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A phase II prospective randomized controlled clinical trial of 3D printed template-assisted CT guided I125 seed implantation combined with chemotherapy versus chemotherapy alone in the treatment of noncentral recurrent cervical cancer after radiotherapy

A phase II prospective randomized controlled clinical trial of 3D printed template-assisted CT guided I125 seed implantation combined with chemotherapy versus chemotherapy alone in the treatment of noncentral recurrent cervical cancer after radiotherapy

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200055123
Enrollment
Unknown
Registered
2022-01-01
Start date
2022-01-01
Completion date
Unknown
Last updated
2023-01-09

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

Conditions

Cervical cancer

Interventions

Seed implantation combination chemotherapy group:Seed implantation combination chemotherapy
Chemotherapy group:Chemotherapy alone

Sponsors

Xiang'an Hospital of Xiamen University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-70 years. 2. Karnofsky score (Karnofsky, KPS) >= 70 points. 3. Pathologically diagnosed as squamous cell carcinoma. 4. There is only one recurrent lesion with a diameter of <=7cm. 5. Imaging confirmed non-central recurrence. 6. Received pelvic external beam radiotherapy in the past. 7. No obvious contraindications to radiotherapy and chemotherapy. 8. Patients and their family members understand the whole process of disease diagnosis and treatment, and voluntarily sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Associated with liver, lung, brain, bone and other organs or other distant metastases. 2. Associated with mental illness, severe medical disease, bleeding tendency or local acute infection. 3. History of other malignant tumors in addition to cervical cancer within 5 years before enrollment. 4. Are pregnant or breastfeeding.

Design outcomes

Primary

MeasureTime frame
Objective response rate;

Secondary

MeasureTime frame
Local regional progression-free survival;Progression-free survivall;Overall survival;Quality of life;Acute toxicities and late toxicities;

Countries

China

Contacts

Public ContactLiang Yuqin

Xiang'an Hospital of Xiamen University

liangyuqin0311@163.com+86 15521133411

Outcome results

None listed

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