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A study for comparing efficacy and safety of lobaplatin versus cisplatin concurrent chemoradiotherapy for cervical cancer

A study for comparing efficacy and safety of lobaplatin versus cisplatin concurrent chemoradiotherapy for cervical cancer

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035449
Enrollment
Unknown
Registered
2020-08-11
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-08-17

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

Conditions

Cervical cancer

Interventions

Sponsors

Shanghai Jiao Tong University Affliated Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Cervical cancer patients diagnosed by pathology for the first time; 2. According to the 2018 FIGO cervical cancer staging for patients with stage IB-?a; 3. Age from 18 to 70 years old; 4. ECOG general condition score 0-2, weight loss less than 10% within 6 months, can tolerate radiotherapy and chemotherapy; 5. No other second primary cancer within 5 years; 6. It is confirmed that there is no distant metastasis by MRI or CT, chest X-ray, B-ultrasound, etc.; 7. No other serious medical complications such as coronary heart disease, hypertension, tuberculosis, etc.; 8. Non-pregnancy and lactation period; 9. Those who are expected to survive more than 12 months; 10. Laboratory examination before radiotherapy and chemotherapy meets the following conditions: (1) Liver function: total bilirubin=80 mL/min; (3) Blood function: absolute neutrophil count (ANC)>=2x10^9/L, platelet count>=100x10^9/L and hemoglobin>=9g/dL. 11. The subject agrees and signs the informed consent form (if the subject is not capable of judgment, his legal guardian is required to sign the informed consent form).

Exclusion criteria

Exclusion criteria: 1. Accompanied by severe uncontrollable infection; 2. There are factors affecting administration, distribution, metabolism, excretion, etc., such as mental disorders, central nervous system abnormalities, chronic diarrhea, ascites, pleural fluid, etc.; Simultaneously accept experimental treatments of other clinical studies (those who are in the treatment period of clinical studies or participate in other drug clinical trials within 30 days); 3. Those who have used immunosuppressive agents for a long time after organ transplantation or who have used immunostimulants in combination; 4. Those who have severe heart, lung, liver and kidney dysfunction such as decompensated heart, lung, kidney, liver and other major organ dysfunction, failure or poor blood sugar control, cannot tolerate radiotherapy and chemotherapy; 5. Patients with cognitive dysfunction or poor compliance with radiotherapy and chemotherapy as determined by the researcher.

Design outcomes

Primary

MeasureTime frame
Renal function;

Secondary

MeasureTime frame
Local recurrence;

Countries

China

Contacts

Public ContactJie Fu

Department of Radiation Oncology, Shanghai Jiao Tong University Affliated Sixth People's Hospital

fujie74@sjtu.edu.cn+86 18930173972

Outcome results

None listed

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