Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00319462
Status:
UNKNOWN
Last Update Posted:
2007-04-19
First Post:
2006-04-27
Brief Title:
Localization of Point A in Cervical Cancer
Sponsor:
Mackay Memorial Hospital
Organization:
Mackay Memorial Hospital
Study Overview
Official Title:
Localization of Anatomic Point A in Cervical Cancer Patients
Status:
UNKNOWN
Status Verified Date:
2006-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None