Localization of Point A in Cervical Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2006 by Mackay Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Mackay Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00319462
First received: April 27, 2006
Last updated: April 18, 2007
Last verified: April 2006
  Purpose

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.


Condition Intervention
Cervical Cancer
Device: hemoclip

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Localization of Anatomic Point A in Cervical Cancer Patients

Resource links provided by NLM:


Further study details as provided by Mackay Memorial Hospital:

Primary Outcome Measures:
  • Distance difference between anatomiacal and hypothetical point A

Secondary Outcome Measures:
  • Difference from prescribed dose between anatomiacal and hypothetical point A

Estimated Enrollment: 20
Study Start Date: November 2006
Estimated Study Completion Date: April 2007
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.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patient refuse lymph node sampling,
  • History of allergy to metal materials
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00319462

Contacts
Contact: Yu-Jen Chen, MD,PhD 886 2 28094661 ext 3060 chenmdphd@yahoo.com
Contact: Men-Hao Wu, MD 886 2 28094661 ext 2301

Locations
Taiwan
Department of Radiation Oncology Recruiting
Taipei, Taiwan, 104
Contact: Kuo-Hwa Chang, MD    8862 28094661 ext 2301      
Contact: Men-Hao Wu, MD    886 2 28064661 ext 2302      
Sponsors and Collaborators
Mackay Memorial Hospital
Investigators
Principal Investigator: Yu-Jen Chen, MD,PhD Mackay Memorial Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00319462     History of Changes
Other Study ID Numbers: MMH-I-S-260
Study First Received: April 27, 2006
Last Updated: April 18, 2007
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Mackay Memorial Hospital:
point A, cervical cancer, radiotherapy

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 16, 2014