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

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.

Study Overview

• Status: Completed
• Conditions: Cervical Cancer; Uterine Cervical Neoplasms; Uterine Cervical Cancer
• Intervention / Treatment: Procedure: radical hysterectomy + pelvic lymph node dissection; Drug: Paclitaxel; Drug: Cisplatin; Drug: Cisplatin; Radiation: Pelvic RT

• Study Type: Interventional
• Enrollment (Actual): 337
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Shandong
    • Jinan, Shandong, China, 250012
      • Qilu Hospital, Shandong University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • Women's Hospital, School of Medicine, Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adjuvant Chemotherapy (Arm A); 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.	Procedure: radical hysterectomy + pelvic lymph node dissection; Drug: Paclitaxel; 135-175 mg/m(2) intravenously (IV) on day 1; Drug: Cisplatin; 75 mg/m(2) IV on day 2 and 3; Drug: Cisplatin; 35 mg/m(2) IV once a week
Active Comparator: Concurrent radiochemotherapy, CCRT (Arm B); 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.	Procedure: radical hysterectomy + pelvic lymph node dissection; Drug: Cisplatin; 75 mg/m(2) IV on day 2 and 3; Drug: Cisplatin; 35 mg/m(2) IV once a week; Radiation: Pelvic RT; IMRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
disease-free survival (DFS)	DFS was definite as the time from randomization to disease recurrence (including death from recurrence if it was the first manifestation of recurrence), death without recurrence.	up to 3-year

Secondary Outcome Measures

Outcome Measure	Time Frame
3-year overall survivals (OS)	3-year
Quality of Life in two arms	3 years
chemotherapy- and radiotherapy- related adverse effects respectively in two arms	3 years

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology
• Collaborators: Shandong University; Zhejiang University
• Investigators: Study Chair: Ding Ma, MD, PhD, Huazhong University of Science and Technology

Publications and helpful links

General Publications

• Weng D, Xiong H, Zhu C, Wan X, Chen Y, Wang X, Zhang Y, Jiang J, Zhang X, Gao Q, Chen G, Xing H, Wang C, Li K, Chen Y, Mao Y, Hu D, Pan Z, Chen Q, Cui B, Song K, Yi C, Peng G, Han X, An R, Fan L, Wang W, Xiong T, Chen Y, Tang Z, Li L, Yang X, Cheng X, Lu W, Wang H, Kong B, Xie X, Ma D. Adjuvant chemotherapy versus adjuvant concurrent chemoradiotherapy after radical surgery for early-stage cervical cancer: a randomized, non-inferiority, multicenter trial. Front Med. 2023 Feb;17(1):93-104. doi: 10.1007/s11684-021-0892-z. Epub 2022 Nov 23.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: December 19, 2012
• First Submitted That Met QC Criteria: December 21, 2012
• First Posted (Estimate): December 24, 2012

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 7, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel; Cisplatin
• Other Study ID Numbers: CSEM GOG-002; 2012-GYN/CC-01 (Other Identifier: Tongji Hospital, HUST)