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Concurrent Chemoradiotherapy With Nedaplatin Versus Cisplatin in Patients With Stage I-IIA Cervical Cancer Who Previously Underwent Surgery: 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 I-IIA Cervical Cancer Who Previously Underwent Surgery: 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
ChiCTR1800020280
Enrollment
Unknown
Registered
2018-12-22
Start date
2019-02-01
Completion date
Unknown
Last updated
2019-02-18

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

Conditions

Cervical cancer

Interventions

1:Nedaplatin
2:Cisplatin

Sponsors

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

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Pathologically proven primary cervical cancer I-IIA with squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma initially treated with a standard radical hysterectomy with pelvic lymphadenectomy; 2. Patients with the following characteristics after surgery: Positive lymph node Pathological diagnosis of deep muscular involvement Vascular tumor emboli Tumor diameter >/= 4 cm Para-uterine tissue is involved Surgical margin positive or vaginal margin positive 3. Patients who have not received any previous radiation, chemotherapy or surgery; 4. Female aged 18-65 years old; 5. Adequate liver functions: Total bilirubin /= 80 mL/min; 7. Adequate hematologic functions: Absolute neutrophil count (ANC) >/= 2,000/mcl; Platelets >/= 100,000/mcl; hemoglobin >/= 9g/dL; 8. Patients with other severe disease (heart, lung); 9. Performance status 0, 1, 2 (refer to the appendix); 10. 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.

Design outcomes

Primary

MeasureTime frame
PFS;—

Secondary

MeasureTime frame
OS;Treatment Response Rate;—

Countries

China

Contacts

Public ContactYong Chen

The First Affiliated Hospital, 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