Comparing chemotherapy and chemoradiotherapy for advanced cervical cancer

Phase III Randomized Prospective Clinical Study of Neoadjuvant Chemotherapy With Gemcitabine and Cisplatin(GP) Versus Definite Cisplatin Combined Weekly Chemoradiotherapy for Locally Advanced Bulk Cervical Cancer

This study is testing whether a new chemotherapy treatment or a combination of chemotherapy and radiation works better for people with advanced cervical cancer.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 290 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Shantou University Medical College (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Shantou, Guangdong)
• Trial ID: NCT05189028 on ClinicalTrials.gov

What this trial studies

This phase III clinical study aims to compare the effectiveness of neoadjuvant chemotherapy using gemcitabine and cisplatin against concurrent chemoradiotherapy with cisplatin in patients with locally advanced bulk cervical cancer. The study focuses on patients diagnosed with cervical cancer stages IB3, IIA2, and IIB-IVA, specifically those with tumors measuring 4 cm or larger. Participants will be monitored for both short-term and long-term outcomes to determine which treatment approach yields better survival rates and fewer side effects.

Who should consider this trial

Good fit: Ideal candidates for this study are women aged 18 to 70 with histologically confirmed locally advanced cervical cancer measuring 4 cm or larger.

Not a fit: Patients with early-stage cervical cancer (stage Ia1-IB2) or advanced stage (IVB) are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients with locally advanced cervical cancer, potentially improving survival rates.

How similar studies have performed: Other studies have shown promising results with neoadjuvant chemotherapy in cervical cancer, but this specific comparison of treatment approaches is relatively novel.

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.

Where this trial is running

Shantou, Guangdong

• Cancer Hospital, Shantou University Medical College — Shantou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Chuangzhen Chen, MD — Cancer Hospital, Shantou University Medical College
• Study coordinator: Yizhou Zhan, MD

Conditions Cervical Cancer; Neoadjuvant Chemotherapy; NACT; Locally Advanced Bulk Cervical Cancer; Chemoradiotherapy