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