Radical Hysterectomy Followed by Tailored Adjuvant Therapy Versus Primary Chemoradiation Therapy in Bulky Early-stage Cervical Cancer (KGOG 1029)
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|ClinicalTrials.gov Identifier: NCT01680523|
Recruitment Status : Unknown
Verified May 2017 by Joo-Hyun Nam, Asan Medical Center.
Recruitment status was: Recruiting
First Posted : September 7, 2012
Last Update Posted : May 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer||Procedure: Radical hysterectomy Radiation: Tailored adjuvant therapy Radiation: Primary chemoradiation therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||409 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Controlled Trial Comparing Radical Hysterectomy Plus Tailored Adjuvant Therapy Versus Primary Chemoradiation Therapy in Bulky Early-stage Cervical Cancer (KGOG 1029)|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2020|
Experimental: RH group
Radical hysterectomy followed by tailored adjuvant therapy
Procedure: Radical hysterectomy
Piver-Rutledge type III hysterectomy New classification type C2 hysterectomy Open, vaginal, laparoscopic assisted, laparoscopic, robotic radical hysterectomy are all allowed
Radiation: Tailored 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.
Active Comparator: CCRT group
Primary concurrent chemoradiation therapy
Radiation: Primary 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.
- 5-year overall survival [ Time Frame: 5 year after treatment ]
- 5-year progression-free survival [ Time Frame: 5 years after treatment ]
- Pattern of disease recurrence [ Time Frame: within 5 years afer treatment ]
- Treatment-related toxicity [ Time Frame: within 5 years after treatment ]Treatment related toxicity will be evaluated using CTCAE v3.0.
- Quality of life [ Time Frame: within 1 year after treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01680523
|Contact: Joo-Hyun Nam, M.D., Ph.D.||firstname.lastname@example.org|
|Korea, Republic of|
|Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center||Recruiting|
|Seoul, Korea, Republic of, 138-736|
|Contact: Joo-Hyun Nam, M.D., Ph.D. 82-2-3010-3633 email@example.com|
|Principal Investigator:||Joo-Hyun Nam, M.D., Ph.D.||Asan Medical Center|