Radical Hysterectomy Followed by Tailored Adjuvant Therapy Versus Primary Chemoradiation Therapy in Bulky Early-stage Cervical Cancer (KGOG 1029)

Study Overview
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Brief Summary
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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

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

Conditions
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Cervical Cancer

Intervention / Treatment
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* Procedure: Radical hysterectomy
* Radiation: Tailored adjuvant therapy
* Radiation: Primary chemoradiation therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RH group<br>Radical hysterectomy followed by tailored adjuvant therapy | Procedure: Radical hysterectomy<br>* Piver-Rutledge type III hysterectomy New classification type C2 hysterectomy Open, vaginal, laparoscopic assisted, laparoscopic, robotic radical hysterectomy are all allowed<br>Radiation: Tailored adjuvant therapy<br>* 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.<br>* Other names: Adjuvant chemoradiation therapy;|
| Active Comparator: CCRT group<br>Primary concurrent chemoradiation therapy | Radiation: Primary chemoradiation therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-year overall survival |  | 5 year after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-year progression-free survival |  | 5 years after treatment | 
| Pattern of disease recurrence |  | within 5 years afer treatment | 
| Treatment-related toxicity | Treatment related toxicity will be evaluated using CTCAE v3.0. | within 5 years after treatment | 
| Quality of life |  | within 1 year after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical cancer, bulky early-stage, locally advanced, radical hysterectomy, concurrent chemoradiation therapy