Neoadjuvant Chemotherapy and Radical Surgery in Stage IIB Cervical Cancer (SYSGO002)

Sun Yat-sen University

Status and phase: Unknown; Phase 3

Conditions: Cervical Carcinoma Stage IIB

Treatments: Radiation: Concurrent chemoirradiation; Drug: Paclitaxel; Drug: Cisplatin; Procedure: Radical Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT02595554

CSEM007

Details and patient eligibility

About

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.

Full 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).

Enrollment: 220 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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220 participants in 2 patient groups

Concurrent chemoirradiation (CCRT)

Active Comparator group

Description:

Concurrent chemoirradiation

Treatment:

Radiation: Concurrent chemoirradiation

NACT+Surgery

Experimental group

Description:

Neoadjuvant chemotherapy with Paclitaxel and Cisplatin (3 cycles), followed by radical surgery

Treatment:

Procedure: Radical Surgery

Drug: Cisplatin

Drug: Paclitaxel