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

ConditionLocally Advanced Nasopharyngeal Carcinoma

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18-65

SponsorFirst Affiliated Hospital, Sun Yat-Sen University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-65 years old;

Pathologically confirmed non-keratinizing nasopharyngeal carcinoma;

Stage T3-4N0-1 (according to the UICC/AJCC 8th);

No distant metastasis;

Disqualifiers

The purpose of treatment is palliative;

Diagnosed with other malignant tumors at the same time;

Malignant tumor history;

Pregnancy or breastfeeding, or expect to become pregnant during the clinical trial period;

Trial design

Design model

Parallel

Treatments tested in this trial

2 cycles induction chemotherapy
Drug
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
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).

Treatment groups

474 Participants

are divided into 2 treatment groups

Group A: 2 cyclesExperimental treatment 1 intervention

Group B: 3 cyclesActive comparator 1 intervention

Trial outcomes

Primary outcomes

FFS, Failure Free Survival

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.

Time frame

3 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

First Affiliated Hospital, Sun Yat-Sen University

Lead sponsor

Source ClinicalTrials.gov

Apply now