A Multicenter, Prospective, Randomized Trial of Adjuvant Chemotherapy for Early-Stage Cervical Cancer Patients (CC-01)

Huazhong University of Science and Technology

Status: Completed

Conditions: Uterine Cervical Neoplasms; Uterine Cervical Cancer; Cervical Cancer

Treatments: Procedure: radical hysterectomy + pelvic lymph node dissection; Drug: Paclitaxel; Drug: Cisplatin; Radiation: Pelvic RT

Study type: Interventional

Funder types: Other

Identifiers

NCT01755897

2012-GYN/CC-01 (Other Identifier)

CSEM GOG-002

Details and patient eligibility

About

We will conduct a trial to determine whether paclitaxel/cisplatin (TP) as an adjuvant chemotherapy after radical surgery improve disease-free survival (DFS) and overall survival (OS), as well as the quality of life (QoL) among early-stage (FIGO stage IB-IIA) cervical cancer patients with risk factors.

Enrollment: 337 patients

Sex: Female

Ages: Under 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• FIGO stage: ⅠB～ⅡA, cervical cancer;
• Age≤60 years; female, Chinese women;
• Initial treatment is radical hysterectomy + pelvic lymph node dissection;
• Pathological diagnosis: cervical squamous cell invasive carcinoma;
• Pathologic examination and meet the following one of the indications of adjuvant therapy: ① lymph node metastasis, ② parametrial invasion, ③ ≥ 2/3 deep stromal invasion, ④ histopathological grading in poorly differentiated (G2 to G3), ⑤ lymphatic vascular space involvement, ⑥ tumor diameter> 4cm;
• Laboratory tests: WBC≥4×10(9)/L, NEU≥2×10(9)/L, PLT≥80×10(9)/L, serum bilirubin≤ 1.5 times the upper limit of normal, transaminase≤ 1.5 times the upper limit of normal, BUN, Cr≤ normal
• Performance status: Karnofsky score≥60;
• No prior treatment;
• Receiving extensive resection of uterus (type III) plus pelvic lymph nodes wide resection; pathologically diagnosed with cervical squamous cell carcinoma;
• Provide written informed consent.

Exclusion criteria

• With severe or uncontrolled internal disease, unable to receive surgery and/or unsuitable for radiotherapy or chemotherapy
• History of organ transplantation, immune diseases;
• History of serious mental illness, a history of brain dysfunction;
• Drug abuse or a history of drug abuse;
• Suffering from other malignancies;
• Concurrently participating in other clinical trials
• Unable or unwilling to sign informed consents;
• Unable or unwilling to abide by protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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337 participants in 2 patient groups

Adjuvant Chemotherapy (Arm A)

Experimental group

Description:

Paclitaxel (T): 135-175 mg/m(2) intravenously (IV) on day 1, administrated intravenously over 3 hours; followed by cisplatin 75-85 mg/m(2) IV on day 2 and 3. Patients received at least 3 cycles at 4-week intervals beginning 2-3 weeks after surgery. 3-6 cycles as necessary.

Treatment:

Drug: Cisplatin

Drug: Paclitaxel

Procedure: radical hysterectomy + pelvic lymph node dissection

Drug: Cisplatin

Concurrent radiochemotherapy, CCRT (Arm B)

Active Comparator group

Description:

Pelvic RT is delivered using IMRT technique, 45～50.4 Gy/4～7 weeks, brachytherapy will been given as necessary. Cisplatin 35 mg/m(2) IV once a week. Total treatment time is 6-7 weeks.

Treatment:

Drug: Cisplatin

Procedure: radical hysterectomy + pelvic lymph node dissection

Drug: Cisplatin

Radiation: Pelvic RT