S-1 adjuvant chemotherapy vs watchful waiting in patients with high-risk locoregionally advanced nasopharyngeal carcinoma: a prospective, randomized, controlled, open-label phase II trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1800017583

Enrollment

Unknown

Registered

2018-08-05

Start date

2018-09-01

Completion date

Unknown

Last updated

2018-08-20

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

Conditions

nasopharyngeal carcinoma

Interventions

1:S-1 adjuvant chemotherapy

2:watchful waiting

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients are required to provide written informed consent before undergoing chemoradiotherapy; 2. Male or female aged 18-65 years; 3. PS score = 2; 4. Histologically proven WHO types II-III nasopharyngeal carcinoma; 5. Stage III-IVa(except T3-4N0 and T3N1)(8th AJCC); 6. The primary tumor is measurable; 7. Expected survival=3 months; 8. Adequate bone marrow function WBC=4.0×10^9/L, PLT=100×10^9/L and HB=100g/L; 9. Adequate liver function TBil=1.5 ULN; ALT and AST =2.5 ULN; ALP=5 ULN; 10. Adequate renal function Serum Cr<1.5×ULN, creatinine clearance=80 mL/min.

Exclusion criteria

Exclusion criteria: 1. Evidence of distant metastasis; 2. Patients with history of previous surgery, chemotherapy, radiotherapy or immunotherapy; 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. Major organ dysfunction, such as decompensated cardiopulmonary, kidney, liver failure, cannot tolerate chemoradiotherapy; 8. Influence on the distribution of drug delivery, metabolism and excretion, such as mental disorder, central nervous system abnormality, chronic diarrhea, pleural effusion; 9. Long-term use of immunosuppressive agents after organ transplantation; 10. History of other malignant tumors (except non-melanoma skin cancer or cervical carcinoma in situ).

Design outcomes

Primary

Measure	Time frame
Progression-Free Survival;	—

Secondary

Measure	Time frame
Overall Survival;Distant Metastasis-Free Survival;Locoregional Relapse-Free Survival;Safety;Adverse Events;	—

Countries

China

Contacts

Public ContactTai-ze Yuan

Department of Radiotherapy, Affiliated Cancer Hospital of Guangzhou Medical University

yuantaize@gzhmu.edu.cn+86 13512786950

Outcome results

None listed

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