Neoadjuvant Chemotherapy and Radical Surgery Versus Concurrent Chemoirradiation in FIGO Stage IIB Cervical Cancer
Overview
- Phase
- Phase 3
- Intervention
- Concurrent chemoirradiation
- Conditions
- Cervical Carcinoma Stage IIB
- Sponsor
- Sun Yat-sen University
- Enrollment
- 220
- Locations
- 1
- Primary Endpoint
- Disease free survival
- Last Updated
- 9 years ago
Overview
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).
Investigators
Jihong Liu
Sun Yat-sen University Cancer Center
Sun Yat-sen University
Eligibility Criteria
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
Arms & Interventions
Concurrent chemoirradiation (CCRT)
Concurrent chemoirradiation
Intervention: Concurrent chemoirradiation
NACT+Surgery
Neoadjuvant chemotherapy with Paclitaxel and Cisplatin (3 cycles), followed by radical surgery
Intervention: Paclitaxel
NACT+Surgery
Neoadjuvant chemotherapy with Paclitaxel and Cisplatin (3 cycles), followed by radical surgery
Intervention: Radical Surgery
NACT+Surgery
Neoadjuvant chemotherapy with Paclitaxel and Cisplatin (3 cycles), followed by radical surgery
Intervention: Cisplatin
Outcomes
Primary Outcomes
Disease free survival
Time Frame: 5 years
Secondary Outcomes
- Overall survival(5 years)