AzTrials
AzTrials

Cervical CancerPhase 2NCT00278304

Radiation Therapy in Treating Patients With Cervical Cancer

A Phase 2 study testing brachytherapy and radiation therapy in people with Cervical Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

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

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cervical Cancer
What is being tested?
brachytherapy and radiation therapy
Type of treatment
Surgery or procedure
How many people
20 participants
Where
1 siteUnited States
Study dates
Sep 2005to Jun 2006
Phase
Phase 2
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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed carcinoma of the cervix of 1 of the following cellular subtypes:
  • Squamous cell
  • Adenocarcinoma
  • Adenosquamous cell
  • Stages IB-IVA disease
  • Stage IVB disease allowed provided the impact on the quality of life is tremendous (e.g., "frozen pelvis" or massive pelvic disease and fistula formation, severe pain, or bleeding)
  • Measurable and/or evaluable disease on MRI

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • No physical or physiological capacity that would preclude study treatment
  • No cognitively impaired patients who cannot provide informed consent
  • Not pregnant or nursing
  • Negative pregnancy test
  • No contraindication to MRI, including any of the following:
  • Weight > 136 kg
  • Allergy to MR contrast agent
  • Pacemakers, cerebral aneurysm clips, shrapnel injury, or implantable electronic devices
  • No significant unrelated systemic illness
  • No serious infections
  • No significant cardiac, pulmonary, hepatic, or other organ dysfunction that would preclude study treatment
  • Must be medically fit to receive anesthesia

PRIOR CONCURRENT THERAPY:

  • No prior definitive brachytherapy procedures
  • Ring implants or intravaginal cones for the relief of excessive bleeding allowed
  • No prior definitive surgical oncologic procedures (e.g., radical hysterectomy)
  • Concurrent chemotherapy, immunotherapy, or hormonal therapy allowed

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

    Bethesda, Maryland, 20892-1182

Other trials in United States

About this study

Official title: A Pilot Study of MR-Guided High Dose Rate Brachytherapy With MR Image Acquisition for Patients With Cervical Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving external-beam radiation together with internal radiation works in treating patients with cervical cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the feasibility of magnetic resonance-guided, endocavitary, high-dose rate brachytherapy implants in patients with stage IB-IVB cervical cancer.
  • Provide more reliable dose-volume estimations based on three-dimensional imaging-based treatment planning in patients treated with this regimen.

Secondary

  • Determine the toxic effects and treatment tolerance in patients treated with this regimen.
  • Correlate three-dimensional dose-volume histograms of organs at risk with treatment toxicity in patients treated with this regimen.
  • Determine the disease status, time and patterns of relapse, and survival of patients treated with this regimen.

OUTLINE: Patients undergo external beam radiotherapy 4-5 days a week for up to 7 weeks. Patients also undergo MRI-guided high-dose brachytherapy comprising one brachytherapy implant a week for 3-6 implants. Brachytherapy may be administered during or after external beam radiotherapy.

After completion of study treatment, patients are followed periodically for 5 years.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Conditions
Cervical Cancer
Being tested
brachytherapy, radiation therapy
Keywords
cervical adenocarcinoma, cervical adenosquamous cell carcinoma, cervical squamous cell carcinoma, stage IB cervical cancer, stage IIA cervical cancer, stage IIB cervical cancer, stage III cervical cancer, stage IVA cervical cancer, stage IVB cervical cancer
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.

  • brachytherapyRadiation

  • radiation therapyRadiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility

  2. Comparison of dose-volume estimations based on 3D imaging-based treatment planning, with the traditional point dose method based on orthogonal radiographs

Secondary outcomes (6)

  1. Tolerance

  2. Toxicity

  3. Correlate three-dimensional dose-volume histograms of organs at risk with treatment toxicity

  4. Disease status

  5. Time and patterns of relapse

  6. Survival distributions

Timeline

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

  1. First posted18 Jan 2006 (estimated)
  2. Study startSep 2005
  3. Study completionJun 2006

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00278304
Sponsor's protocol ID
CDR0000454997
Other IDs
NCI-05-C-0233
Status last verified
Apr 2006
First submitted
16 Jan 2006
Last updated
20 Jun 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing brachytherapy and radiation therapy in people with Cervical Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

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

Who may be eligible to take part?

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 20 Jun 2013. 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 United States. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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.

What does the primary outcome measure?

Feasibility. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00278304.

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 20 Jun 2013.

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