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A study on Clinical Target Volume of 3D printed template-assisted CT-guided radioactive iodine 125 seed implantation for pelvic recurrent cervical carcinoma after external radiotherapy

A study on Clinical Target Volume of 3D printed template-assisted CT-guided radioactive iodine 125 seed implantation for pelvic recurrent cervical carcinoma after external radiotherapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000040563
Enrollment
Unknown
Registered
2020-12-02
Start date
2020-12-01
Completion date
Unknown
Last updated
2021-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pelvic recurrent cervical carcinoma

Interventions

Arm 1:radioactive iodine 125 seed implantation with CTV from GTV+3mm
Arm 2:radioactive iodine 125 seed implantation with CTV from GTV+6mm

Sponsors

Peking University Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Confirmed by pathology; (2) There are lesions that can be evaluated by imaging, and the largest tumor diameter is =1cm and =7cm; (3) Those who have received external radiotherapy in the past and are not suitable for re-external radiotherapy or who refuse to re-external radiotherapy; (4) Not suitable for surgery or refuse surgery; (5) Age = 18 years old; (6) KPS=60 points; (7) Sufficient blood reserve: white blood cell count =3×109/ml; granulocyte count =1.5×109/ml; hemoglobin =90g/L; platelet >50×109/L; (8) Good liver function: serum total bilirubin concentration=1.5×ULN; ALT or AST=3×ULN; (9) Good renal function: serum creatinine value=1.5×ULN, urine protein 3 months;

Exclusion criteria

Exclusion criteria: (1) Cannot tolerate anesthesia; (2) Cannot tolerate puncture; (3) There is no suitable puncture path; (4) The preoperative plan design cannot meet the clinical treatment requirements; (5) Those with serious bleeding tendency, such as platelets 18s, prothrombin activity <40%, and anticoagulation therapy and/or antiplatelet aggregation drugs in seed implantation therapy Stopped before <1 week; (6) Skin ulcers caused by tumors; (7) There are serious complications (such as severe hypertension, diabetes, etc.) that lead to clinical risks; (8) Patients with active infectious diseases, severe trauma and stroke; (9) People with mental disorders; (10) Pregnant or lactating women; (11) Patients who are allergic to iodine contrast agents.

Design outcomes

Primary

MeasureTime frame
Local control time;

Secondary

MeasureTime frame
Dosimetry;Objective response rate;Disease control rate;Pain relief rate;Treatment-related toxicity;Overall survival;Quality of life;

Countries

China

Contacts

Public ContactWang Junjie

Peking University Third Hospital

junjiewang_edu@sina.com+86 13701076310

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026