Locally Advanced Nasopharyngeal Carcinoma
Conditions
Brief summary
This trial is a multi-center phase III clinical trial. The purpose of this trial is to explore whether 2 cycles induction chemotherapy combined with concurrent chemoradiotherapy is not inferior to 3 cycles induction chemotherapy combined with concurrent chemoradiotherapy in patients with locally advanced nasopharyngeal carcinoma.
Interventions
DRUG2 cycles induction chemotherapy
Drug: 2 cycles Induction Chemotherapy Induction regimens: TP (docetaxel 75 mg/m²; cisplatin 75 mg/m²) Q3w, TPF (docetaxel 60 mg/m²; cisplatin 60 mg/m²; 5-fluorouracil 600-750 mg/m² per day, continuous intravenous infusion d1-5) Q3w, or GP (gemcitabine: 1000 mg/m2 d1, d8; cisplatin 80 mg/m2) Q3w. Drug: Concurrent Chemotherapy Cisplatin 100 mg/m², Q3w. Radiation: Definitive Radiotherapy For all patients, the prescribed dose is 66-70 Gy (once a day, 5 times a week).
DRUG3 cycles induction chemotherapy
Drug: 3 cycles Induction Chemotherapy Induction regimens: TP (docetaxel 75 mg/m²; cisplatin 75 mg/m²) Q3w, TPF (docetaxel 60 mg/m²; cisplatin 60 mg/m²; 5-fluorouracil 600-750 mg/m² per day, continuous intravenous infusion d1-5) Q3w, or GP (gemcitabine: 1000 mg/m2 d1, d8; cisplatin 80 mg/m2) Q3w. Drug: Concurrent Chemotherapy Cisplatin 100 mg/m², Q3w. Radiation: Definitive Radiotherapy For all patients, the prescribed dose is 66-70 Gy (once a day, 5 times a week).
Sponsors
First Affiliated Hospital, Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-65 years old; 2. Pathologically confirmed non-keratinizing nasopharyngeal carcinoma; 3. Stage T3-4N0-1 (according to the UICC/AJCC 8th); 4. No distant metastasis; 5. Have not received anti-cancer treatment in the past; 6. ECOG (Eastern Cooperative Oncology Group of the United States): 0-1; 7. Adequate hematologic, hepatic and renal function.
Exclusion criteria
1. The purpose of treatment is palliative; 2. Diagnosed with other malignant tumors at the same time; 3. Malignant tumor history; 4. Pregnancy or breastfeeding, or expect to become pregnant during the clinical trial period; 5. Combined serious illness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FFS, Failure Free Survival | 3 years | Defined as the time from randomization to tumor recurrence, distant metastasis, or death due to any reason, whichever occurs first. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive and progression free. Patients not having an event will be censored at the date last seen alive. |
Countries
China
Contacts
Primary ContactCheng-Tao Wang
Outcome results
None listed