This study is a prospective, multicenter and randomized clinical trial (DEBULK trial) to determine the therapeutic effect of surgical debulking of bulky or multiple lymph nodes before concurrent chemoradiation therapy (CCRT) in cervical cancer stage IIICr.
Bulky or multiple lymph nodes metastasis in cervical cancer shows poor prognosis and can also diminish the effect of radiotherapy or concurrent chemoradiation therapy (CCRT). However, it is difficult to increase the dose of radiation and chemotherapy considering their side effects. Therefore, the objective of this study is to determine the therapeutic effect of surgical debulking of bulky or multiple lymph nodes before concurrent chemoradiation therapy (CCRT) compared to CCRT only, in cervical cancer stage IIICr. This study is a phase III, multicenter and randomized clinical trial (DEBULK trial). * Concurrent chemoradiation therapy (CCRT) * Surgical debulking of bulky or multiple lymph node followed by CCRT
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
240
CCRT
Surgical debulking of lymph nodes + CCRT
PFS
Progression-free survival
Time frame: 3 years
OS
Overall survival
Time frame: 3 years
Treatment-related complications
Treatment-related complications
Time frame: 3 years
False positive rate & positive predictive value of bulky or multiple LN imaging
To determine the accuracy of LN metastasis in imaging study
Time frame: 6 months
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Aster CMI Hospital
Bengaluru, India
NOT_YET_RECRUITINGFondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy
NOT_YET_RECRUITINGFirst Obstetrics and Gynecology Clinic, "G. E. Palade" University of Medicine, Pharmacy, Science and Technology
Târgu Mureş, Romania
NOT_YET_RECRUITINGSoon Chun Hyang University Hospital Cheonan
Cheonan, Chungcheongnam-do, South Korea
RECRUITINGKorea University Ansan Hospital
Ansan-si, Gyeonggi-do, South Korea
RECRUITINGDongguk University Medical Center
Goyang-si, Gyeonggi-do, South Korea
RECRUITINGNational Cancer Center
Goyang-si, Gyeonggi-do, South Korea
RECRUITINGCHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggi-do, South Korea
RECRUITINGPusan National University Yangsan Hospital
Yangsan, Gyeongsangbuk-do, South Korea
RECRUITINGSamsung Changwon Medical Center
Changwon, Gyeongsangnam-do, South Korea
RECRUITING...and 16 more locations