 for hematology

    during treatment. 10 days, 1 months and 3 months after ending treatment

  • number of participants with treatment-related adverse events as assessed by the radiotherapy oncology group toxicity criteria and CTCAEv4.0

    6, 12, 18 and 24 months after treatment.

  • local, regional and distant control

    1, 3, 6, 12,18 and 24 months after treatment

  • Correlation of high-Risk regions on IMaging (DW-MRI) with Pathology and regression pattern analysis (CRIMP).

    Within 6 months after surgery of the last patient

Study Arms (1)

treatment with EXIT-target volume

OTHER

The radiotherapeutic treatment plan is based on an EXIT-target volume in which the non-involved uterus is excluded from the target volume. All other delineations are performed conform standard of care.

Other: treatment with EXIT-target volume

Interventions

treatment with EXIT-target volumeOTHER

exclusion of the unaffected part of the uterus out of the treatment field

treatment with EXIT-target volume

Eligibility Criteria

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

You may qualify if:

  • Biopsy proven carcinoma of the uterine cervix
  • locally advanced disease (FIGO IB2 or \>FIGO IIB or node positive) proven by clinical examination, 18-fluorodeoxyglucose positron emission tomography scan (18FDG PET-CT) and MRI
  • no more than 2 distant metastases (other than para-aortic lymph nodes);
  • WHO 0-2;
  • adequate kidney function for CRT, if inadequate kidney function radiotherapy can be the sole therapeutic regimen;
  • not pregnant or breastfeeding
  • absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; - willing and able to sign a written informed consent.

You may not qualify if:

  • Patients unable to undergo MRI for any reason.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radiotherapy Department Ghent University Hospital

Ghent, 9000, Belgium

Location

Related Publications (1)

  • Vandecasteele K, Tummers P, Van Bockstal M, De Visschere P, Vercauteren T, De Gersem W, Denys H, Naert E, Makar A, De Neve W. EXclusion of non-Involved uterus from the Target Volume (EXIT-trial): an individualized treatment for locally advanced cervical cancer using modern radiotherapy and imaging techniques. BMC Cancer. 2018 Sep 17;18(1):898. doi: 10.1186/s12885-018-4800-0.

    PMID: 30223802DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Therapeutics

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 Officials

  • Katrien Vandecasteele, MD, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 3, 2018

First Posted

May 31, 2018

Study Start

March 30, 2016

Primary Completion

September 22, 2020

Study Completion

September 22, 2020

Last Updated

December 19, 2022

Record last verified: 2022-12

Locations

BE(1)