Comparative Study of Adjuvant Therapy for Postoperative Cervical Gastric-type Adenocarcinoma

Launched by WOMEN'S HOSPITAL SCHOOL OF MEDICINE ZHEJIANG UNIVERSITY · Mar 5, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the best treatment options for women who have undergone surgery for a specific type of cervical cancer called gastric-type endocervical adenocarcinoma (G-EAC). The goal is to find out if a new combination of chemotherapy and radiation works better than the current standard treatment, which includes only radiation and chemotherapy. Approximately 238 women aged 18-65 who have been diagnosed with high-risk G-EAC will be invited to participate. Eligible participants must have had their cancer confirmed by a doctor and show certain risk factors that might make their cancer more likely to return.

If you join the trial, you will be randomly assigned to one of two groups: one group will receive the new treatment (a combination of chemotherapy and radiation), while the other group will receive the standard treatment. Throughout the study, your health and quality of life will be monitored. This trial is important because it aims to help doctors provide better care and improve the chances of patients living cancer-free after treatment.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Pathologically confirmed Gastric-type endocervical adenocarcinoma;
• • 2. Based on standard examination procedures, it is determined that one of the following risk factors is combined: positive margin, positive paracervical involvement, adnexal involvement, positive lymph nodes, tumor diameter ≥ 4cm, infiltration of the outer 1/3 of the cervical stroma, and vascular tumor thrombus. The specific inclusion can be discussed by two senior clinical doctors;
• • 3. Medical history inquiry and gynecological examination must be performed within 14 days before enrollment to confirm the size of the tumor and International Federation of Gynecology and Obstetrics (FIGO) stage;
• • 4. Chest Computed Tomography (CT) plain scan, abdominal enhanced CT scan, or Positron Emission Tomography (PET)/CT examination within 30 days before enrollment;
• • 5. Pelvic CT, Magnetic Resonance Imaging (MRI) or PET/CT examination within 30 days before enrollment;
• • 6. General condition score 0-1 points;
• • 7. Age 18-65 years old;
• 8. Laboratory examinations must be performed within 14 days before enrollment, and bone marrow, liver function, and kidney function tests are performed:
• • 1. White blood cell (WBC) ≥ 3.5 x 10E9/L (normal range)
• • 2. Neutrophils ≥ 1.5 x 10E9/L;
• • 3. Platelets ≥ 100 x 10E9/L;
• • 4. Hemoglobin ≥ 100 g/L (transfusion or other methods are acceptable)
• • 5. Liver function is within the normal range: alanine aminotransferase (ALT), aspartate aminotransferase (AST) \< 1.5 times the upper limit of normal, alkaline phosphatase (ALP) \< 2.5 times the upper limit of normal, bilirubin \< upper limit of normal.
• • 6. Renal function is within the normal range: creatinine clearance rate (CCr) \> 60 ml/min.
• • Calculation formula: CCr=(140-age)×weight (kg)/\[72×Scr (mg/dl)\] or CCr=\[(140-age)×weight (kg)\]/\[0.818×Scr (umol/L)\] g) International prothrombin ratio (INR) ≤ 1.5 9. Women of childbearing age must agree to take effective contraceptive measures during the entire treatment study; 10. Patients must sign an informed consent form before enrollment;
• Exclusion Criteria:
• • 1. Pathological types of non-gastric adenocarcinomas such as squamous cell carcinoma, adenosquamous carcinoma, undifferentiated carcinoma, small cell carcinoma, neuroendocrine carcinoma, and sarcoma of cervical cancer;
• • 2. Stage IVB;
• • 3. Previous invasive malignant tumors: excluding non-malignant melanoma skin cancer;
• • 4. Systemic chemotherapy in the past 3 years;
• • 5. Previous history of pelvic or abdominal radiotherapy, which may cause overlap of irradiation field for this radiotherapy;
• • 6. Distant metastatic lesions in other organs;
• 7. The following serious active concurrent diseases:
• • 1) Unstable angina and/or congestive heart failure requiring hospitalization in the past 6 months 2) Transmural myocardial infarction in the past 6 months 3) Acute bacterial or fungal infection requiring intravenous antibiotic treatment at the time of registration 4) Exacerbation of chronic obstructive pulmonary disease or other respiratory diseases requiring hospitalization or hindering the study 5) Jaundice or coagulation disorder caused by poor liver function 6) Acquired immunodeficiency disease (Patients diagnosed with Acquired Immune Deficiency Syndrome (AIDS), or patients suspected of having AIDS who refuse HIV testing); 7) Other immunocompromised states (e.g. organ transplantation, long-term use of glucocorticoids); 8. Pregnant women, breastfeeding women.