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A Multicenter, Randomized, Phase III Clinical Trial of the GP Protocol vs TPF Protocol Induction Chemotherapy in Combination with DDP Simultaneous Chemotherapy in the Treatment of Locally Advanced Stages of Nasopharyngeal Carcinoma

A Multicenter, Randomized, Phase III Clinical Trial of the GP Protocol vs TPF Protocol Induction Chemotherapy in Combination with DDP Simultaneous Chemotherapy in the Treatment of Locally Advanced Stages of Nasopharyngeal Carcinoma

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800016613
Enrollment
Unknown
Registered
2018-06-12
Start date
2018-06-15
Completion date
Unknown
Last updated
2018-06-18

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

Conditions

Regionally advanced nasopharyngeal carcinoma

Interventions

experimental group:GP regimen and DDP regimen chemotherapy
Control group:TPF regimen and DDP regimen chemotherapy

Sponsors

The Cancer Hospital of Guizhou Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed patients who did not receive radiotherapy or chemotherapy prior to the start of the clinical trial; 2. The pathological diagnosis was non-keratoic carcinoma of the nasopharyngeal (differentiated or undifferentiated, ie WHO type II or type III); 3. III, IVa patients (AJCC Version 8 staging); 4. Male or non-pregnant women; 5. Aged 18 to 70 years old; 6. Functional status: Karnofsky scale (KPS) > 70; 7. White blood cell (WBC) = 4×10^9/L, hemoglobin (HGB) = 90 g/L, platelet (PLT) = 100×10^9/L (or within the normal range of the laboratory); 8. Liver function: ALT, aspartate transaminase (AST) = 1.5 times the upper limit of normal (ULN); total bilirubin = 1.5 x ULN; 9. Renal function: creatinine clearance = 60 ml/min or serum creatinine = 1.5 x ULN; 10. Patient has signed informed consent.

Exclusion criteria

Exclusion criteria: 1. The histological type is WHO keratinizing squamous cell carcinoma or basal squamous cell carcinoma; 2. Treatment is palliative; 3. History of previous malignant tumors, except for well-treated basal cell carcinoma or squamous cell carcinoma, and cervical carcinoma in situ; 4. Pregnancy or breastfeeding women (women of childbearing age should consider pregnancy test; emphasis on effective contraception during treatment); 5. Have previously received radiation therapy (other than non-melanoma skin cancer with previous lesions outside the target of radiotherapy); 6. Primary and cervical metastatic lesions received chemotherapy or surgery (except for diagnostic treatment); 7. Accompanied by other serious diseases, may bring greater risks or affect the compliance of the trial. Examples include unstable heart disease requiring treatment, kidney disease, chronic hepatitis, uncontrolled diabetes (fasting blood glucose >1.5 x ULN), and mental illness.

Design outcomes

Primary

MeasureTime frame
Chemotherapy-related toxicities;weight;

Countries

China

Contacts

Public ContactJin Feng

The Cancer Hospital of Guizhou Province

jinf8865@yeah.net+86 13985124806

Outcome results

None listed

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