A Multicenter, Prospective, Randomized Trial of Adjuvant Chemotherapy for Early-Stage Cervical Cancer Patients
CC-01
2 other identifiers
interventional
337
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2012
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 19, 2012
CompletedFirst Posted
Study publicly available on registry
December 24, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedMay 9, 2023
May 1, 2023
5.1 years
December 19, 2012
May 7, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
3-year overall survivals (OS)
3-year
Quality of Life in two arms
3 years
chemotherapy- and radiotherapy- related adverse effects respectively in two arms
3 years
Study Arms (2)
Adjuvant Chemotherapy (Arm A)
EXPERIMENTALPaclitaxel (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.
Concurrent radiochemotherapy, CCRT (Arm B)
ACTIVE COMPARATORPelvic 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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Huazhong University of Science and Technologylead
- Zhejiang Universitycollaborator
- Shandong Universitycollaborator
Study Sites (3)
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
Qilu Hospital, Shandong University
Jinan, Shandong, 250012, China
Women's Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310006, China
Related 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.
PMID: 36422763BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ding Ma, MD, PhD
Huazhong University of Science and Technology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Department of Gynecology and Obstetrics
Study Record Dates
First Submitted
December 19, 2012
First Posted
December 24, 2012
Study Start
November 1, 2012
Primary Completion
December 1, 2017
Study Completion
December 1, 2020
Last Updated
May 9, 2023
Record last verified: 2023-05