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Cervix CancerNCT00124423

Megavoltage CT (MVCT) Imaging for Intracavitary Radiation Treatment in Cervix Cancer

An observational study of Cervix Cancer, run by AHS Cancer Control Alberta at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The Cross Cancer Institute has recently acquired a tomotherapy radiotherapy treatment machine; the first of its kind in Canada. It has the potential to improve cancer treatment outcomes where radiotherapy is used. Cervix cancer is a disease where radiotherapy is a particularly important treatment modality. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Cervix Cancer
What is being tested?
Megavoltage CT scan
Type of treatment
Surgery or procedure
How many people
5 participants
Where
1 siteCanada
Study dates
Jun 2004to Jun 2007
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: community sample

Who may be able to join

  • Patients undergoing brachytherapy for cervix cancer

Who cannot join

  • Patient refusal

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

Other trials in Canada

About this study

The Cross Cancer Institute has recently acquired a tomotherapy radiotherapy treatment machine; the first of its kind in Canada. It has the potential to improve cancer treatment outcomes where radiotherapy is used. Cervix cancer is a disease where radiotherapy is a particularly important treatment modality. The researchers believe that by combining tomotherapy (which has the ability to give higher doses of radiation to areas of cancer while sparing normal tissues) with radiotherapy given from inside the uterus and vagina (brachytherapy) disease outcomes will be improved. For this to be possible the researchers will need to accurately map the doses of radiation given to the cervix, uterus and other pelvic organs from these two types of radiation treatment. As well as being used for treatment, the tomotherapy machine can also be used for taking medical images by using very much lower doses of radiation. This study will allow the researchers to develop the mapping process by using very low doses of radiation on the tomotherapy unit to take medical x-ray images of patients being treated by brachytherapy for cervix cancer. In this special circumstance the researchers expect the images to be of a higher quality than for conventional computed tomography (CT) scanning or magnetic resonance imaging (MRI) scanning.

Read the detailed description

Megavoltage CT Imaging for Intracavitary Radiation Treatment in Cervix Cancer

Proposal

To assess the feasibility of performing CT imaging using a megavoltage CT scanner on five patients where remote afterloading intracavitary applicators have been inserted for the purpose of delivering intracavitary radiotherapy in the treatment of cervix cancer.

Rationale

While there has been recent improvements in the treatment of more advanced stages of cervix cancer by combining radical radiation treatment with concurrent cisplatin based chemotherapy, there is room for further improvements in local regional control. One approach to achieving this is to increase the dose of therapeutic radiation to the clinical target volume without exceeding the tolerance of the adjacent normal tissues. Modern radiotherapy techniques allow for better conformation of the high dose radiation volume to the clinical target volume by using external beam techniques (conformal radiation treatment and intensity modulated radiation treatment) and the use of tomotherapy is likely to be particularly advantageous in this regard. The mainstay of cervix cancer radiotherapy has always been and will likely remain the use of brachytherapy. Future improvements in the outcome of cervix cancer treated by radiotherapy are therefore likely to necessitate accurately combining intracavitary radiation treatment with intensity modulated external beam radiation treatment and particularly with the use of tomotherapy techniques.

The ability to accurately reconstruct the three-dimensional dosimetry achieved by the combined use of intracavitary radiation treatment and helical tomotherapy will be pivotal in the success of this strategy. Conventional CT imaging of patients receiving intracavitary radiation treatment is hampered by distortion artifacts from the metallic applicators. The opportunity to gain improved images using megavoltage CT scanning using the same equipment and same patient set-up that will ultimately by used for the delivery of tomotherapy offers some unique potential advantages and solutions to the problem.

By imaging patients with the remote afterloading applications in situ, the researchers should be able to generate accurate isodose distributions in three dimensions for the intracavitary component of the cervix cancer treatment. By contouring the clinical target volume, which includes the primary cancer, local routes of spread and regional pelvic lymph nodes, the researchers can explore the feasibility of generating combined helical tomotherapy and intracavitary radiation treatment plans.

Patients and Methods

Patients who are to receive intracavitary brachytherapy on the low dose rate selectron at the Cross Cancer Institute will be approached to participate in this pilot study. An informed consent will be obtained from five patients for this study. Following the insertion of the remote afterloading applicators in the operating room, patients are normally transferred from the operating room to Simulator C for orthogonal simulator films and then to Station 30 where treatment is started approximately two hours later after dosimetry calculations have been performed and treatment has been prescribed.

For the patients consenting to this study, they will proceed from Simulator C to Station 30 via the tomotherapy unit in CBIAR where megavoltage CT scans will be taken. Patients will be accompanied by a brachytherapy radiation therapist. The megavoltage CT scans will take approximately one hour to perform, but this will not result in any treatment delay for the patient.

Isodose volumes from the prescribed intracavitary brachytherapy will be reconstructed on the megavoltage images. The feasibility of defining the clinical target volume on the megavoltage scans will be explored. This may require fusion with conventional CT images that will already have been taken for diagnostic and external beam treatment planning purposes. Megavoltage and/or fused images will be used to pilot the integration of tomotherapy intensity modulated radiation therapy treatment plans with intracavitary brachytherapy dosimetry.

The current study will have no influence on individual patient treatments but is a prelude to a potential dose escalation study using tomotherapy for patients with cervix cancer.

Conditions
Cervix Cancer
Being tested
Megavoltage CT scan
Keywords
brachytherapy megavoltage CT imaging
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Megavoltage CT scanProcedure or surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2005 (estimated)
  2. Study startJun 2004
  3. Primary completionJun 2007
  4. Study completionJun 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00124423
Sponsor's protocol ID
GY-03-0018/ethics 21373
Status last verified
Apr 2012
First submitted
26 Jul 2005
Last updated
26 Feb 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cervix Cancer, run by AHS Cancer Control Alberta at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2016.

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