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
18 Years
70 Years
Female
Integrated MRI Based RT as Standard of Care, Locally Advanced Cervical Cancer
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Primary Purpose: Treatment
Outcome Measure:
Feasibility parameters
Outcome Time Frame:
One year
Authority:
Canada: Ethics Review Committee
Study ID:
IMRT / 25027
NCT ID:
NCT01514955
Start Date:
November 2009
Completion Date:
December 2011
Related Keywords:
- Integrated MRI Based RT as Standard of Care
- Locally Advanced Cervical Cancer
- Uterine Cervical Neoplasms
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