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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)

Primary Purpose

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

Status

Withdrawn

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Gold seeds insertion to detect movements at pelvis

Image guided MRI based RT (IMRT+Brachytherapy)

About this trial

This is an interventional treatment trial for Integrated MRI Based RT as Standard of Care

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Feasibility parameters

Secondary Outcome Measures

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

Dosimetric comparison between 2D and 3D Brachytherapy treatment planning

Full Information

NCT ID

NCT01514955

First Posted

December 8, 2011

Last Updated

February 24, 2016

Sponsor

AHS Cancer Control Alberta

Collaborators

Cross Cancer Institute

1. Study Identification

Unique Protocol Identification Number

NCT01514955

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Withdrawn

Study Start Date

November 2009 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AHS Cancer Control Alberta

Collaborators

Cross Cancer Institute

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Radiation

Intervention Name(s)

Gold seeds insertion to detect movements at pelvis

Intervention Type

Radiation

Intervention Name(s)

Image guided MRI based RT (IMRT+Brachytherapy)

Primary Outcome Measure Information:

Title

Feasibility parameters

Time Frame

One year

Secondary Outcome Measure Information:

Title

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

Time Frame

Five years

Title

Dosimetric comparison between 2D and 3D Brachytherapy treatment planning

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

12. IPD Sharing Statement

Learn more about this trial

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

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