Randomized comparison of neoadjuvant chemotherapy followed by radical hysterectomy with pelvic ± para-aortic lymphonodectomy (LNE) versus primary cisplatin-based chemo-radiation in patients with cervical cancer FIGO IB2 and IIB.
The optimal treatment for patients with cervical cancer on FIGO stage IB2 and IIB is controversial. There is no randomized comparison of a dose-dense NACT (TP or TIP-schedule) followed by hysterectomy and LNE (investigational Arm A) versus primary chemo-radiation (standard arm B). Primary endpoint is the DFS at 5 years, secondary endpoints local control at 5 years, OS at 5 years, QOL, questionnaires on sexual activity/QOL.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
534
disease free survival
DFS
Time frame: 5 years
overall survival
Time frame: 5 years
local control
local control rate at 5 years
Time frame: 5 years
quality of life
Qol questionnaire EORTC Qol C30 and Cervical Cancer Module EORTC QLQ-CX24
Time frame: 5 years
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