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Cervical CancerNCT00319462

Localization of Point A in Cervical Cancer

A study testing hemoclip in people with Cervical Cancer, run by Mackay Memorial Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Point A, the major critical point for dose specification of intracavitary brachytherapy, is defined as the crossing of uterine artery and ureter in treatment of cervical cancer. However, the currently advocated systems use hypothetical point A (HPA) to estimate the dosimetry of brachytherapy. Read more about this study

Who is it for?
Ages 30 to 75 years, women only
Conditions the study is for
Cervical Cancer
What is being tested?
hemoclip
Type of treatment
Medical device
How many people
20 participants
Where
1 siteTaiwan
Study dates
Nov 2006to Apr 2007
Phase
Interventional
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 30 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female,
  • Carvical cancer proven by pathology,
  • Indicated for lymph node sampling

Who cannot join

  • Patient refuse lymph node sampling,
  • History of allergy to metal materials

Trial locations and contacts

1 site in 1 country.

Men-Hao Wu, MD contact

886 2 28094661 ext. 2301

Taiwan1 site, 1 recruiting
  • Department of Radiation Oncology

    Taipei, 104

    Kuo-Hwa Chang, MD, 8862 28094661 ext. 2301

    Men-Hao Wu, MD, 886 2 28064661 ext. 2302

    Recruiting

Other trials in Taiwan

About this study

Official title: Localization of Anatomic Point A in Cervical Cancer Patients

Point A, the major critical point for dose specification of intracavitary brachytherapy, is defined as the crossing of uterine artery and ureter in treatment of cervical cancer. However, the currently advocated systems use hypothetical point A (HPA) to estimate the dosimetry of brachytherapy. This study is to localize anatomic point A (APA) of cervical cancer patients for reference of radiotherapy. We will use laparoscopic clipping technique to localize APA for cervical cancer patients during pelvic and paraaortic lymph node sampling. When these patients are receiving brachytherapy, orthogonal radiographs will be obtained after insertion of tandem and colpostats by using Henschke afterloading applicators.

Read the detailed description

Radiation therapy (RT), with a relevant integration of external beam radiotherapy (EBRT) and intracavitary brachytherapy (ICBT), is an important part in the treatment of cervical cancer. Even though concurrent chemoradiation therapy (CCRT) improves the control of locoregional recurrence and distant metastasis for locally advanced disease, the role of RT remains important and essential. ICBT is an essential component of RT and has been used to deliver a high localized dose to the primary cervical lesion and adjacent parametria with an attempt to minimize dose to nearby normal tissues. The conventional point-based dose prescription systems have been applied for decades. Incorporation of modern imaging techniques, namely computerized tomography (CT), magnetic resonance imaging (MRI) and positron emission tomography (PET) to ICBT, enable radiation oncologists to individualize treatment volumes but yet, not applicable for routine practice. Point A, since defined by Tod and Meredith in 1938 and revised in 1953, has been widely accepted as a sacrosanct reference point for dose prescription of ICBT. Point A was defined as a point 2 cm above the cervical os and 2 cm apart from os on the line perpendicular to uterine axis. It is a hypothetical point representing the crossover of the ureter and uterine artery, located in the paracervical triangle, and is considered as a critical point for radiation tolerance. This definition of point A provides an easy way to prescribe dose in ICBT and integrate with EBRT. However, its dosimetry according to orthogonal radiographs would depend solely on the applicator geometry but not the individual tumor volume or location. The International Commission on Radiation Units and Measurements (ICRU) report 38 proposed a set of guidelines for uniform reporting. Reporting of the dimensions of reference volumes still depends on the geometry of applied applicator and remains difficult for reporting of ICBT. Thus, point A is still used as a reference point for dose prescription and for correlating the treatment outcome in clinical trials. CCRT has been considered as a standard of care for locally advanced cervical cancer. To further dissect the patient population, which may have a benefit of less morbidity from CCRT, but not radical surgery plus subsequent RT, the sampling of pelvic and paraaortic lymph nodes prior to decision of intended surgery has been utilized by performing laparoscopy or laparotomy for stages IB and IIA. Moreover, this sampling procedure can also provide a pathological proof and delineation of lymph nodes at risk for an important reference of RT field design. During sampling procedures, we observed that the point crossing over the ureter and uterine artery could be visualized and marked by using hemoclips. Therefore, the anatomic position of point A could be visualized on the orthogonal films after closure of abdominal wound. In this study, we attempt to compare the location of and the radiation doses to anatomic point A (APA) and hypothetical point A (HPA) during fractionated ICBT.

Conditions
Cervical Cancer
Being tested
hemoclip
Keywords
point A, cervical cancer, radiotherapy
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.

  • hemoclipDevice

What is being measured

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

  1. Distance difference between anatomiacal and hypothetical point A

Secondary outcomes (1)
  1. Difference from prescribed dose between anatomiacal and hypothetical point A

Timeline

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

  1. First posted27 Apr 2006 (estimated)
  2. Study startNov 2006
  3. Study completionApr 2007 (estimated)

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 N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00319462
Sponsor's protocol ID
MMH-I-S-260
Status last verified
Apr 2006
First submitted
27 Apr 2006
Last updated
19 Apr 2007
Results posted
No
Data monitoring committee
Yes

Publications

  • Datta NR. From 'points' to 'profiles' in intracavitary brachytherapy of cervical cancer. Curr Opin Obstet Gynecol. 2005 Feb;17(1):35-41. doi: 10.1097/00001703-200502000-00007.

    PubMed 15711409
  • Datta NR, Basu R, Das KJ, Rajasekar D, Pandey CM, Ayyagari S. Problems in reporting doses and volumes during multiple high-dose-rate intracavitary brachytherapy for carcinoma cervix as per ICRU Report 38: a comparative study using flexible and rigid applicators. Gynecol Oncol. 2003 Nov;91(2):285-92. doi: 10.1016/s0090-8258(03)00506-7.

    PubMed 14599857
  • Wang KL, Yang YC, Chao KS, Wu MH, Tai HC, Chen TC, Huang MC, Chen JR, Su TH, Chen YJ. Correlation of traditional point a with anatomic location of uterine artery and ureter in cancer of the uterine cervix. Int J Radiat Oncol Biol Phys. 2007 Oct 1;69(2):498-503. doi: 10.1016/j.ijrobp.2007.03.038.

    PubMed 17869664

Questions about this trial

What is this clinical trial studying?

A study testing hemoclip in people with Cervical Cancer, run by Mackay Memorial Hospital at 1 site in Taiwan.

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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 19 Apr 2007. 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 Taiwan. 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?

Results are not available in the source record.

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

Contact Yu-Jen Chen, MD,PhD (886 2 28094661 ext. 3060, chenmdphd@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Distance difference between anatomiacal and hypothetical point A. 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 NCT00319462, which also lists 3 linked publications.

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 19 Apr 2007.

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