An Initial Feasibility Study to Integrate MRI Based Brachytherapy and CT/MR Fused INRT in Treatment of Advance Cervical Cancer

Study Overview
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Brief Summary
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Main cause of mortality in cervix cancer is local relapse in the pelvis. Since distant metastasis is quiet rare, increasing local control in the pelvis can directly translate into improvement in survival. Obstacles in front of this approach is the dose limitation to normal organs located in the pelvis adjacent to the tumor. 3-D MRI based EBRT and Brachytherapy will grant safe delivery of more conformal higher doses of radiation to the tumor and allowing sparing of the normal structures.

Detailed Description
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A total of 10 patients with a diagnosis of locally advanced cervical carcinoma will be enrolled. After diagnosis and written informed consent, patients will undergo investigations prior to treatment planning, including CT imaging as per standard of care. In addition, patients will have an MRI of the pelvis + PET scan + EUA and gold seeds insertion to verify pelvic organs movement and EB-IMRT with daily cone beam CT. Brachytherapy treatment planning will be based on MRI imaging with the applicator in situ.

Official Title
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An Initial Feasibility Study to Integrate High-precision, Image Guided, Radiotherapy(MRI Based Brachytherapy and CT/MRI Fused Dynamic IMRT Planning) in the Treatment Planning of 10 Patients With Locally Advanced Carcinoma of the Cervix

Conditions
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Integrated MRI Based RT as Standard of Care, Locally Advanced Cervical Cancer

Intervention / Treatment
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* Radiation: Gold seeds insertion to detect movements at pelvis
* Radiation: Image guided MRI based RT (IMRT+Brachytherapy)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cancer of the uterine cervix considered suitable for curative treatment with definitive radio-chemo-therapy including MRI guided BT. (stage IB2 bulky disease-stage IVa) Staging according to FIGO and TNM guidelines Positive biopsy showing squamous cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma of the uterine cervix No pelvic nodes > 2cm MRI of pelvis at diagnosis MRI of the retroperitoneal space and abdomen at diagnosis MRI with applicator in place at time of BT Age 18-70 years Patient informed consent Exclusion Criteria: Pelvic nodes > 2cm Previous pelvic or abdominal radiotherapy Previous total or partial hysterectomy Combination of preoperative radiotherapy with surgery Patients receiving neo-adjuvant chemotherapy Patients receiving BT only Contraindications to MRI

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: Gold seeds insertion to detect movements at pelvis|nan|
|Radiation: Image guided MRI based RT (IMRT+Brachytherapy)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility parameters |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate, acute and late toxicity, local control rate, survival |  | Five years | 
| Dosimetric comparison between 2D and 3D Brachytherapy treatment planning |  |  |