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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RH group | Experimental | Radical hysterectomy followed by tailored adjuvant therapy |
|
| CCRT group | Active Comparator | Primary concurrent chemoradiation therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radical hysterectomy | Procedure | Piver-Rutledge type III hysterectomy New classification type C2 hysterectomy Open, vaginal, laparoscopic assisted, laparoscopic, robotic radical hysterectomy are all allowed |
| Measure | Description | Time Frame |
|---|---|---|
| 5-year overall survival | 5 year after treatment |
| 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 |
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Inclusion Criteria:
Previously untreated, histologically confirmed cervical cancer
FIGO stage IB2 and IIA2 disease
One of following histologic types
Gynecologic Oncology Group performance status: 0-2
Adequate organ function
Patient who have Singed an approved informed consent
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joo-Hyun Nam, M.D., Ph.D. | Contact | 82-2-3010-3633 | jhnam@amc.seoul.kr |
| Name | Affiliation | Role |
|---|---|---|
| Joo-Hyun Nam, M.D., Ph.D. | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center | Recruiting | Seoul | 138-736 | South Korea |
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| Tailored adjuvant therapy | Radiation | 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. |
|
|
| Primary chemoradiation therapy | Radiation | 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. |
|
Treatment related toxicity will be evaluated using CTCAE v3.0. |
| within 5 years after treatment |
| Quality of life | within 1 year after treatment |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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