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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
First received
Last updated
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
Health authority
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.

Study Design


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
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