Skip to content

Concurrent Chemoradiotherapy with Nedaplatin Versus Cisplatin in Patients with Stage IIB-IVA Cervical Cancer: A prospective, Parallel Assignment, Randomized Controlled, Open-label, Multicenter, Non-inferiority, Phase III Clinical Trial

Concurrent Chemoradiotherapy with Nedaplatin Versus Cisplatin in Patients with Stage IIB-IVA Cervical Cancer: A prospective, Parallel Assignment, Randomized Controlled, Open-label, Multicenter, Non-inferiority, Phase III Clinical Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900020527
Enrollment
Unknown
Registered
2019-01-06
Start date
2019-02-01
Completion date
Unknown
Last updated
2019-09-02

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

Conditions

Cervical cancer

Interventions

Sponsors

The First Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Pathologically proven primary cervical cancer IIB-IVA with squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma(FIGO 2018); 2. Patients who have not received any previous radiation, chemotherapy or surgery; 3. Female aged 18-70 years old; 4. Adequate liver functions: Total bilirubin /= 80 mL/min; 6. Adequate hematologic functions: Absolute neutrophil count (ANC) >/= 2,000/mcl; Platelets >/= 100,000/mcl; Hemoglobin >/= 9g/dL; 7. Patients with other severe disease (heart, lung); 8. Performance status 0, 1, 2 (refer to the appendix); 9. Patients must have signed an approved informed consent and authorization permitting release of personal health information.

Exclusion criteria

Exclusion criteria: 1. Patients with septicemia or severe infection; 2. Patients with intestinal obstruction or gastrointestinal bleeding; 3. Patients in pregnant or lactation period; 4. Patients whose circumstances do not permit completion of the study or the required follow-up; 5. Patients with renal abnormalities requiring modification of radiation field (pelvic kidney, renal transplant, etc.); 6. Acquiring other experimental therapy (in the period of other trail treatment); 7. Patients with a history of other invasive malignancies before enrollment; 8. Distant metastasis was found before treatment; 9. Known allergy to chemotherapy drugs that may be used; 10. Factors affecting drug administration, distribution, metabolism and excretion, such as mental abnormalities, central nervous system abnormalities, chronic diarrhea, ascites, pleural effusion, etc; 11. Disagree to sign the informed consent.

Design outcomes

Primary

MeasureTime frame
PSF;OS;Treatment Response Rate;Safety and Toxicities Assessment;

Countries

China

Contacts

Public ContactYong Chen

Department of Radiation Oncology, The First Affiliated Hospital of Sun Yat-sen University

chenyong@mail.sysu.edu.cn+86 13826266676

Outcome results

None listed

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