NCT00319462

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2006

Completed
Same day until next milestone

First Posted

Study publicly available on registry

April 27, 2006

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

April 19, 2007

Status Verified

April 1, 2006

First QC Date

April 27, 2006

Last Update Submit

April 18, 2007

Conditions

Keywords

point A, cervical cancer, radiotherapy

Outcome Measures

Primary Outcomes (1)

  • Distance difference between anatomiacal and hypothetical point A

Secondary Outcomes (1)

  • Difference from prescribed dose between anatomiacal and hypothetical point A

Interventions

hemoclipDEVICE

Eligibility Criteria

Age30 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Radiation Oncology

Taipei, 104, Taiwan

RECRUITING

Related Publications (3)

  • 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.

    PMID: 15711409BACKGROUND
  • 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.

    PMID: 14599857BACKGROUND
  • 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.

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Yu-Jen Chen, MD,PhD

    Mackay Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu-Jen Chen, MD,PhD

CONTACT

Men-Hao Wu, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 27, 2006

First Posted

April 27, 2006

Study Start

November 1, 2006

Study Completion

April 1, 2007

Last Updated

April 19, 2007

Record last verified: 2006-04

Locations