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

Nasopharyngeal Carcinoma Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02500940
• Other study ID #: CF15113A
• Status: Recruiting
• Phase: Phase 3
• First received: June 22, 2015
• Last updated: July 14, 2015
• Start date: May 2015
• Est. completion date: May 2021

Study information

• Verified date: July 2015
• Source: Taichung Veterans General Hospital
• Contact: Lin Jin-Ching, Ph.D
• Phone: +886-4-23592525
• Email: jclin[@]vghtc.gov.tw
• Is FDA regulated: No
• Health authority: Taiwan:Nation Health Research Institutes
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: May 2021
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms

Intervention

Drug:
• Cisplatin
Neoadjuvant chemotherapy regimen with cisplatin
• Fluorouracil
Neoadjuvant chemotherapy regimen with Fluorouracil

Radiation:
• Radiation therapy
Intensity-Modulated Radiation Therapy

Drug:
• Leucovorin
Neoadjuvant chemotherapy regimen with Leucovorin

Locations

Country	Name	City	State
Taiwan	Taichung Vaterans General Hospital	Taichung

Sponsors (2)

Lead Sponsor	Collaborator
Taichung Veterans General Hospital	Fujian Cancer Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor response by RECIST version 1.1	According to RECIST version 1.1	5 years	No
Primary	Overall survival		5 years	No
Secondary	Acute toxicity by CTCAE deifnition	According to CTCAE deifnition	6 months	Yes