Neoadjuvant Chemotherapy and Radical Surgery in Stage IIB Cervical Cancer

Cervical Carcinoma Stage IIB Clinical Trial

— SYSGO002  

Official title:

Neoadjuvant Chemotherapy and Radical Surgery Versus Concurrent Chemoirradiation in FIGO Stage IIB Cervical Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02595554
• Other study ID #: CSEM007
• Status: Recruiting
• Phase: Phase 3
• First received: November 2, 2015
• Last updated: February 2, 2017
• Start date: November 2015
• Est. completion date: December 2020

Study information

• Verified date: February 2017
• 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

Neoadjuvant chemotherapy (NACT) and radical surgery (RS) may have a possible better outcome to concurrent chemoirradiation (CCRT) in stage IIB cervical cancer. We try to verify such a hypothesis in terms of survival and treatment related morbidity.

Description:

Patients with International Federation of Gynecology and Obstetrics (FIGO) stage IIB cervical cancer are eligible for our study. They will receive cisplatin based neoadjuvant chemotherapy (NACT) 3 cycles followed by radical surgery (RS) (type III to V radical hysterectomy plus systematic pelvic lymphadenectomy) (arm A) or external beam radiation (EBRT) with concurrent weekly platinum 40mg/m2 followed by brachyradiotherapy (arm B).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients with newly histologically confirmed cervical carcinoma

• Original clinical stage must be IIB (FIGO 2009)

• Histopathology squamous carcinoma, adenocarcinoma or adeno-squamous carcinoma

• Age between 18-65

• Patients must give signed informed consent

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/mm3

Related Conditions & MeSH terms

• Cervical Carcinoma Stage IIB
• Uterine Cervical Neoplasms

Intervention

Radiation:
• Concurrent chemoirradiation
External beam radiation therapy (EBRT) with concurrent weekly platinum chemotherapy followed by brachytherapy

Drug:
• Paclitaxel
New adjuvant chemotherapy 3 cycles with Paclitaxel 150mg/m2 over 3 hours and Cisplatin

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

Drug:
• Cisplatin
New adjuvant chemotherapy 3 cycles with Paclitaxel and Cisplatin 70mg/m2

Locations

Country	Name	City	State
China	Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center	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		5 years
Secondary	Overall survival		5 years