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

H

Huazhong University of Science and Technology

Status

Completed

Conditions

Uterine Cervical Neoplasms
Uterine Cervical Cancer
Cervical Cancer

Treatments

Procedure: radical hysterectomy + pelvic lymph node dissection
Drug: Paclitaxel
Drug: Cisplatin
Radiation: Pelvic RT

Study type

Interventional

Funder types

Other

Identifiers

NCT01755897
2012-GYN/CC-01 (Other Identifier)
CSEM GOG-002

Details and patient eligibility

About

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.

Enrollment

337 patients

Sex

Female

Ages

Under 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

337 participants in 2 patient groups

Adjuvant Chemotherapy (Arm A)
Experimental group
Description:
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.
Treatment:
Drug: Cisplatin
Drug: Paclitaxel
Procedure: radical hysterectomy + pelvic lymph node dissection
Drug: Cisplatin
Concurrent radiochemotherapy, CCRT (Arm B)
Active Comparator group
Description:
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.
Treatment:
Drug: Cisplatin
Procedure: radical hysterectomy + pelvic lymph node dissection
Drug: Cisplatin
Radiation: Pelvic RT

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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