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Phase I single-arm study of interstitial brachytherapy for pelvic nodal metastases follow chemoradiotherapy in cervical cancer

Phase I single-arm study of interstitial brachytherapy for pelvic nodal metastases follow chemoradiotherapy in cervical cancer

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064309
Enrollment
Unknown
Registered
2022-10-02
Start date
2022-10-01
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

cervical cancer

Interventions

None listed

Sponsors

Affiliated Hospital of Southwest Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Patient age range between 18 - 70 years old; 2. Pathological diagnosis included clear cervical squamous carcinoma, adenocarcinoma, or adenosquamous carcinoma; 3. Pelvic lymph node metastasis was confirmed histologically, the tumor was longer than 2cm, and the number was limited to 3 lesions. doctors believe that the metastatic lymph node is adaptive for interstitial brachytherapy; 4. These patients were classified into stage IIIC, and IVA by FIGO stage and had no surgery; 5. Those patients are willing to receive invasive interstitial brachytherapy; 6. ECOG:0-1; 7. Experimental examination should be carried out within 14 days before enrollment, including bone marrow, liver, and kidney function testing: (1) Leukocyte was greater than 3.5 x 10^9 / L; platelet was greater than 100 x 10^9 / L; hemoglobin-vb was greater than 100g / L (acceptable using blood transfusion or other methods); (2) Liver function is in the normal range: gluthyltransferase and glutgrass transaminase were below 1.5 times the upper limit, alkaline phosphatase was below 2.5 times the upper limit, and bilirubin was below the upper normal value; (3)Renal function is within the normal range: creatinine clearance (CCr) was greater than 60 ml/min. The calculation formula is as follows, CCr= (140-age) x Weight (kg) / [72 Scr x (mg/dl)] or CCr= [(140-age)*Weight (kg)] / [0.818 Scr *(umol/L)], Prothrombin international ratio (INR) was less than or equal to 1.5; 8. Fertile women must agree to take effective contraception throughout the treatment study period; 9. Patients must sign an informed consent form before enrollment.

Exclusion criteria

Exclusion criteria: 1. Other pathological types of cervical malignant tumors, such as undifferentiated cancer, neuroendocrine cancer, sarcoma; 2. Severe bleeding or active bleeding performance; 3. The patient has accepted neoadjuvant chemotherapy; 4. The patient has a history of pelvic or abdominal radiotherapy; 5. Allergy or contraindications to the drugs needed to be used in this study; 6. The patient was combined with the following severely active concurrent diseases: such as unstable angina in the past 6 months, congestive heart failure requiring hospitalization; myocardial infarction in the last 6 months; acute bacterial or fungal infection requiring intravenous antibiotics, antifungal treatment; deteriorating chronic obstructive pulmonary disease or other respiratory diseases requiring hospitalization or obstructing the study; liver dysfunction leads to jaundice or coagulation disorders; 7. The patient has blood coagulation dysfunction; 8. Uncontrollable hypertension and diabetes; 9. The patient was combined with other malignant tumors; 10. The patient was combined with AIDS, and other immunocompromised patients, such as organ transplantation, and long-term use of glucocorticoids; 11. Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
;;

Countries

China

Contacts

Public ContactZhenhua Zhang

Affiliated Hospital of Southwest Medical University

20185196@qq.com+86 18982715266

Outcome results

None listed

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