Neoadjuvant Chemotherapy and Radical Surgery in Stage IIB Cervical Cancer

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02595554

Acronym

SYSGO002

Enrollment

220

Registered

2015-11-03

Start date

2015-11-30

Completion date

2020-12-31

Last updated

2017-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Carcinoma Stage IIB

Keywords

Cervical cancer, Stage IIB, Neoadjuvant chemotherapy

Brief 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.

Detailed 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).

Interventions

RADIATIONConcurrent chemoirradiation

External beam radiation therapy (EBRT) with concurrent weekly platinum chemotherapy followed by brachytherapy

DRUGPaclitaxel

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

PROCEDURERadical Surgery

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

DRUGCisplatin

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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Disease free survival	5 years

Secondary

Measure	Time frame
Overall survival	5 years

Countries

China

Contacts

Primary ContactJihong Liu, Ph. D

Liujih@mail.sysu.edu.cn86-20-87343102

Backup ContactHe Huang, Ph. D

Huangh@sysucc.org.cn86-20-87343014

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026