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

Phase 3
60 Years
Open (Enrolling)
Uterine Cervical Neoplasms, Cervical Cancer, Uterine Cervical Cancer

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Trial Information

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

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

disease-free survival (DFS) of the adjuvant chemotherapy arm (arm A)

Outcome Description:

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.

Outcome Time Frame:

up to 3-year

Safety Issue:


Principal Investigator

Ding Ma, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Huazhong University of Science and Technology


China: Ministry of Health

Study ID:




Start Date:

November 2012

Completion Date:

December 2015

Related Keywords:

  • Uterine Cervical Neoplasms
  • Cervical Cancer
  • Uterine Cervical Cancer
  • Neoplasms
  • Uterine Cervical Neoplasms