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

March 13, 2025 updated by: Qiu Tang, Women's Hospital School Of Medicine Zhejiang University

A Multicenter Randomized Study Comparing Paclitaxel and Platinum-based Concurrent Chemoradiotherapy With Short-term Adjuvant Chemotherapy Versus Platinum-based Monotherapy Concurrent Chemoradiotherapy in Patients With Postoperative Cervical Gastric-type Adenocarcinoma With High-risk Factors for Recurrence.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

238

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental arm
Drug: paclitaxel and platinum
After the start of External Beam Radiation Therapy (EBRT), paclitaxel (150-175 mg/m2) or paclitaxel (albumin-bound) 222-260 mg/m2 + cisplatin (60-75 mg/m2) or carboplatin [Area Under Curve (AUC) = 4-5], Q3W (every 3 weeks is a dosing cycle), administered on the first day of each cycle, for a total of 4 cycles. Adjuvant chemotherapy started 4 weeks after the end of external irradiation therapy, and chemotherapy-related adverse reactions dropped to grade 2 or below before chemotherapy began. If not met, it can be postponed for 2 weeks.
Active Comparator: Control arm
Drug: platinum
During EBRT, cisplatin (40 mg/m2) or carboplatin (AUC = 2) was used for concurrent chemotherapy once a week for a total of 5 times. On the day of cisplatin infusion, radiotherapy should be performed after cisplatin or carboplatin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
2-year progression-free survival (PFS)
Time Frame: 2 year
2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival rate
Time Frame: 2 year
2 year
Disease failure pattern
Time Frame: 2 year
The pattern of disease failure will be assessed by the site and number of recurrences or distant metastases.
2 year
Incidence of acute/chronic toxicity
Time Frame: 2 year
2 year
Quality of life assessment
Time Frame: 2 year
Quality of life assessment (time node: 2 years). The patients'quality of life will be assessed using the Quality of Life Questionnaire-Core 30 (QLQ-C30) scale.
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Women's Hospital School Of Medicine Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

March 5, 2025

First Submitted That Met QC Criteria

March 5, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 13, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-20250032-R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe