Clinical trial · Observational
High Dose Rate Interstitial Brachytherapy With Three Dimensional Printing Template for Recurrent Gynecologic Tumors
Clinical Study on Pelvic Recurrence of Gynecologic Tumors After External Irradiation by Three Dimensional Printing Personalized Template Assisted With 192Ir High Dose Rate Interstitial Brachytherapy
NCT04127435CI-TRIAL-00041153unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a single-center study.Eligible patients will have histologically proven pelvic recurrence of cervical cancer after radiotherapy .
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- High-Dose-Rate 192Ir Brachytherapy
- description
- 1. All patients underwent computed tomography (CT) 3-5 days before surgery. The collimation is 2.5 mm and CT Planning System. 2. Delineation of the gross tumor volume (GTV) and adjacent organs at risk (OARs); 3. Determination of the needle tract of the implanted insertion direction, distribution, and depth. Then calculation of the dose distribution of the target volume and OARs. 4. Depending on B-TPS data, we establish a digital model for the individual template. 5. Local anesthesia or intraspinal anesthesia was induced in all patients. The three-dimensional printing noncoplanar templates (3D-PNCT) was placed on the surface of the treatment area of the patient. The 3D-PNCT was aligned accurately with the outer-contour features. Through the guide hole of the 3D-PNCT, we inserted to pre-planned depths. 6. Delineation of the GTV and design planning . 7. Connect the source tube and 192Ir high dose rate interorganizational brinotherapy 8. At the end pressed to stop bleeding.
Primary outcomes (2)
- measure
- Local Progression Free Survival
- timeFrame
- 2 years
- description
- Local progression free survival was defined as the time from the implantation of the treatment to the treatment of local tumor progression.
- measure
- Tumor Response Rate
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.