Two Cycles VS Three Cycles Induction Chemotherapy in T1-4N2-3 Locally Advanced Nasopharyngeal Carcinoma

NCT05860868 · tracked via the Priya Life Science China tracker

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Phase

Phase 3

Started

2023-05

Last updated

2023-05-16

Condition(s) studied

Locally Advanced Nasopharyngeal Carcinoma

Investigational drug(s) / intervention(s)

2 cycles induction chemotherapy3 cycles induction chemotherapy

2 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).

3 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).

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

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.

Primary outcome measure(s)

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.

Trial sites (1)

Facility	City	Region	Status
First Affiliated Hospital, Sun Yat-Sen University	Guangzhou	Other (Non U.s.)	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05860868 on ClinicalTrials.gov ↗ ← All trials in China