Skip to content

Many west los platinum vs. cisplatin plus he induction chemotherapy plus los platinum VS cisplatin chemoradiation in the treatment of locally advanced nasopharyngeal carcinoma efficacy and safety of prospective, multicenter, randomized, controlled phase II clinical study

Many west los platinum vs. cisplatin plus he induction chemotherapy plus los platinum VS cisplatin chemoradiation in the treatment of locally advanced nasopharyngeal carcinoma efficacy and safety of prospective, multicenter, randomized, controlled phase II clinical study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IIR-17013112
Enrollment
Unknown
Registered
2017-10-25
Start date
2017-11-01
Completion date
Unknown
Last updated
2017-12-18

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

Conditions

Nasopharyngeal carcinoma

Interventions

1:los platinum
2:cisplatin plus he induction chemotherapy plus los platinum
3:cisplatin chemoradiotherapy

Sponsors

Jiangsu Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Between the ages of 18 and 60, male and female; 2. Pathologically confirmed differentiated non-keratinized and undifferentiated non-keratinized carcinomas [according to the pathology of the World Health Organization]; 3. The clinical stage is t3-4n0-2m0, and T3N0 (except T3N0) (except T3N0) (appendix I); 4. Initial treatment of untreated tumor treatment; 5. There are measurable lesions or observable imaging data such as CT and MRI; 6. ECOG PS 0 or 1; 7. The expected survival time is greater than 12 months; 8. The baseline laboratory inspection meets the following criteria: Bone marrow function: WBC is greater than or equal to 4.0 x 10^9/L, and the ANC is greater than or equal to 2.0 x 10^9/ L, and PLT is greater than 100 x 10^9/L Hb is greater than 90g/L. Liver function: total bilirubin is less than or equal to ULN, AST, ALT is less than or equal to ULN x 2.5, alkaline phosphatase is less than or equal to ULN x 5; Renal function: serum creatinine (Cr) is less than or equal to ULN, and Ccr is greater than 60 ml/min (application of Cockcroft-Gault formula); Cardiac function: ecg is basically normal; 9. The patient or his legal representative voluntarily and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who are known to be allergic to chemotherapy drugs that may be used; 2. Anti-tumor treatment has been performed, including chemotherapy, radiotherapy and surgery; 3. Previous malignant tumors with other histologic sources, but treated with adequate treatment of cervical carcinoma in situ and basal cell carcinoma or squamous cell carcinoma of the skin; 4. Participated in clinical trials of any research drug in the first 4 weeks of the study; 5. In the first 4 weeks of the group, the surgery or surgical wound has not healed completely; 6. During the first four weeks of the group, the bleeding was greater than that of CTCAE 3; 7. Severe infection requires the use of antibiotics, antifungal or antiviral therapy; 8. Suffer from mental illness and have poor compliance; 9. Cases that the researchers considered inappropriate into the group. 10. Women in pregnancy or lactation;

Design outcomes

Primary

MeasureTime frame
ORR;

Secondary

MeasureTime frame
OS;PFS;DMFS;LRFS;NRFS;

Countries

China

Contacts

Public ContactHe Xia, Liu Juying

Jiangsu Cancer Hospital

hexia2003@tom.corn+86 13601458518

Outcome results

None listed

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