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Prospective, single-arm clinical study of the safety and effectiveness of SBRT technology in the treatment of locally advanced cervical cancer with the aid of cervical fixators

Prospective, single-arm clinical study of the safety and effectiveness of SBRT technology in the treatment of locally advanced cervical cancer with the aid of cervical fixators

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039836
Enrollment
Unknown
Registered
2020-11-12
Start date
2020-11-11
Completion date
Unknown
Last updated
2021-02-22

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

Conditions

cervical cancer

Interventions

SBRT group:SBRT technique assisted by cervical fixator

Sponsors

Wuhan University Renmin Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1) Patients with locally advanced cervical cancer in stage IB2 -IVA (2018 FIGO staging); 2) ECOG 0-1 level; life expectancy> 6 months; 3) 18-70 years old; 4) No chemotherapy was used before selection; 5) Complete standard pelvic external radiation therapy; 6) No surgical treatment; 7) No serious allergy history; 8) Hemoglobin >= 100 g/L, WBC >= 3.5 x 10^9/L, neutrophils >= 1.5 x 10^9/L, platelets >= 100 x 10^9/L; CR <= 1.5 times the upper limit of normal, TB <= 2.5 times the upper limit of normal, AST and ALT <= 2.5 times the upper limit of normal, AKP <= 2.5 times the upper limit of normal; 9) Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Those who cannot be followed up; 2) There are distant metastases such as visceral metastasis; 3) Those who have serious medical or psychiatric diseases that cannot be treated as prescribed by the doctor; 4) Severe infections are in active stage or under clinical control; 5) The external radiation does not reach the minimum therapeutic dose.

Design outcomes

Primary

MeasureTime frame
ORR;Recent adverse reactions;

Secondary

MeasureTime frame
DCR;PFS;OS;Long-term toxic and side effects;

Countries

China

Contacts

Public ContactXiming Xu

Wuhan University Renmin Hospital

78316825@qq.com+86 13707120651

Outcome results

None listed

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