Neoadjuvant Chemotherapy + Surgery Versus Surgery in FIGO IB2 and IIA2 Cervical Cancer

Last updated: March 14, 2018
Sponsor: Sun Yat-sen University
Overall Status: Active - Recruiting

Phase

3

Condition

Cervical Cancer

Uterine Disorders

Treatment

N/A

Clinical Study ID

NCT02629718
2015-FXY-069
  • Ages 18-65
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

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

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.

Study Design

Total Participants: 700
Study Start date:
December 01, 2015
Estimated Completion Date:
December 31, 2022

Study 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.

Connect with a study center

  • Sun Yat-sen University Cancer Center, Department of Gynecologic Oncology

    GuangZhou, Guangdong 510060
    China

    Active - Recruiting

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