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WithdrawnNCT01514955IMRTUpdated Feb 25, 2016

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

A Phase 1 interventional study of Gold seeds insertion to detect movements at pelvis and Image guided MRI based RT (IMRT+Brachytherapy) in Integrated MRI Based RT as Standard of Care and Locally Advanced Cervical Cancer, sponsored by AHS Cancer Control Alberta. Withdrawn. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-02-25.

Sponsored by AHS Cancer Control Alberta · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Integrated MRI Based RT as Standard of Care
  • Locally Advanced Cervical Cancer
03

In context

Uterine Cervical Neoplasms

1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

AHS Cancer Control Alberta is the lead sponsor of 182 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Enrollment
0 participants (actual)

Interventions

  • RadiationGold seeds insertion to detect movements at pelvis
  • RadiationImage guided MRI based RT (IMRT+Brachytherapy)
06

What researchers measure

Primary outcomes

  1. Feasibility parameters

    Time frame: One year

Secondary outcomes

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

    Time frame: Five years

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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01514955
Lead sponsor
AHS Cancer Control Alberta
Collaborators
Cross Cancer Institute
Responsible party
Sponsor
First posted
Jan 23, 2012
Start date
Nov 2009
Primary completion
Dec 2011
Completion
Dec 2011
Last update
Feb 25, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.

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