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

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	Not Applicable

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
• Actual Primary Completion Date: December 2017
• Estimated Study Completion Date: December 2020

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) [ 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. 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 ]

Eligibility Criteria

• Ages Eligible for Study: up to 65 Years (Child, Adult, Older 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

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
• Other Study ID Numbers: CSEM GOG-002; 2012-GYN/CC-01 ( Other Identifier: Tongji Hospital, HUST )
• First Posted: December 24, 2012
• Last Update Posted: April 21, 2020
• Last Verified: February 2020

Additional relevant MeSH terms:

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