Cervical Cancer
Conditions
Interventions
omitting brachytherapy:For patients with locally advanced cervical cancer who achieve complete response (CR) of cervical lesions after induction chemotherapy, brachytherapy can be omitted after concur
Sponsors
First Affiliated Hospital of Sun Yat-sen university
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed cervical squamous cell carcinoma. 2. Age >=18 years. 3. Newly diagnosed Stage IB-IVA (FIGO 2018 staging). 4. ECOG performance status 0-1. 5. Achievement of clinical complete response (CR) after induction therapy (any regimen permitted), confirmed by both of the following: Imaging: Preferred method: Contrast-enhanced MRI with DWI. Alternative methods: Contrast-enhanced CT or PET-CT/MRI. Gynecological examination. (Note: Complete response in metastatic lymph nodes is not required.) 6. Adequate organ function within 7 days prior to treatment: Hematological: a. ANC >=1.5×10?/L. b. Platelets >=80×10?/L. Biochemical: a. TBIL 45 mL/min (Cockcroft-Gault formula). 7. Signed informed consent for study participation.
Exclusion criteria
Exclusion criteria: 1. Patients with other histological types of cervical cancer, such as adenocarcinoma, adenosquamous carcinoma, neuroendocrine carcinoma, sarcoma, etc. 2. No prior induction therapy OR failure to achieve complete response in the cervical lesion after induction therapy. 3. Evidence of distant metastasis, including inguinal lymph node involvement. 4. History of total hysterectomy (removal of uterine corpus and cervix). (Note: History of subtotal hysterectomy or cornual resection, which preserve the cervix, is allowed.) 5. Anatomical abnormalities or tumor geometry that preclude the use of brachytherapy. 6. Other active malignancies within 2 years prior to enrollment, except for locally curable cancers with confirmed cure, such as cutaneous squamous cell carcinoma, basal cell carcinoma, superficial bladder cancer, or breast carcinoma in situ. 7. Presence of clinically significant bilateral hydronephrosis deemed by the investigator as unrelievable by nephrostomy or ureteral stenting. 8. Patients with active hepatitis B (HBsAg positive and HBV DNA >1000 IU/mL) or active hepatitis C. (*Note: Inactive or asymptomatic HBV carriers on stable treatment with HBV DNA = II. b) Severe arrhythmias requiring long-term medical intervention. (Asymptomatic atrial fibrillation with stable ventricular rate is allowed.) c) Cerebrovascular accident (CVA) within 6 months prior to randomization. d) Left ventricular ejection fraction (LVEF) < 50%. 12. Major surgical procedures (as determined by the investigator), open biopsy, or significant traumatic injury within 4 weeks prior to enrollment; OR planned elective major surgery during the study period. (Note: Systematic pelvic/para-aortic lymphadenectomy performed for diagnostic purposes is allowed.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year Progression-Free Survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, OS; | — |
Countries
China
Contacts
Public ContactYufeng Ren
First Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed