Neoadjuvant Chemotherapy + Surgery Versus Surgery in FIGO IB2 and IIA2 Cervical Cancer (SYSGO-003)

Sun Yat-sen University

Status and phase: Unknown; Phase 3

Conditions: PFS; Quality of Life; OS

Treatments: Procedure: radical surgery; Drug: NACT (Paclitaxel + Cisplatin or carboplatin)

Study type: Interventional

Funder types: Other

Identifiers

NCT02629718

2015-FXY-069

Details and patient eligibility

About

To clarify the potential benefits of NACT before radical surgery(RS), we perform a phase III, randomised controlled trial to compare NACT plus RS with RS alone in patients with stages IB2 and IIA2 cervical cancer.

Full description

Patients with International Federation of Gynecology and Obstetrics (FIGO) stage IB2 and IIA2 cervical cancer are eligible for our study. They will receive paclitaxel + cisplatin(TP)/carboplatin(TC) regimen neoadjuvant chemotherapy (NACT) 3 cycles followed by radical surgery (RS) (type III to V radical hysterectomy plus systematic pelvic lymphadenectomy) (arm A) or directly radical surgery (arm B). Postoperative pelvic radiotherapy will be started within 6 weeks after surgery if the patients have pelvic lymph node metastasis, parametrial involvement, deep stromal invasion or positive margin. Extended-field external beam therapy, delivering a dose of 4500cGy by a four-field technique, will be administered to patients with positive para-aortic nodes. High-dose rate brachytherapy will be delivered to the vaginal stump if patients have positive surgical margins. The primary end point is 2-years progression-free survival, The secondary end points is overall survival , rate of response to TP or TC regimen chemotherapy and the quality of life.

Enrollment: 700 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with newly histologically confirmed cervical carcinoma;
• Histopathology squamaous carcinoma, adenocarcinoma or adeno-squamous carcinoma;
• Original clinical stage must be IB2 or IIA2 （FIGO);
• Age between 18-65;
• Patients must give signed informed consent;
• P.S status: 0-1;
• Estimated survival time > 3 months;

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/mm;
• Accompany with other malignancy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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700 participants in 2 patient groups

A(NACT)

Experimental group

Description:

Neoadjuvant Chemotherapy followed by Radical Surgery

Treatment:

Drug: NACT (Paclitaxel + Cisplatin or carboplatin)

Procedure: radical surgery

B(RS)

Active Comparator group

Description:

Radical Surgery alone

Treatment:

Procedure: radical surgery