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

Launched by CHUANGZHEN CHEN · Dec 27, 2021

Keywords

ClinConnect Summary

This clinical trial is studying two different treatment approaches for women with locally advanced cervical cancer, which is a type of cancer that starts in the cervix and has grown larger than 4 centimeters. The researchers want to find out whether a combination of chemotherapy drugs (gemcitabine and cisplatin) given before surgery is more effective than giving chemotherapy along with radiation therapy at the same time. This study is currently looking for participants, specifically women aged 18 to 70 who have been diagnosed with certain types of cervical cancer and meet specific health criteria.

To be eligible for the trial, participants need to have a confirmed diagnosis of cervical cancer that meets certain size and stage requirements. They should also be in relatively good health, with specific blood test results showing they can handle treatment. Throughout the trial, participants will receive either the neoadjuvant chemotherapy or concurrent chemoradiotherapy and will be monitored for both short-term and long-term effects of these treatments. It's important to note that women who are pregnant, breastfeeding, or have serious uncontrolled health issues cannot participate. This study is a crucial step in understanding how to treat cervical cancer more effectively and may help improve outcomes for future patients.

Gender

FEMALE

Eligibility 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.