An interventional study of treatment with EXIT-target volume in Uterine Cervical Neoplasms, sponsored by University Hospital, Ghent. Completed at 1 site in Belgium. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-19.
Sponsored by University Hospital, Ghent · Not applicable, Interventional, and Treatment
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.
In our previous research we successfully implemented Intensity Modulate Arc Therapy with concurrent administration of cisplatin 40mg/m2 weekly (IMAT-C) in the multimodality treatment of Locally Advanced Cervical Cancer (LACC) . By delivering a higher biological dose to the tumor and lowering the dose to the Organs at Risk (OARs), toxicity significantly dropped and local control improved. However, there remains room for improvement for both toxicity and response to the treatment. Macroscopic tumor rest on hysterectomy reflects the existence of chemoradiation (CRT) resistant foci and correlates with outcome. We hypothesize that both radiotherapy (RT)-related toxicity (a) as well as local response on CRT (b) can be improved by respectively:
To objectivize our hypotheses, we aim at:
Importance to the field: Both toxicity and local relapse are major concerns in the treatment of LACC. Grade ≥ 2 toxicity influences daily life of patients significantly and is present in the majority of patients treated and even with image guided BT local relapse remains the major cause of treatment failure.
1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.
This study's enrollment of 21 is below the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →University Hospital, Ghent is the lead sponsor of 665 studies on the registry; 156 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
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Exclusion Criteria:
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
exclusion of the unaffected part of the uterus out of the treatment field
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
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
Plan to share: Undecided — IPD can be shared. Decision is made upon request.
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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University Hospital, Ghent