Gynecologic tumors
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Histopathologically confirmed squamous cell carcinoma of the cervix, adenocarcinoma, adenosquamous carcinoma, age: 18-75 years, ECOG PS 0-1, CT, MRI, or PET-CT confirmed patients with treatment-naïve cervical cancer stage IIB-IVA (FIGO2018) - non-surgical group, tumor samples can be obtained for biomarker evaluation. Squamous cell carcinoma of the cervix, adenocarcinoma, or adenosquamous carcinoma, FIGO (International Federation of Obstetrics and Gynecology) stage IB-VIA, requires radical chemoradiotherapy. Patients with endometrioid adenocarcinoma who underwent radical hysterectomy + pelvic lymph node dissection, cervical scales, glands, and adenoscales and patients with endometrioid adenocarcinoma who underwent extrafascial or subextensive and extensive uterine double adnexectomy + pelvic lymph node dissection - surgery group. The expected survival time is = 6 months, and the patient can understand and sign the informed consent form (when the subject is incapacitated, the guardian will sign on behalf of the patient), and the function of major organs can meet the requirements of chemotherapy and radiotherapy.
Exclusion criteria
Exclusion criteria: Previous chemotherapy or radiotherapy for pelvic tumors, locally recurrent cervical cancer, active Crohn's disease or ulcerative colitis, history of allergy or hypersensitivity to cisplatin or carboplatin, paclitaxel, history of difficulty or inability to take or absorb oral medications, diagnosis of other malignant diseases other than cervical cancer and endometrial cancer within 5 years prior to enrollment (excluding radically cured basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/ or carcinoma in situ that has undergone radical resection), distant metastases confirmed by imaging or biopsy, previous pelvic radiotherapy, pregnant or lactating women, claustrophobia syndrome;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical control rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Acute toxicity;Late toxicity;Disease-free survival;Overall survival rate;Distant metastasis-free survival;Overall quality of life of the QLQ-C30;Quality of life for QLQ-CR29; | — |
Countries
China
Contacts
Shandong Provincial Cancer Hospital