Neoadjuvant Chemotherapy + Surgery Versus Surgery in FIGO IB2 and IIA2 Cervical Cancer

Phase 3

• Conditions: OS; Quality of Life; PFS
• Interventions: Procedure: radical surgery; Drug: NACT (Paclitaxel + Cisplatin or carboplatin)

• Registration Number: NCT02629718
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-10
• Study First Submitted QC: 2015-12-11
• Study First Posted: 2015-12-14
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-14
• Last Update Posted: 2018-03-16
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 700

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B(RS)	radical surgery	Radical Surgery alone
A(NACT)	radical surgery	Neoadjuvant Chemotherapy followed by Radical Surgery
A(NACT)	NACT (Paclitaxel + Cisplatin or carboplatin)	Neoadjuvant Chemotherapy followed by Radical Surgery

Primary Outcome Measures

Name	Time	Method
Disease free survival	2 years

Secondary Outcome Measures

Name	Time	Method
quality of life	3 years
overall survival	5 years

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center, Department of Gynecologic Oncology; 🇨🇳 GuangZhou, Guangdong, China