OncoMatch/Clinical Trials/NCT04733820
Clinical Efficacy of Adjuvant Chemotherapy in Patients With Locally Advanced Cervical Cancer Who Did Not Meet the NCCN Guidelines for Adjuvant Treatment After NACT Combined With Surgery
Is NCT04733820 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Adjuvant chemotherapy for uterine cervical neoplasms.
Treatment: Adjuvant chemotherapy — This is a prospective, phase 3 randomized controlled clinical trial. Cervical cancer patients with FIGO stage IB3, Ⅱ A2 or IIB with tumor size\> 4 cm will be enrolled. Patients will undergo 2-3 cycles of neoadjuvant chemotherapyradical (NACT) followed by laparotomic or laparoscopic hysterectomy + pelvic lymphadenectomy with cervical cancer foci sealed before dissection of the vagina and without uterine manipulator. Patients meet criteria of adjuvant therapy according to NCCN guideline after surgery will be weeded out, and who do not meet criteria of adjuvant therapy will be randomly selected to undergo adjuvant chemotherapy or just follow-up visit. The primary endpoint was disease-free survival (DFS) rate at 5 year. The secondary endpoints were 5-year overall survival (OS), safety and quality of life.
Check if I qualifyExtracted eligibility criteria
Cancer type
Cervical Cancer
Disease stage
Required: Stage IIA, IIB (FIGO 2018)
Clinical stage IB3-IIB cervical cancer (FIGO, 2018 standard) with the tumor diameter > 4cm before treatment.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: neoadjuvant chemotherapy — preoperative
After 2-3 cycles of neoadjuvant chemotherapy, patients do not undergo laparotomic or laparoscopic extensive hysterectomy + pelvic lymph node dissection with cervical cancer foci sealed before dissection of the vagina and without uterine manipulator.
Must have received: extensive hysterectomy + pelvic lymph node dissection — post-neoadjuvant chemotherapy
patients do not undergo laparotomic or laparoscopic extensive hysterectomy + pelvic lymph node dissection with cervical cancer foci sealed before dissection of the vagina and without uterine manipulator.
Cannot have received: neoadjuvant chemotherapy regimen different from postoperative adjuvant therapy regimen
Neoadjuvant chemotherapy regimens are different from postoperative adjuvant therapy regimens.
Lab requirements
Blood counts
wbc≥3.5*10^9/l, neu≥1.5*10^9/l, platelet≥80×10^9 /l
Kidney function
serum creatinine and blood urea nitrogen ≤the upper limit of normal value
Liver function
ast and alt ≤1.5 times normal upper limit; total bilirubin ≤1.5 times the upper limit of normal value
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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