NCT Number: NCT01755897
A Multicenter, Prospective, Randomized Trial of Adjuvant Chemotherapy for Early-Stage Cervical Cancer Patients
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.
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Conditions
Age range
Up to 65 year
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
paclitaxel
Drug135-175 mg/m(2) intravenously (IV) on day 1
Cisplatin
Drug75 mg/m(2) IV on day 2 and 3
Pelvic RT
RadiationIMRT
Primary outcomes
-
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 outcomes
-
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
Sponsors and collaborators
Lead sponsor
Huazhong University of Science and Technology
Other
Collaborators
- Shandong University
- Zhejiang University
Registry information
Acronym: CC-01
Important dates
- Study start
- 2012
- Primary completion
- 2017
- Study completion
- 2020
- First posted
- Dec 24, 2012
- Registry last updated
- May 9, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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