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Clinical Trial Details — Status: Withdrawn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Status Withdrawn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Status Withdrawn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


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
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