Radical Hysterectomy Followed by Tailored Adjuvant Therapy Versus Primary Chemoradiation Therapy in Bulky Early-stage Cervical Cancer (KGOG 1029)
- Conditions
- Cervical Cancer
- Registration Number
- NCT01680523
- Lead Sponsor
- Asan Medical Center
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 409
-
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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 5-year overall survival 5 year after treatment
- Secondary Outcome Measures
Name Time Method Pattern of disease recurrence within 5 years afer treatment 5-year progression-free survival 5 years after treatment Treatment-related toxicity within 5 years after treatment Treatment related toxicity will be evaluated using CTCAE v3.0.
Quality of life within 1 year after treatment
Related Research Topics
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Trial Locations
- Locations (1)
Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center🇰🇷Seoul, Korea, Republic ofJoo-Hyun Nam, M.D., Ph.D.Contact82-2-3010-3633jhnam@amc.seoul.kr