Locally Advanced Cervical Cancer Clinical Trial
— IMRTOfficial title:
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
Verified date | January 2012 |
Source | AHS Cancer Control Alberta |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Ethics Review Committee |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
AHS Cancer Control Alberta | Cross Cancer Institute |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility parameters | One year | ||
Secondary | Response rate, acute and late toxicity, local control rate, survival | Five years | No | |
Secondary | Dosimetric comparison between 2D and 3D Brachytherapy treatment planning | No |
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