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

Cervical Cancer Clinical Trial

— CC-01  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01755897
• Other study ID #: CSEM GOG-002
• Secondary ID: 2012-GYN/CC-01
• Status: Completed
• Phase: N/A
• Start date: November 2012
• Est. completion date: December 2020

Study information

• Verified date: May 2023
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 337
• Est. completion date: December 2020
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 65 Years

Eligibility

Inclusion Criteria:

• FIGO stage: ?B~?A, 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: ? lymph node metastasis, ? parametrial invasion, ? = 2/3 deep stromal invasion, ? histopathological grading in poorly differentiated (G2 to G3), ? lymphatic vascular space involvement, ? 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.

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Procedure:
• radical hysterectomy + pelvic lymph node dissection

Drug:
• Paclitaxel
135-175 mg/m(2) intravenously (IV) on day 1
• Cisplatin
75 mg/m(2) IV on day 2 and 3
• Cisplatin
35 mg/m(2) IV once a week

Radiation:
• Pelvic RT
IMRT

Locations

Country	Name	City	State
China	Women's Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang
China	Qilu Hospital, Shandong University	Jinan	Shandong
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (3)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology	Shandong University, Zhejiang University

Country where clinical trial is conducted

China, 

References & Publications (1)

Weng D, Xiong H, Zhu C, Wan X, Chen Y, Wang X, Zhang Y, Jiang J, Zhang X, Gao Q, Chen G, Xing H, Wang C, Li K, Chen Y, Mao Y, Hu D, Pan Z, Chen Q, Cui B, Song K, Yi C, Peng G, Han X, An R, Fan L, Wang W, Xiong T, Chen Y, Tang Z, Li L, Yang X, Cheng X, Lu W, Wang H, Kong B, Xie X, Ma D. Adjuvant chemotherapy versus adjuvant concurrent chemoradiotherapy after radical surgery for early-stage cervical cancer: a randomized, non-inferiority, multicenter trial. Front Med. 2023 Feb;17(1):93-104. doi: 10.1007/s11684-021-0892-z. Epub 2022 Nov 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease-free survival (DFS)	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.	up to 3-year
Secondary	3-year overall survivals (OS)		3-year
Secondary	Quality of Life in two arms		3 years
Secondary	chemotherapy- and radiotherapy- related adverse effects respectively in two arms		3 years