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

Sponsor
Huazhong University of Science and Technology (Other)
Overall Status
Unknown status
CT.gov ID
NCT01755897
Collaborator
Zhejiang University (Other), Shandong University (Other)
300
Enrollment
3
Locations
2
Arms
97
Duration (Months)
100
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Prospective, Randomized Trial of Adjuvant Chemotherapy for Early-Stage Cervical Cancer Patients
Study Start Date :
Nov 1, 2012
Actual Primary Completion Date :
Dec 1, 2017
Anticipated Study Completion Date :
Dec 1, 2020

Arms and Interventions

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
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

Outcome Measures

Primary Outcome Measures

  1. disease-free survival (DFS) [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.

Secondary Outcome Measures

  1. 3-year overall survivals (OS) [3-year]

  2. Quality of Life in two arms [3 years]

  3. chemotherapy- and radiotherapy- related adverse effects respectively in two arms [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei China 430030
2 Qilu Hospital, Shandong University Jinan Shandong China 250012
3 Women's Hospital, School of Medicine, Zhejiang University Hangzhou Zhejiang China 310006

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ding Ma, Director of Department of Gynecology and Obstetrics, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01755897
Other Study ID Numbers:
  • CSEM GOG-002
  • 2012-GYN/CC-01
First Posted:
Dec 24, 2012
Last Update Posted:
Apr 21, 2020
Last Verified:
Feb 1, 2020
Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Paclitaxel
Cisplatin

Study Results

No Results Posted as of Apr 21, 2020