Exclusion of Non-involved Uterus From the Target Volume in Locally Advanced Cervical Cancer (EXIT)
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|ClinicalTrials.gov Identifier: NCT03542942|
Recruitment Status : Recruiting
First Posted : May 31, 2018
Last Update Posted : May 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Uterine Cervical Neoplasms||Other: treatment with EXIT-target volume||Not Applicable|
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:
- Reducing the dose on OARs by omitting iconographical non tumor-bearing parts of the uterus from the Clinical Target Volume (CTV).
- Performing a dose-escalation to those regions within the gross target volume (GTV) pointed out by Diffusion Weighted Magnetic Resonance Imaging (DW-MRI) to be at risk for treatment failure.
To objectivize our hypotheses, we aim at:
- Demonstrating that omitting iconographical unaffected uterus from the treatment volume leaves no tumor behind in the non-targeted parts of the uterus, leads to lower doses to the OARs and decreases (acute) toxicity.
- Validating that a high baseline apparent diffusion coefficient (ADC) and an increase in ADC 2 weeks after start of CRT, for the whole tumor as well as for intra-tumoral regions, is prognostic for residual tumor on hysterectomy specimen and to consider the possibility for a further dose-escalation on tumors/intratumoral regions at risk for treatment failure.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||March 30, 2016|
|Estimated Primary Completion Date :||December 30, 2018|
|Estimated Study Completion Date :||December 30, 2020|
treatment with EXIT-target volume
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 [ Time Frame: within 3 months after last inclusion ]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
- dosimetry [ Time Frame: within 3 months after last inclusion ]dosimetric comparison of dose on the OARs when comparing study treatment plans compared to treatment of the whole uterus at high doses
- number of participants with treatment-related adverse events as assessed by the radiotherapy oncology group toxicity criteria and CTCAEv4.0 for hematology [ Time Frame: during treatment. 10 days, 1 months and 3 months after ending treatment ]evaluation of acute toxicity, grade 0 (no toxicity) to grade 5 (treatment related death).
- number of participants with treatment-related adverse events as assessed by the radiotherapy oncology group toxicity criteria and CTCAEv4.0 [ Time Frame: 6, 12, 18 and 24 months after treatment. ]evaluation chronic toxicity, grade 0 (no toxicity) to grade 5 (treatment related death).
- local, regional and distant control [ Time Frame: 1, 3, 6, 12,18 and 24 months after treatment ]defined as absence of disease at the primary tumor bed, the regional lymph nodes and distant sites
- Correlation of high-Risk regions on IMaging (DW-MRI) with Pathology and regression pattern analysis (CRIMP). [ Time Frame: Within 6 months after surgery of the last patient ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03542942
|Contact: Katrien Vandecasteele, MD, PhDfirstname.lastname@example.org|
|Contact: Wilfried De Neve, MD, PhDemail@example.com|
|Principal Investigator:||Katrien Vandecasteele, MD, PhD||University Hospital, Ghent|