Cervical gastric-type adenocarcinoma
Conditions
Interventions
Experimental group:Paclitaxel combined with platinum based concurrent chemoradiotherapy and adjuvant chemotherapy
Control group:Cisplatin monotherapy concurrent chemoradiotherapy
Sponsors
Women’s Hospital, School of Medicine, Zhejiang University.
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Pathologically confirmed cervical gastric-type adenocarcinoma. 2. Identified by standard evaluation as having at least one of the following risk factors: positive surgical margins, parametrial involvement, adnexal involvement, lymph node metastasis, tumor diameter >=4 cm, invasion of the outer third of the cervical stroma, or lymphovascular space invasion. Inclusion may be confirmed after discussion by two senior clinicians. 3. Medical history review and gynecological examination within 14 days prior to enrollment to confirm tumor size and FIGO staging. 4. Chest non-contrast CT, abdominal contrast-enhanced CT, or PET/CT performed within 30 days prior to enrollment. 5. Pelvic CT, MRI, or PET/CT performed within 30 days prior to enrollment. 6. ECOG performance status 0-1. 7. Age 18–65 years. 8. Laboratory tests (within 14 days prior to enrollment): • Hematologic function: • WBC >=3.5 ×10?/L (normal range) • Neutrophils >=1.5 ×10?/L • Platelets >=100 ×10?/L • Hemoglobin >=100 g/L (transfusion or other interventions acceptable) • Hepatic function: ALT/AST 60 mL/min (calculated via): CCr =[(140-age)×weight(kg)]/[72×Scr(mg/dL)]or[(140-age)×weight(kg)]/[0.818×Scr(µmol/L)] • Coagulation: INR <=1.5. 9. Women of childbearing potential must agree to use effective contraception throughout the study. 10. Signed informed consent prior to enrollment.
Exclusion criteria
Exclusion criteria: 1. Pathological types of cervical cancer excluding gastric-type adenocarcinoma, such as squamous cell carcinoma, adenosquamous carcinoma, undifferentiated carcinoma, small cell carcinoma, neuroendocrine carcinoma, sarcoma, etc. 2. Stage IVB disease. 3. History of prior invasive malignancies (except non-melanoma skin cancer). 4. Received systemic chemotherapy within the past 3 years. 5. Prior pelvic or abdominal radiotherapy that may result in overlap of radiation fields with current treatment. 6. Presence of distant metastases in other organs. 7. Severe active comorbidities including: 1) Unstable angina or congestive heart failure requiring hospitalization within the past 6 months 2) Transmural myocardial infarction within the past 6 months 3) Acute bacterial/fungal infection requiring intravenous antibiotics at enrollment 4) Exacerbated chronic obstructive pulmonary disease or other respiratory conditions requiring hospitalization or interfering with study participation 5) Hepatic dysfunction causing jaundice or coagulation disorders 6) Acquired immunodeficiency syndrome (confirmed AIDS diagnosis or suspected AIDS patients refusing HIV testing) 7) Other immunocompromised states (e.g., organ transplantation, prolonged glucocorticoid use) 8. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| The relationship between toxicity and the radiation dose/volume to organs at risk;Patterns of treatment failure;Overall survival;Incidence of acute/chronic toxicity;Quality of Life Assessment; | — |
Countries
China
Contacts
Public ContactQiu Tang
Women’s Hospital, School of Medicine, Zhejiang University.
Outcome results
None listed