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

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ClinicalTrials.gov Identifier: NCT01755897
Recruitment Status : Active, not recruiting
First Posted : December 24, 2012
Last Update Posted : October 10, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

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
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 Design

Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 2012
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer
U.S. FDA Resources

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) 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.


Secondary Outcome Measures :
  1. DFS of the adjuvant CCRT arm (arm B) [ Time Frame: 1-year DFS and 3-year DFS ]
  2. 3-year overall survivals (OS) of the arm A and the arm B [ Time Frame: 3-year ]
  3. Quality of Life in two arms [ Time Frame: 3 years ]
  4. chemotherapy- and radiotherapy- related adverse effects respectively in two arms [ Time Frame: 3 years ]

Eligibility Criteria

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Ages Eligible for Study:   up to 60 Years   (Child, Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01755897


Locations
China, Hubei
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
China, Shandong
Qilu Hospital, Shandong University
Jinan, Shandong, China, 250012
China, Zhejiang
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
More Information

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: CSEM GOG-002
2012-GYN/CC-01 ( Other Identifier: Tongji Hospital, HUST )
First Posted: December 24, 2012    Key Record Dates
Last Update Posted: October 10, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Paclitaxel
Cisplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action