Comparison the Effects of Different Neoadjuvant Chemotherapy Regimen on Acute Toxicity, Tumor Response, and Survival in Patients With Advanced Nasopharyngeal Carcinoma

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02500940

Enrollment

Registered

2015-07-17

Start date

2015-05-31

Completion date

2021-05-31

Last updated

2015-07-17

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

Conditions

Nasopharyngeal Carcinoma

Brief summary

The purpose of this study is to investigate the impact of different neoadjuvant chemotherapy schedules of cisplatin and 5-FU on acute toxicity, tumor response, and long-term survival in patients with advanced nasopharyngeal carcinoma

Detailed description

Control group: Neoadjuvant chemotherapy with tri-weekly PF × 3 cycles (cisplatin 100 mg/m2, day 1, followed by 5-FU 1000 mg/m2/d, days 1-4 continuous iv infusion, repeated every 3 weeks) + IMRT ≧ 70 Gy/35 fractions Test group: Neoadjuvant chemotherapy with weekly P-FL × 10 weeks (cisplatin 60 mg/m2 at days 1, 15, 29, 43, 57; alternatively with 5-FU 2500 mg/m2 + Leucovorin 250 mg/m2 at days 8, 22, 36, 50, 64) + IMRT ≧ 70 Gy/35 fractions

Interventions

DRUGCisplatin

Neoadjuvant chemotherapy regimen with cisplatin

DRUGFluorouracil

Neoadjuvant chemotherapy regimen with Fluorouracil

RADIATIONRadiation therapy

Intensity-Modulated Radiation Therapy

DRUGLeucovorin

Neoadjuvant chemotherapy regimen with Leucovorin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Histological proven NPC. 2. 2010 AJCC stage II-IVB. 3. Age ≧ 20 years old. 4. Performance status of ECOG ≦ 2. 5. Adequate liver, renal, and bone marrow functions 5-1 Serum total bilirubin level ≦ 2.5 mg/dl. 5-2 Serum creatinine ≦ 1.6 mg/dl or calculated CCr ≧ 60 cc/min. 5-3 WBC ≧ 3,000/ul 5-4 Platelet count ≧ 100,000/ul 6. Signed informed consent.

Exclusion criteria

1. Presence of distant metastasis. 2. Previous radiotherapy or chemotherapy. 3. History of a malignancy except those treated with curative intent for skin cancer (other than melanoma), in situ cervical cancer, ductal carcinoma in situ (DCIS) of the breast. 4. Severe cardiopulmonary diseases (unstable angina and/or congestive heart failure or peripheral vascular disease requiring hospitalization within the last 12 months; chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization) or clinically significant psychiatric disorders. 5. Female patients who are pregnant or lactating.

Design outcomes

Primary

Measure	Time frame	Description
Tumor response by RECIST version 1.1	5 years	According to RECIST version 1.1
Overall survival	5 years	—

Secondary

Measure	Time frame	Description
Acute toxicity by CTCAE deifnition	6 months	According to CTCAE deifnition

Countries

Taiwan

Contacts

Primary ContactLin Jin-Ching, Ph.D

jclin@vghtc.gov.tw+886-4-23592525

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026