Comparison of Nedaplatin and Cisplatin Concurrent with Radiotherapy in Treatment of Local-advanced Head and Neck Carcinoma: a phase II/III randomized trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900021439

Enrollment

Unknown

Registered

2019-02-21

Start date

2019-03-01

Completion date

Unknown

Last updated

2019-02-25

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

Conditions

head and neck squamous cell carcinoma

Interventions

study group:concurrent 7-week chemotherapy with nedaplatin after surgery

control group:concurrent 7-week chemotherapy with cisplatin after surgery

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) The primary tumor is oral cancer, oropharyngeal carcinoma,cancer of pharynx or laryngeal cancer stage ?-?b; (AJCC/UICC eighth Edition) (2)Surgical treatment, pathological diagnosis of squamous cell carcinoma, surgery within 66 days of simultaneous radiotherapy and chemotherapy; (3)Risk factors are defined as: ?Extracapsular invasion of lymph nodes ?positive margin of tumor ?= 2 lymph node metastasis (4)Male or non-pregnant, lactating female; 18-65 years of age; (5)No radiotherapy, chemotherapy or other antitumor therapy was given before the clinical trial began. (6)hematological examination WBC count = 4 × 1012 / L; Neutrophil count = 1. 5 × 1012 / L; Platelet count = 100 × 109 / L; Hemoglobin = 9 g / L; (7)Blood biochemical examination: Total bilirubin, AST,ALT = 2. 0 times the upper limit of normal value; Creatinine = 1.5 times the upper limit of normal value; (8)Functional status: 0 ~1 (ECOG); (9)Informed consent has been signed.

Exclusion criteria

Exclusion criteria: (1) Patients with recurrence and distant metastasis; (2) Having or present with other tumors whose primary location or histology is not the same as those assessed by this study. (3) The patient also suffers from other serious diseases that are not under control; (4) The patient is receiving other anti-cancer drugs or methods of treatment; (5) The patient does not comply or the researcher thinks that the patient is unable to complete the whole trial; (6) Heart, brain, lung and other important organ dysfunction.

Design outcomes

Primary

Measure	Time frame
2-year progression-free survival rate (PFS);	—

Secondary

Measure	Time frame
2-year local recurrence-free survival rate (LRFS);2-year overall survival rate (OS);2-year distant metastases-free survival rate (DMFS);acute and late toxic reaction;average length of stay (ALOS);life quality;	—

Countries

China

Contacts

Public ContactLiu Ying

Nan Fang Hosipital

59972644@qq.com+86 13711598096

Outcome results

None listed

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