Induction chemotherapy with GP versus TPF in III-IVA nasopharyngeal carcinoma: a randomized controlled trial

Induction chemotherapy with Gemcitabine plus cisplatin versus docetaxel, cisplatin and fluorouracil in III-IVA nasopharyngeal carcinoma: a non-inferiority, randomized phase 3 trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900022288

Enrollment

Unknown

Registered

2019-04-03

Start date

2020-08-01

Completion date

Unknown

Last updated

2019-04-08

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

Conditions

nasopharyngeal carcinoma

Interventions

experimental group:gemcitabine + cisplatin

control group:docetaxel + cisplatin + fluorouracil

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. In the newly diagnosed patient. 2. Pathologically confirmed as non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated, ie WHO type II or III). 3. III, IVA patients (AJCC version 8 staging, except T3N0 and T4N0). 4. Aged = 18 and 70. 6. White blood cells (WBC) = 4 × 10^9/L, hemoglobin (HGB) = 90 g / L, platelets (PLT) = 100 × 10^9 / L (or within the normal range of the laboratory). 7. Liver function: alanine aminotransferase (ALT), aspartate aminotransferase (AST) = 1.5 times the upper limit of normal (ULN); Total bilirubin = 1.5 × ULN. 8. Renal function: creatinine clearance = 60ml / min or serum creatinine = 1.5 × ULN. 9. The patient has signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Treatment is palliative. 2. Previous history of malignant tumors, well-treated basal cell carcinoma or squamous cell carcinoma and cervical carcinoma in situ outer. 3. Women during pregnancy or lactation (pregnant women should be considered for women of childbearing age; Effective contraception). 4. Previously received chemotherapy or radiation therapy (if non-melanoma skin cancer and previous lesions are outside the target area of radiotherapy, then except). 5. Primary and cervical metastatic lesions received chemotherapy or surgery (except for diagnostic treatment). 6. With other serious diseases, it may bring greater risk or affect the compliance of the test. For example: no need for treatment Stable heart disease, kidney disease, chronic hepatitis, control of unsatisfactory diabetes (fasting blood glucose > 1.5 × ULN), and mental illness.

Design outcomes

Primary

Measure	Time frame
3-year failure free survival(FFS);	—

Secondary

Measure	Time frame
3-year overall survival(OS);3-year Distant metastasis-free survival (DMFS);3-year Locoregional failure-free survival(LRFS);cost-effectiveness;quality of life;toxicity;	—

Countries

China

Contacts

Public ContactNianyong Chen

West China Hospital, Sichuan University

n_ychen@hotmail.com+86 18980602053

Outcome results

None listed

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