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

NCT01514955 | Withdrawn Phase 1

• 2 other identifiers: IMRT / 25027ACRI PILOT GRANT
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Feasibility parameters

  One year

Secondary Outcomes (2)

• Response rate, acute and late toxicity, local control rate, survival

  Five years

• Dosimetric comparison between 2D and 3D Brachytherapy treatment planning

Interventions

Gold seeds insertion to detect movements at pelvis RADIATION

Image guided MRI based RT (IMRT+Brachytherapy) RADIATION

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead
• Cross Cancer Institute: collaborator

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2011
• First Posted: January 23, 2012
• Study Start: November 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: February 25, 2016

Record last verified: 2012-01