Two Cycles VS Three Cycles Induction Chemotherapy in T1-4N2-3 Locally Advanced Nasopharyngeal Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 2 cycles induction chemotherapy, 3 cycles induction chemotherapy.
- Who it may be relevant to
- Registry conditions: Locally Advanced Nasopharyngeal Carcinoma. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Two Cycles VS Three Cycles Induction Chemotherapy Plus Concurrent Chemoradiotherapy in T1-4N2-3 Locally Advanced Nasopharyngeal Carcinoma
Overview
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
- Drug 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). - Drug 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).
Primary outcome measures
- FFS, Failure Free Survival [Time frame: 3 years]
Eligibility criteria
Inclusion criteria
- Age 18-65 years old;
- Pathologically confirmed non-keratinizing nasopharyngeal carcinoma;
- Stage T3-4N0-1 (according to the UICC/AJCC 8th);
- No distant metastasis;
- Have not received anti-cancer treatment in the past;
- ECOG (Eastern Cooperative Oncology Group of the United States): 0-1;
- Adequate hematologic, hepatic and renal function.
Exclusion criteria
- 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;
- Combined serious illness.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- First Affiliated Hospital, Sun Yat-Sen University — Guangzhou
Identifiers
NCT: NCT05860868 · Two VS Three