Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01755897
Recruitment Status : Active, not recruiting
First Posted : December 24, 2012
Last Update Posted : April 21, 2020
Sponsor:
Collaborators:
Zhejiang University
Shandong University
Information provided by (Responsible Party):
Ding Ma, Huazhong University of Science and Technology

Tracking Information
First Submitted Date  ICMJE December 19, 2012
First Posted Date  ICMJE December 24, 2012
Last Update Posted Date April 21, 2020
Study Start Date  ICMJE November 2012
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2020)
disease-free survival (DFS) [ Time Frame: up to 3-year ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 21, 2012)
disease-free survival (DFS) of the adjuvant chemotherapy arm (arm A) [ Time Frame: up to 3-year ]
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2020)
  • 3-year overall survivals (OS) [ Time Frame: 3-year ]
  • Quality of Life in two arms [ Time Frame: 3 years ]
  • chemotherapy- and radiotherapy- related adverse effects respectively in two arms [ Time Frame: 3 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2012)
  • DFS of the adjuvant CCRT arm (arm B) [ Time Frame: 1-year DFS and 3-year DFS ]
  • 3-year overall survivals (OS) of the arm A and the arm B [ Time Frame: 3-year ]
  • Quality of Life in two arms [ Time Frame: 3 years ]
  • chemotherapy- and radiotherapy- related adverse effects respectively in two arms [ Time Frame: 3 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Multicenter, Prospective, Randomized Trial of Adjuvant Chemotherapy for Early-Stage Cervical Cancer Patients
Official Title  ICMJE A Multicenter, Prospective, Randomized Trial of Adjuvant Chemotherapy for Early-Stage Cervical Cancer Patients
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Uterine Cervical Neoplasms
  • Cervical Cancer
  • Uterine Cervical Cancer
Intervention  ICMJE
  • 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
  • Radiation: Pelvic RT
    IMRT
Study Arms  ICMJE
  • 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.
    Interventions:
    • Procedure: radical hysterectomy + pelvic lymph node dissection
    • Drug: Paclitaxel
    • Drug: Cisplatin
  • 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.
    Interventions:
    • Procedure: radical hysterectomy + pelvic lymph node dissection
    • Drug: Cisplatin
    • Radiation: Pelvic RT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: December 21, 2012)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE up to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01755897
Other Study ID Numbers  ICMJE CSEM GOG-002
2012-GYN/CC-01 ( Other Identifier: Tongji Hospital, HUST )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ding Ma, Huazhong University of Science and Technology
Study Sponsor  ICMJE Huazhong University of Science and Technology
Collaborators  ICMJE
  • Zhejiang University
  • Shandong University
Investigators  ICMJE
Study Chair: Ding Ma, MD, PhD Huazhong University of Science and Technology
PRS Account Huazhong University of Science and Technology
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP