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

Taichung Veterans General Hospital

Status and phase: Unknown; Phase 3

Conditions: Nasopharyngeal Carcinoma

Treatments: Drug: Cisplatin; Drug: Leucovorin; Drug: Fluorouracil; Radiation: Radiation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02500940

CF15113A

Details and patient eligibility

About

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

Full 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

Enrollment: 54 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

Control group

Experimental group

Description:

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

Treatment:

Radiation: Radiation therapy

Drug: Fluorouracil

Drug: Cisplatin

Test group

Active Comparator group

Description:

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

Treatment:

Radiation: Radiation therapy

Drug: Leucovorin

Drug: Fluorouracil

Drug: Cisplatin