Status:
RECRUITING
Study of Neoadjuvant Chemotherapy Versus Definite Concurrent Chemoradiotherapy for Locally Advanced Bulk Cervical Cancer
Lead Sponsor:
Chuangzhen Chen
Conditions:
Cervical Cancer
Neoadjuvant Chemotherapy
Eligibility:
FEMALE
18-70 years
Phase:
PHASE3
Brief 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 week...
Detailed Description
Platinum-based concurrent chemoradiotherapy is the standard of care recommended by the NCCN for locally advanced cervical cancer of stage IB3, IIA2 and IIB-IVA (2018 FIGO stage) (cervical tumor ≥4cm)....
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
290 Patients enrolled
Trial Details
Trial ID
NCT05189028
Start Date
July 1 2021
End Date
June 1 2025
Last Update
February 6 2024
Active Locations (1)
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1
Cancer Hospital, Shantou University Medical College
Shantou, Guangdong, China, 515031