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Localization of Point A in Cervical Cancer

Primary Purpose

Cervical Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
hemoclip
Sponsored by
Mackay Memorial Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cervical Cancer focused on measuring point A, cervical cancer, radiotherapy

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Radiation OncologyRecruiting

Outcomes

Primary Outcome Measures

Distance difference between anatomiacal and hypothetical point A

Secondary Outcome Measures

Difference from prescribed dose between anatomiacal and hypothetical point A

Full Information

First Posted
April 27, 2006
Last Updated
April 18, 2007
Sponsor
Mackay Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00319462
Brief Title
Localization of Point A in Cervical Cancer
Official Title
Localization of Anatomic Point A in Cervical Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2006
Overall Recruitment Status
Unknown status
Study Start Date
November 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Mackay Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
point A, cervical cancer, radiotherapy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
hemoclip
Primary Outcome Measure Information:
Title
Distance difference between anatomiacal and hypothetical point A
Secondary Outcome Measure Information:
Title
Difference from prescribed dose between anatomiacal and hypothetical point A

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu-Jen Chen, MD,PhD
Phone
886 2 28094661
Ext
3060
Email
chenmdphd@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Men-Hao Wu, MD
Phone
886 2 28094661
Ext
2301
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu-Jen Chen, MD,PhD
Organizational Affiliation
Mackay Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Radiation Oncology
City
Taipei
ZIP/Postal Code
104
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kuo-Hwa Chang, MD
Phone
8862 28094661
Ext
2301
First Name & Middle Initial & Last Name & Degree
Men-Hao Wu, MD
Phone
886 2 28064661
Ext
2302

12. IPD Sharing Statement

Citations:
PubMed Identifier
15711409
Citation
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.
Results Reference
background
PubMed Identifier
14599857
Citation
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.
Results Reference
background
PubMed Identifier
17869664
Citation
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.
Results Reference
derived

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Localization of Point A in Cervical Cancer

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