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

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

Study Overview

• Status: Unknown
• Conditions: Nasopharyngeal Carcinoma
• Intervention / Treatment: Drug: Cisplatin; Drug: Fluorouracil; Radiation: Radiation therapy; Drug: Leucovorin

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

• Study Type: Interventional
• Enrollment (Anticipated): 54
• Phase: Phase 3

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 40705
    • Recruiting
    • Taichung Vaterans General Hospital
    • Contact: Jin Ching Lin, Professor; Phone Number: 5613 +886 4 23592525; Email: jclin@vghtc.gov.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Control group; Neoadjuvant chemotherapy with tri-weekly cisplatin plus fluorouracil × 3 cycles (cisplatin 100 mg/m2, day 1, followed by fluorouracil 1000 mg/m2/d, days 1-4 continuous iv infusion, repeated every 3 weeks) + Intensity-Modulated Radiation Therapy ≧ 70 Gy/35 fractions	Drug: Cisplatin; Neoadjuvant chemotherapy regimen with cisplatin; Other Names: CDDP; Drug: Fluorouracil; Neoadjuvant chemotherapy regimen with Fluorouracil; Other Names: 5-FU; Radiation: Radiation therapy; Intensity-Modulated Radiation Therapy; Other Names: IMRT
Active Comparator: Test group; Neoadjuvant chemotherapy with weekly cisplatin, fluorouracil and leucovorin × 10 weeks (cisplatin 60 mg/m2 at days 1, 15, 29, 43, 57; alternatively with fluorouracil 2500 mg/m2 + leucovorin 250 mg/m2 at days 8, 22, 36, 50, 64) + Intensity-Modulated Radiation Therapy ≧ 70 Gy/35 fractions	Drug: Cisplatin; Neoadjuvant chemotherapy regimen with cisplatin; Other Names: CDDP; Drug: Fluorouracil; Neoadjuvant chemotherapy regimen with Fluorouracil; Other Names: 5-FU; Radiation: Radiation therapy; Intensity-Modulated Radiation Therapy; Other Names: IMRT; Drug: Leucovorin; Neoadjuvant chemotherapy regimen with Leucovorin; Other Names: Calcium folinate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival		5 years
Tumor response by RECIST version 1.1	According to RECIST version 1.1	5 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Taichung Veterans General Hospital
• Collaborators: Fujian Cancer Hospital
• Investigators: Study Chair: Lin Jin-Ching, Ph.D, Taichung Veterans General Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Anticipated): May 1, 2016
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: June 22, 2015
• First Submitted That Met QC Criteria: July 14, 2015
• First Posted (Estimate): July 17, 2015

Study Record Updates

• Last Update Posted (Estimate): July 17, 2015
• Last Update Submitted That Met QC Criteria: July 14, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Neoplasms; Carcinoma; Nasopharyngeal Carcinoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Protective Agents; Micronutrients; Vitamins; Antidotes; Vitamin B Complex; Cisplatin; Fluorouracil; Leucovorin
• Other Study ID Numbers: CF15113A