Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The First Affiliated Hospital of Xiamen University | OTHER |
| Heilongjiang Provicial Hospital | OTHER |
| Liaoning Cancer Hospital & Institute | OTHER |
Not provided
Not provided
Not provided
This study aims to establish a prospective cohort of locally advanced cervical adenocarcinoma to provide a better way to monitor its efficacy and provide precise treatment. The key problems to be solved are as follows:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: the local treatment group | Experimental |
| |
| Group B: the systemic treatment group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radiotherapy | Radiation | The surgical method is determined by the gynecological oncologist, including total hysterectomy, pelvic exenteration, or radical total hysterectomy. The specific surgical choice needs to be comprehensively judged based on the patient's residual tumor location, size, and other complications. Supplementary radiotherapy is mainly image-guided brachytherapy ± external irradiation. The irradiation range and dose must be comprehensively considered based on the location and size of the residual lesions. The best local treatment plan is jointly determined by gynecological oncologists and radiotherapists. |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor control rate | Tumor control rate among patients with residual cervical tumors in the two groups 3 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival | The time from randomization to the occurrence of disease recurrence or death from any cause within 2 years was determined based on the time of the first event. If no such event occurred, the time was determined to the last follow-up. | 2-year progression-free survival |
| overall survival |
Not provided
Inclusion Criteria:
Exclusion Criteria:
f) Serious diseases that may significantly affect compliance with clinical trials, such as unstable heart disease, kidney disease, chronic hepatitis, poorly controlled diabetes, and mental illness that require treatment; g) Other situations that the investigator believes are not suitable for participation in this clinical study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100730 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D003131 | Combined Modality Therapy |
Not provided
Not provided
| Obstetrics and Gynecology Hospital of Zhejiang University |
| UNKNOWN |
| Luohe Central Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Systemic treatment | Drug | Systemic treatment regimens include chemotherapy ± targeted therapy ± immunotherapy. According to the NCCN Guidelines (2024.V2), the first-line chemotherapy regimen for persistent, recurrent, or metastatic cervical cancer is preferably carboplatin/paclitaxel and cisplatin/paclitaxel. The addition of immunotherapy can be determined based on the PD-L1 expression level. The specific chemotherapy regimen will be determined by the gynecological oncologist based on the residual tumor site, the number of lesions, and other complications. In addition, if the patient's pathological results indicate HER2 positivity or the genetic test results show PIK3CA mutation, targeted therapy, such as neratinib or apelisimab, can be considered as a second-line regimen after the first-line chemotherapy regimen progresses. |
|
The time interval from randomization to death from any cause within 2 years, or if there was no death, to the last follow-up time |
| 2-year overall survival rate |