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Radical Hysterectomy Followed by Tailored Adjuvant Therapy Versus Primary Chemoradiation Therapy in Bulky Early-stage Cervical Cancer (KGOG 1029)
Conditions
Cervical Cancer
Conditions: official terms
Uterine Cervical Neoplasms
Conditions: Keywords
cervical cancer, bulky early-stage, locally advanced, radical hysterectomy, concurrent chemoradiation therapy
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Radical hysterectomy
Type: Procedure
Name: Tailored adjuvant therapy
Type: Radiation
Name: Primary chemoradiation therapy
Type: Radiation
Overall Status
Recruiting
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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 20 Years
Gender: Female
Criteria: Inclusion Criteria:
- Previously untreated, histologically confirmed cervical cancer
- FIGO stage IB2 and IIA2 disease
- One of following histologic types
1. Squamous cell carcinoma
2. Adenocarcinoma
3. Adenosquamous carcinoma
- Gynecologic Oncology Group performance status: 0-2
- Adequate organ function
1. Bone marrow: WBC > 3000/mm3, ANC ≥ 1,000/mm3, Platelet ≥ 100*103/mm3, Hemoglobin ≥ 10g/dL
2. Kidney: Creatine < 1.25 * upper normal limit
3. 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
- Previously untreated, histologically confirmed cervical cancer
- FIGO stage IB2 and IIA2 disease
- One of following histologic types
1. Squamous cell carcinoma
2. Adenocarcinoma
3. Adenosquamous carcinoma
- Gynecologic Oncology Group performance status: 0-2
- Adequate organ function
1. Bone marrow: WBC > 3000/mm3, ANC ≥ 1,000/mm3, Platelet ≥ 100*103/mm3, Hemoglobin ≥ 10g/dL
2. Kidney: Creatine < 1.25 * upper normal limit
3. 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
Location
Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
Seoul, Korea, Republic of
Status: Recruiting
Contact: Joo-Hyun Nam, M.D., Ph.D. - 82-2-3010-3633 - jhnam@amc.seoul.kr
Start Date
September 2012
Sponsors
Asan Medical Center
Source
Asan Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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