Cervical Cancer
Conditions
Keywords
cervical cancer, bulky early-stage, locally advanced, radical hysterectomy, concurrent chemoradiation therapy
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
Interventions
PROCEDURERadical hysterectomy
Piver-Rutledge type III hysterectomy New classification type C2 hysterectomy Open, vaginal, laparoscopic assisted, laparoscopic, robotic radical hysterectomy are all allowed
RADIATIONTailored adjuvant therapy
After radical hysterectomy, intermediate risk group according to GOG protocol 92 criteria will receive adjuvant radiation therapy. High risk group will receive adjuvant chemoradiation therapy with weekly cisplatin (40mg/m2, IV for 6 cycles). Extended filed radiation therapy is allowed in case of common iliac lymph node or para-aortic lymph node metastasis. Intracavitary brachytherapy and nodal or parametrial boost is not allowed.
RADIATIONPrimary chemoradiation therapy
Patient will receive primary radiation therapy including external pelvic irradiation, intracavitary brachytherapy, and parametrial or nodal boost. Extended filed radiation therapy is allowed in case of common iliac lymph node enlargement. Patients will receive concurrent weekly cisplatin (cisplatin 40mg/m2 for 6 cycles) during external radiation therapy.
Sponsors
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 5-year overall survival | 5 year after treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 5-year progression-free survival | 5 years after treatment | — |
| Pattern of disease recurrence | within 5 years afer 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 | — |
Countries
South Korea
Contacts
Primary ContactJoo-Hyun Nam, M.D., Ph.D.
Outcome results
None listed