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

• ClinicalTrials.gov Identifier: NCT01755897
• Recruitment Status: Active, not recruiting
• First Posted: December 24, 2012
• Last Update Posted: April 21, 2020
• Sponsor: Huazhong University of Science and Technology
• Collaborators: Zhejiang University; Shandong University
• Information provided by (Responsible Party): Ding Ma, Huazhong University of Science and Technology

Tracking Information

• First Submitted Date: December 19, 2012
• First Posted Date: December 24, 2012
• Last Update Posted Date: April 21, 2020
• Study Start Date: November 2012
• Actual Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 28, 2020)

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.

Original Primary Outcome Measures (submitted: December 21, 2012)

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.

Current Secondary Outcome Measures (submitted: February 28, 2020)

• 3-year overall survivals (OS) [ Time Frame: 3-year ]
• Quality of Life in two arms [ Time Frame: 3 years ]
• chemotherapy- and radiotherapy- related adverse effects respectively in two arms [ Time Frame: 3 years ]

Original Secondary Outcome Measures (submitted: December 21, 2012)

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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Multicenter, Prospective, Randomized Trial of Adjuvant Chemotherapy for Early-Stage Cervical Cancer Patients
• Official Title: A Multicenter, Prospective, Randomized Trial of Adjuvant Chemotherapy for Early-Stage Cervical Cancer Patients
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Uterine Cervical Neoplasms
• Cervical Cancer
• Uterine Cervical Cancer

Intervention

• 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
• Drug: Cisplatin
  35 mg/m(2) IV once a week
• Radiation: Pelvic RT
  IMRT

Study Arms

• 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.
  Interventions:

  • Procedure: radical hysterectomy + pelvic lymph node dissection
  • Drug: Paclitaxel
  • Drug: Cisplatin
• 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.
  Interventions:

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: December 21, 2012): 300
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2020
• Actual Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: up to 65 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT01755897
• Other Study ID Numbers: CSEM GOG-002; 2012-GYN/CC-01 ( Other Identifier: Tongji Hospital, HUST )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Ding Ma, Huazhong University of Science and Technology
• Study Sponsor: Huazhong University of Science and Technology

Collaborators

• Zhejiang University
• Shandong University

Investigators

• Study Chair: Ding Ma, MD, PhD; Huazhong University of Science and Technology

• PRS Account: Huazhong University of Science and Technology
• Verification Date: February 2020