A Randomized Controlled Trial Comparing Radical Hysterectomy Plus Tailored Adjuvant Therapy Versus Primary Chemoradiation Therapy in Bulky Early-stage Cervical Cancer (KGOG 1029)
Radical hysterectomy
+ Tailored adjuvant therapy
+ Primary chemoradiation therapy
Urogenital Diseases+10
+ Genital Diseases
+ Uterine Cervical Diseases
Treatment Study
Summary
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
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.409 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy 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
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