Randomized Prospective Clinical Study of Neoadjuvant Chemotherapy Versus Definite Concurrent Chemoradiotherapy for Locally Advanced Bulk Cervical Cancer

• Status: Recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chuangzhen Chen
• Treatments: Gemcitabine

Criteria

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.