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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01514955
Recruitment Status : Withdrawn
First Posted : January 23, 2012
Last Update Posted : February 25, 2016
Cross Cancer Institute
Information provided by (Responsible Party):
AHS Cancer Control Alberta

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Integrated MRI Based RT as Standard of Care Locally Advanced Cervical Cancer Radiation: Gold seeds insertion to detect movements at pelvis Radiation: Image guided MRI based RT (IMRT+Brachytherapy) Phase 1

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Official 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
Study Start Date : November 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. Feasibility parameters [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Response rate, acute and late toxicity, local control rate, survival [ Time Frame: Five years ]
  2. Dosimetric comparison between 2D and 3D Brachytherapy treatment planning

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Responsible Party: AHS Cancer Control Alberta Identifier: NCT01514955     History of Changes
Other Study ID Numbers: IMRT / 25027
First Posted: January 23, 2012    Key Record Dates
Last Update Posted: February 25, 2016
Last Verified: January 2012

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female