Suspended

A Randomized Controlled Trial Comparing Radical Hysterectomy Plus Tailored Adjuvant Therapy Versus Primary Chemoradiation Therapy in Bulky Early-stage Cervical Cancer (KGOG 1029)

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Radical hysterectomy

+ Tailored adjuvant therapy

+ Primary chemoradiation therapy

ProcedureRadiation
Who is being recruted

Urogenital Diseases+10

+ Genital Diseases

+ Uterine Cervical Diseases

From 20 to 75 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: September 2012
See protocol details

Summary

Principal SponsorAsan Medical Center
Study ContactJoo-Hyun Nam, M.D., Ph.D.More contacts
Last updated: May 31, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

To compare 5-year overall survival between patients who undergo radical hysterectomy followed by tailored adjuvant therapy and patients who receive primary chemoradiation therapy in FIGO stage IB2 and IIA2 cervical cancer

Principal SponsorAsan Medical Center
Study ContactJoo-Hyun Nam, M.D., Ph.D.More contacts
Last updated: May 31, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

409 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 20 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesUterine Cervical DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Neoplasms, FemaleNeoplasmsNeoplasms by SiteUrogenital NeoplasmsUterine DiseasesUterine NeoplasmsFemale Urogenital DiseasesUterine Cervical Neoplasms

Criteria

Inclusion Criteria: Previously untreated, histologically confirmed cervical cancer FIGO stage IB2 and IIA2 disease One of following histologic types Squamous cell carcinoma Adenocarcinoma Adenosquamous carcinoma Gynecologic Oncology Group performance status: 0-2 Adequate organ function Bone marrow: WBC > 3000/mm3, ANC ≥ 1,000/mm3, Platelet ≥ 100*103/mm3, Hemoglobin ≥ 10g/dL Kidney: Creatine < 1.25 * upper normal limit Liver: AST, ANT < 3 * upper normal limit, Total bilirubin < 1.5 mg/mm3 Patient who have Singed an approved informed consent Exclusion Criteria: Patients with cervical cancer who have received any previous radiation or chemotherapy Neuroendocrine carcinoma of uterine cervix Occult cervical cancer which was found after simple hysterectomy Para-aortic nodal involvement (> 10 mm short axis diameter on pretreatment imaging study) History of other invasive malignancies, with the exception of non-melanoma skin cancer, in situ melanoma and thyroid cancer, who had (or have) no evidence of the other cancer present within the last 5 years Serious illness or medical condition that precludes the safe administration of the trial treatment including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Prior diagnosis of Crohn's disease or ulcerative colitis Neurologic or psychiatric disease Patients who are pregnant or lactating

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Radical hysterectomy followed by tailored adjuvant therapy

Group II

Active Comparator
Primary concurrent chemoradiation therapy

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center

Seoul, South KoreaOpen Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center in Google Maps
SuspendedOne Study Center