Neoadjuvant Chemotherapy and Radical Surgery in Stage IIB Cervical Cancer

Phase 3

• Conditions: Cervical Carcinoma Stage IIB
• Interventions: Radiation: Concurrent chemoirradiation; Drug: Paclitaxel; Procedure: Radical Surgery; Drug: Cisplatin

• Registration Number: NCT02595554
• Lead Sponsor: Sun Yat-sen University

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).

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-02
• Study First Submitted QC: 2015-11-02
• Study First Posted: 2015-11-03
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-02
• Last Update Posted: 2017-02-03
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 220

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Concurrent chemoirradiation (CCRT)	Concurrent chemoirradiation	Concurrent chemoirradiation
NACT+Surgery	Radical Surgery	Neoadjuvant chemotherapy with Paclitaxel and Cisplatin (3 cycles), followed by radical surgery
NACT+Surgery	Paclitaxel	Neoadjuvant chemotherapy with Paclitaxel and Cisplatin (3 cycles), followed by radical surgery
NACT+Surgery	Cisplatin	Neoadjuvant chemotherapy with Paclitaxel and Cisplatin (3 cycles), followed by radical surgery

Primary Outcome Measures

Name	Time	Method
Disease free survival	5 years

Secondary Outcome Measures

Name	Time	Method
Overall survival	5 years

Trial Locations

Locations (1)

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