Cervical Cancer
Conditions
Brief summary
This is a single-center study.Eligible patients will have histologically proven pelvic recurrence of cervical cancer after radiotherapy .
Detailed description
The results of treatment, examination and follow-up of patients with recurrent cervical cancer after radiotherapy who recieved imaging guided three dimensional printing personalized template assisted with 192Ir high dose rate interorganizational braided therapy were statistically analyzed .
Interventions
None listed
Sponsors
Peking University Third Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients with histologically confirmed pelvic recurrence of cervical cancer. * Age ≥ 18 years and ≤ 75 years. * Previous accept pelvic radiotherapy; * Karnofsky ≥60； * Patients reject or cannot tolerate surgery; * Received 192Ir high dose rate intertissue salvage therapy; * Ultrasound guidance or computed tomography guidance; * Regular review and follow-up.
Exclusion criteria
* Patients participated in clinical trials of other drugs within four weeks; * The patient had a previous history of bleeding, and any bleeding event with severity rating of CTCAE5.0 or above occurred within 4 weeks prior to screening; * There are any puncture taboos. * Patients with severe cardiovascular and cerebrovascular diseases. * Unable to treat as planned. * Patients lack major indicators and cannot participate in post-treatment review and follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local Progression Free Survival | 2 years | Local progression free survival was defined as the time from the implantation of the treatment to the treatment of local tumor progression. |
| Tumor Response Rate | three months | Tumor size changes were monitored using CT. According to the solid tumor treatment efficacy evaluation standard RECIST, evaluation results including complete response, partial response, stable disease, and progression disease.Tumor response rate was complete response rate plus partial response rate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 2 years | Overall survival was defined as the time from the implantation of the treatment to the death of any cause. |
| Safety and Tolerability | 2 years | Number of participants with treatment-related acute adverse events were evaluated according to RTOG acute radiation injury grading standards; Number of participants with treatment-related late adverse events were evaluated according to RTOG/ EORTC advanced radiation injury grading schemes. |
Countries
China
Contacts
Primary ContactPing Jiang, MD
Backup ContactJunjie Wang, MD, PhD
Outcome results
None listed