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

Last updated: March 13, 2025
Sponsor: Women's Hospital School Of Medicine Zhejiang University
Overall Status: Active - Not Recruiting

Phase

3

Condition

Adenocarcinoma

Vaginal Cancer

Cervical Cancer

Treatment

paclitaxel and platinum

platinum

Clinical Study ID

NCT06870565
IRB-20250032-R
  • Ages 18-65
  • Female

Study Summary

Background: Gastric-type endocervical adenocarcinoma (G-EAC) is a new classification of cervical mucinous carcinoma. G-EAC is a unique human papillomavirus unrelated adenocarcinoma that can be distinguished from typical endocervical adenocarcinoma (UEA). In China, adjuvant therapy for cervical cancer after surgery includes not only radiotherapy (RT) or concurrent chemoradiotherapy (CCRT), but also chemotherapy in many cases. However, no previous prospective study has analyzed the adjuvant therapy of G-EAC. This study is the first randomized phase III trial, which aims to recommend better adjuvant treatment options for G-EAC patients at high risk of recurrence in China, in order to better optimize and personalize patient care and improve recurrence-free survival and overall survival.

Methods: This trial is a prospective, multicenter study led by the Department of Radiotherapy, Affiliated Hospital of Obstetrics and Gynecology, Zhejiang University. Recruitment will begin in February 2025, and it is expected that 238 patients with postoperative cervical gastric adenocarcinoma with high risk of recurrence will be recruited from 16 clinical centers in China. Patients will be randomly assigned to the experimental group or the control group in a 1:1 ratio. The experimental group will receive paclitaxel combined with platinum-based concurrent chemoradiotherapy and short-term adjuvant chemotherapy, and the control group will receive the current standard treatment regimen, i.e., platinum-based concurrent chemoradiotherapy, without adjuvant chemotherapy. The primary endpoint of the study is the 2-year progression-free survival, and the secondary endpoints are disease treatment failure pattern, overall survival rate, acute/chronic toxicity incidence, and quality of life assessment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Pathologically confirmed Gastric-type endocervical adenocarcinoma;

  2. Based on standard examination procedures, it is determined that one of the followingrisk factors is combined: positive margin, positive paracervical involvement,adnexal involvement, positive lymph nodes, tumor diameter ≥ 4cm, infiltration of theouter 1/3 of the cervical stroma, and vascular tumor thrombus. The specificinclusion can be discussed by two senior clinical doctors;

  3. Medical history inquiry and gynecological examination must be performed within 14days before enrollment to confirm the size of the tumor and International Federationof Gynecology and Obstetrics (FIGO) stage;

  4. Chest Computed Tomography (CT) plain scan, abdominal enhanced CT scan, or PositronEmission Tomography (PET)/CT examination within 30 days before enrollment;

  5. Pelvic CT, Magnetic Resonance Imaging (MRI) or PET/CT examination within 30 daysbefore 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 bonemarrow, liver function, and kidney function tests are performed:

  9. White blood cell (WBC) ≥ 3.5 x 10E9/L (normal range)

  10. Neutrophils ≥ 1.5 x 10E9/L;

  11. Platelets ≥ 100 x 10E9/L;

  12. Hemoglobin ≥ 100 g/L (transfusion or other methods are acceptable)

  13. 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.

  14. Renal function is within the normal range: creatinine clearance rate (CCr) > 60ml/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

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 ofirradiation 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 thepast 6 months 2) Transmural myocardial infarction in the past 6 months 3) Acutebacterial or fungal infection requiring intravenous antibiotic treatment at the timeof registration 4) Exacerbation of chronic obstructive pulmonary disease or otherrespiratory diseases requiring hospitalization or hindering the study 5) Jaundice orcoagulation disorder caused by poor liver function 6) Acquired immunodeficiencydisease (Patients diagnosed with Acquired Immune Deficiency Syndrome (AIDS), orpatients suspected of having AIDS who refuse HIV testing); 7) Otherimmunocompromised states (e.g. organ transplantation, long-term use ofglucocorticoids); 8. Pregnant women, breastfeeding women.

Study Design

Total Participants: 238
Treatment Group(s): 2
Primary Treatment: paclitaxel and platinum
Phase: 3
Study Start date:
March 01, 2025
Estimated Completion Date:
December 31, 2030