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

Quality of Life Clinical Trial

— SYSGO-003  

Official title:

A Trial of Neoadjuvant Chemotherapy Followed by Surgery Versus Surgery in FIGO IB2 and IIA2 Cervical Cancer(CSEM005)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02629718
• Other study ID #: 2015-FXY-069
• Status: Recruiting
• Phase: Phase 3
• First received: December 10, 2015
• Last updated: March 14, 2018
• Start date: December 2015
• Est. completion date: December 2022

Study information

• Verified date: March 2018
• Source: Sun Yat-sen University
• Contact: Jihong Liu, Ph. D
• Phone: 86-20-87343102
• Email: Liujih[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• OS
• PFS
• Quality of Life
• Uterine Cervical Neoplasms

Intervention

Drug:
• NACT (Paclitaxel + Cisplatin or carboplatin)
Paclitaxel 150mg/m2 over 3 hours + Cisplatin 70mg/m2 or carboplatin AUC = 6, repeat per 21 days, 3 cycles.

Procedure:
• radical surgery
Radical hysterectomy (Piver Type III or Type IV hysterectomy) plus bilateral pelvic lymph node dissection and para-aortic lymph node dissection or sampling

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center, Department of Gynecologic Oncology	GuangZhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease free survival		2 years
Secondary	overall survival		5 years
Secondary	quality of life		3 years