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Completed

NCT Number: NCT01755897

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

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.

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Key information

Age range

Up to 65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Radical Hysterectomy + pelvic lymph node dissection

Procedure

paclitaxel

Drug

135-175 mg/m(2) intravenously (IV) on day 1

Cisplatin

Drug

75 mg/m(2) IV on day 2 and 3

Pelvic RT

Radiation

IMRT

Primary outcomes

  1. 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.

Secondary outcomes

  1. 3-year overall survivals (OS)

    Time frame: 3-year

  2. Quality of Life in two arms

    Time frame: 3 years

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

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Huazhong University of Science and Technology

Other

Collaborators

  • Shandong University
  • Zhejiang University

Registry information

Acronym: CC-01

Important dates

Study start
2012
Primary completion
2017
Study completion
2020
First posted
Dec 24, 2012
Registry last updated
May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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