Neoadjuvant Chemotherapy + Surgery Versus Surgery in FIGO IB2 and IIA2 Cervical Cancer (SYSGO-003)

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

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.

Study Overview

• Status: Unknown
• Conditions: Quality of Life; PFS; OS
• Intervention / Treatment: Drug: NACT (Paclitaxel + Cisplatin or carboplatin); Procedure: radical surgery

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 Type: Interventional
• Enrollment (Anticipated): 700
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jihong Liu, Ph. D; Phone Number: 86-20-87343102; Email: Liujih@mail.sysu.edu.cn
• Study Contact Backup: Name: Ting Wan, Ph. D; Phone Number: 86-20-87343014; Email: wanting@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • GuangZhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat-sen University Cancer Center, Department of Gynecologic Oncology
      • Contact: Ting Wan, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A(NACT); Neoadjuvant Chemotherapy followed by Radical Surgery	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
Active Comparator: B(RS); Radical Surgery alone	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Disease free survival	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
overall survival	5 years
quality of life	3 years

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: December 10, 2015
• First Submitted That Met QC Criteria: December 11, 2015
• First Posted (Estimate): December 14, 2015

Study Record Updates

• Last Update Posted (Actual): March 16, 2018
• Last Update Submitted That Met QC Criteria: March 14, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: cervical carcinoma; neoadjuvant chemotherapy; radical surgery
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Carboplatin; Paclitaxel
• Other Study ID Numbers: 2015-FXY-069

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No