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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Alberta Health Services
ClinicalTrials.gov Identifier:
NCT01514955
First received: December 8, 2011
Last updated: January 18, 2012
Last verified: January 2012
History of Changes
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alberta Health Services:

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

Secondary Outcome Measures:
  • Response rate, acute and late toxicity, local control rate, survival [ Time Frame: Five years ] [ Designated as safety issue: No ]
  • Dosimetric comparison between 2D and 3D Brachytherapy treatment planning [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: November 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Alberta Health Services
ClinicalTrials.gov Identifier: NCT01514955     History of Changes
Other Study ID Numbers: IMRT / 25027, ACRI PILOT GRANT
Study First Received: December 8, 2011
Last Updated: January 18, 2012
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on May 21, 2013