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Study of Neoadjuvant Chemotherapy Versus Definite Concurrent Chemoradiotherapy for Locally Advanced Bulk Cervical Cancer
RECRUITINGPhase 3Sponsored by Chuangzhen Chen
Actively Recruiting
PhasePhase 3
SponsorChuangzhen Chen
Started2021-07-01
Est. completion2025-06
Eligibility
Age18 Years – 70 Years
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05189028
Summary
This phase III randomized prospective clinical study was conducted to compare the short-term and long-term outcomes of gemcitabine and cisplatin neoadjuvant chemotherapy versus definite cisplatin weekly concurrent chemoradiotherapy in patients with locally advanced bulk cervical cancer.
Eligibility
Age: 18 Years – 70 YearsSex: FEMALEHealthy volunteers accepted
Inclusion Criteria: * Histologic proof of primary cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma. * According to the 2018 International Federation of Cervical Cancer Obstetrics and Gynecology (FIGO) staging standard, the patient was diagnosed with local tumor ≥4cm in stage IB3, IIA2, IIB-IVA by at least one expert with associate high degree or above in the department of gynecology and gynecology. * Age≥18 \& ≤70. * ECOG score 0-2. * WBC ≥4.0×109/L, hemoglobin ≥60g/L, platelet ≥100.0×109/L; Serum bilirubin ≤ upper limit of normal, ALT, AST, ALP ≤ upper limit of normal ×2.5; Urea nitrogen (BUN) ≤ upper limit of normal ×1.5, creatinine (Cr)≤ upper limit of normal ×1.5. * Patients with prior malignancy are eligible if disease-free ≥ 5 years. * Signed study-specific informed consent form prior to study entry. Exclusion Criteria: * Line has anti-tumor treatment, including chemotherapy, radiotherapy, surgery). * Stage Ia1- IB2 and IVB cervical cancer. * Patients with uncontrolled serious medical or mental illnesses. * Women in pregnancy or lactation. * Psychological, family, social factors, such as lead to no informed consent. * Into the group of the first five years in addition to the cervical cancer merger other patients with a history of malignant tumor.
Conditions3
CancerCervical CancerNeoadjuvant Chemotherapy
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Actively Recruiting
PhasePhase 3
SponsorChuangzhen Chen
Started2021-07-01
Est. completion2025-06
Eligibility
Age18 Years – 70 Years
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05189028