Clinical trial NCT02629718: Neoadjuvant Chemotherapy + Surgery Versus Surgery in FIGO IB2 and IIA2 Cervical Cancer
Official title: A Trial of Neoadjuvant Chemotherapy Followed by Surgery Versus Surgery in FIGO IB2 and IIA2 Cervical Cancer(CSEM005)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: PFS
OS
Quality of Life
Keywords: neoadjuvant chemotherapy
radical surgery
cervical carcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2015-12-14
Enrollment: 700
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To clarify the potential benefits of NACT before radical surgery(RS), we perform a phase III, randomised controlled trial to compare NACT plus RS with RS alone in patients with stages IB2 and IIA2 cervical cancer.

Detailed description: Patients with International Federation of Gynecology and Obstetrics (FIGO) stage IB2 and IIA2 cervical cancer are eligible for our study. They will receive paclitaxel + cisplatin(TP)/carboplatin(TC) regimen neoadjuvant chemotherapy (NACT) 3 cycles followed by radical surgery (RS) (type III to V radical hysterectomy plus systematic pelvic lymphadenectomy) (arm A) or directly radical surgery (arm B). Postoperative pelvic radiotherapy will be started within 6 weeks after surgery if the patients have pelvic lymph node metastasis, parametrial involvement, deep stromal invasion or positive margin. Extended-field external beam therapy, delivering a dose of 4500cGy by a four-field technique, will be administered to patients with positive para-aortic nodes. High-dose rate brachytherapy will be delivered to the vaginal stump if patients have positive surgical margins. The primary end point is 2-years progression-free survival, The secondary end points is overall survival , rate of response to TP or TC regimen chemotherapy and the quality of life.

Eligibility criteria: Inclusion Criteria:

* Patients with newly histologically confirmed cervical carcinoma;
* Histopathology squamaous carcinoma, adenocarcinoma or adeno-squamous carcinoma;
* Original clinical stage must be IB2 or IIA2 （FIGO);
* Age between 18-65;
* Patients must give signed informed consent;
* P.S status: 0-1;
* Estimated survival time \> 3 months;

Exclusion Criteria:

* The presence of uncontrolled life-threatening illness;
* Receiving other ways of anti-cancer therapy;
* Investigator consider the patients can't finish the whole study;
* With normal liver function test (ALT、AST\>2.5×ULN);
* With normal renal function test (Creatinine\>1.5×ULN);
* WBC\<4,000/mm3 or PLT\<100,000/mm;
* Accompany with other malignancy.

Primary outcomes:
measure: Disease free survival
timeFrame: 2 years
Secondary outcomes:
measure: overall survival
timeFrame: 5 years
measure: quality of life
timeFrame: 3 years
Other outcomes:
Locations:
city: GuangZhou
country: China
facility: Sun Yat-sen University Cancer Center, Department of Gynecologic Oncology
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Jihong Liu, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: