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

Locally Advanced Cervical Cancer Clinical Trial

— IMRT  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01514955
• Other study ID #: IMRT / 25027
• Secondary ID: ACRI PILOT GRANT
• Status: Withdrawn
• Phase: Phase 1
• First received: December 8, 2011
• Last updated: February 24, 2016
• Start date: November 2009
• Est. completion date: December 2011

Study information

• 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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Integrated MRI Based RT as Standard of Care
• Locally Advanced Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Radiation:
• Gold seeds insertion to detect movements at pelvis

• Image guided MRI based RT (IMRT+Brachytherapy)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
AHS Cancer Control Alberta	Cross Cancer Institute

Outcome

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