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

NCT ID: NCT01514955

Last Updated: 2016-02-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2011-12-31

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.

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.

Conditions

Integrated MRI Based RT as Standard of Care; Locally Advanced Cervical Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT

Interventions

Gold seeds insertion to detect movements at pelvis

Intervention Type: RADIATION

Image guided MRI based RT (IMRT+Brachytherapy)

Intervention Type: RADIATION

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cross Cancer Institute

OTHER

Sponsor Role: collaborator

AHS Cancer Control Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

ACRI PILOT GRANT

Identifier Type: -

Identifier Source: secondary_id

IMRT / 25027

Identifier Type: -

Identifier Source: org_study_id