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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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PFS OS Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A(NACT)

Neoadjuvant Chemotherapy followed by Radical Surgery

Group Type EXPERIMENTAL

NACT (Paclitaxel + Cisplatin or carboplatin)

Intervention Type DRUG

Paclitaxel 150mg/m2 over 3 hours + Cisplatin 70mg/m2 or carboplatin AUC = 6, repeat per 21 days, 3 cycles.

radical surgery

Intervention Type PROCEDURE

Radical hysterectomy (Piver Type III or Type IV hysterectomy) plus bilateral pelvic lymph node dissection and para-aortic lymph node dissection or sampling

B(RS)

Radical Surgery alone

Group Type ACTIVE_COMPARATOR

radical surgery

Intervention Type PROCEDURE

Radical hysterectomy (Piver Type III or Type IV hysterectomy) plus bilateral pelvic lymph node dissection and para-aortic lymph node dissection or sampling

Interventions

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NACT (Paclitaxel + Cisplatin or carboplatin)

Paclitaxel 150mg/m2 over 3 hours + Cisplatin 70mg/m2 or carboplatin AUC = 6, repeat per 21 days, 3 cycles.

Intervention Type DRUG

radical surgery

Radical hysterectomy (Piver Type III or Type IV hysterectomy) plus bilateral pelvic lymph node dissection and para-aortic lymph node dissection or sampling

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No