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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

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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