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TP regimen vs TPF regimen Induction chemotherapy plus concurrent chemoradiotherapy in locoregionally advanced nasopharyngeal carcinoma: a phase 3, multicentre, randomised controlled trial

TP regimen vs TPF regimen Induction chemotherapy plus concurrent chemoradiotherapy in locoregionally advanced nasopharyngeal carcinoma: a phase 3, multicentre, randomised controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800016337
Enrollment
Unknown
Registered
2018-05-25
Start date
2018-05-28
Completion date
Unknown
Last updated
2018-05-28

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

Conditions

nasopharyngeal carcinoma

Interventions

2:TPF

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Histologically proven WHO types II-III nasopharyngeal carcinoma; 2. Stage III-IVa(except T3-4N0)(8th AJCC); 3. Initial treatment of untreated tumor treatment; 4. No history of secondary malignancy; 5. Male and femle age 18-65 years; 6. Adequate liver function: TBil=ULN; ALT and AST =2 ULN; ALP=5ULN; 7. Adequate renal function: creatinine clearance=80 mL/min; 8. Adequate bone marrow (leukocyte count =4.0×10^9/L, absolute neutrophil count =2.0×10^9/L, platelets =100×10^9/L and HB=9 g/dL); 9. No serious heart and lung dysfunction; 10. PS score = 2; 11. Patients are required to provide written informed consent before undergoing chemoradiotherapy.

Exclusion criteria

Exclusion criteria: 1. Patients with history of previous radiotherapy, chemotherapy and surgery; 2. Evidence of distant metastasis; 3. pregnancy or lactation; 4. Patients could not provide written informed consent before undergoing chemoradiotherapy; 5. Patients with poor compliance due to mental illness or poor social condition; 6. Participated in another clinical trials of any research drug; 7. Severe uncontrolled infection; 8. Major organ dysfunction, such as decompensated cardiopulmonary, kidney, liver failure, cannot tolerate surgical treatment; 9. laboratory examination: TBil=ULN; ALT and or AST =2 ULN;ALP=2.5ULN; 10. Influence on the distribution of drug delivery, metabolism and excretionsuch as mental disorder ,central nervous system abnormality, chronic diarrhea, pleural effusion; 11. Long-term use of immunosuppressive agents after organ transplantation; 12. History of other malignant tumors.

Design outcomes

Primary

MeasureTime frame
FFS;

Countries

China

Contacts

Public ContactYong Chen

Department of Radiation Oncology, The First Affiliated Hospital of Sun Yat-sen University

chenyong@mail.sysu.edu.cn+86 13826266676

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 13, 2026