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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Huazhong University of Science and Technology
Sponsor:
Collaborators:
Zhejiang University
Shandong University
Information provided by (Responsible Party):
Ding Ma, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01755897
First received: December 19, 2012
Last updated: March 21, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Uterine Cervical Neoplasms
Cervical Cancer
Uterine Cervical Cancer
Procedure: radical hysterectomy + pelvic lymph node dissection
Drug: Paclitaxel
Drug: Cisplatin
Radiation: Pelvic RT
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Prospective, Randomized Trial of Adjuvant Chemotherapy for Early-Stage Cervical Cancer Patients

Resource links provided by NLM:


Further study details as provided by Huazhong University of Science and Technology:

Primary Outcome Measures:
  • disease-free survival (DFS) of the adjuvant chemotherapy arm (arm A) [ Time Frame: up to 3-year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • DFS of the adjuvant CCRT arm (arm B) [ Time Frame: 1-year DFS and 3-year DFS ] [ Designated as safety issue: No ]
  • 3-year overall survivals (OS) of the arm A and the arm B [ Time Frame: 3-year ] [ Designated as safety issue: No ]
  • Quality of Life in two arms [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • chemotherapy- and radiotherapy- related adverse effects respectively in two arms [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: November 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
35 mg/m(2) IV once a week
Radiation: Pelvic RT
IMRT

  Eligibility

Ages Eligible for Study:   up to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01755897

Contacts
Contact: Danhui Weng, MD +862783662681 weng.dh@gmail.com

Locations
China, Hubei
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China, 430030
Contact: Danhui Weng, MD    +862783662681    weng.dh@gmail.com   
Principal Investigator: Hui Wang, MD         
China, Shandong
Qilu Hospital, Shandong University Recruiting
Jinan, Shandong, China, 250012
Contact: Baoxia Cui, MD       baoxiacui@hotmail.com   
Principal Investigator: Baoxia Cui, MD         
China, Zhejiang
Women's Hospital, School of Medicine, Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310006
Contact: Changkun Zhu, MD       zhuchangkun@zju.edu.cn   
Principal Investigator: Changkun Zhu, MD         
Sponsors and Collaborators
Huazhong University of Science and Technology
Zhejiang University
Shandong University
Investigators
Study Chair: Ding Ma, MD, PhD Huazhong University of Science and Technology
  More Information

No publications provided

Responsible Party: Ding Ma, Director of Department of Gynecology and Obstetrics, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT01755897     History of Changes
Other Study ID Numbers: 2012-GYN/CC-01
Study First Received: December 19, 2012
Last Updated: March 21, 2013
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Cisplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 24, 2014