Clinical trial · Interventional
Exclusion of Non-involved Uterus From the Target Volume in Locally Advanced Cervical Cancer
Exclusion of Non-involved Uterus Form the Target Volume: an Individualized Treatment for Locally Advanced Cervical Cancer Using Modern Radiotherapy and Imaging Techniques
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Cervical Neoplasms | Cervical Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| treatment with EXIT-target volume | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- treatment with EXIT-target volume
- description
- 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.
- interventionNames
- Other: treatment with EXIT-target volume
Primary outcomes (1)
- measure
- safety: abscence of tumor in the non-involved and non-high doses irradiated part of the uterus
- timeFrame
- within 3 months after last inclusion
- description
- 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
Secondary outcomes (5)
- measure
- dosimetry
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDVandecasteele 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 30223802