Exclusion of Non-involved Uterus From the Target Volume in Locally Advanced Cervical Cancer

NCT03542942CompletedNAINTERVENTIONAL

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.

Key Facts

Lead Sponsor

University Hospital, Ghent

Enrollment

21

Start Date

2016-03-30

Completion Date

2020-09-22

Study Type

INTERVENTIONAL

Official Title

Exclusion of Non-involved Uterus Form the Target Volume: an Individualized Treatment for Locally Advanced Cervical Cancer Using Modern Radiotherapy and Imaging Techniques

Interventions

treatment with EXIT-target volume

Conditions

Uterine Cervical Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Patients unable to undergo MRI for any reason.

Outcome Measures

Primary Outcomes

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

Time frame: within 3 months after last inclusion

Secondary Outcomes

dosimetry

dosimetric comparison of dose on the OARs when comparing study treatment plans compared to treatment of the whole uterus at high doses

Time frame: 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

evaluation of acute toxicity, grade 0 (no toxicity) to grade 5 (treatment related death).

Time frame: 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

evaluation chronic toxicity, grade 0 (no toxicity) to grade 5 (treatment related death).

Time frame: 6, 12, 18 and 24 months after treatment.

local, regional and distant control

defined as absence of disease at the primary tumor bed, the regional lymph nodes and distant sites

Time frame: 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).

The MRI at fixed time points will be supplemented with diffusion weighing (DW). The ultimate aim is the correlation of tumoral ADC-values of the different DW-MRI with the pathology in order to predict therapy resistance or response to CRT at an early stage or even before start.

Time frame: Within 6 months after surgery of the last patient

Locations

Radiotherapy Department Ghent University Hospital, Ghent, Belgium

Linked Diseases

Uterine Cervical Neoplasms

Uterine Cervical Neoplasms — a type of gynecological cancer.