ICCRT vs. CRT for 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: Induction Chemotherapy, Concurrent Chemotherapy, Definitive Radiotherapy.
- 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 →
Unsure about the terms? Read our patient guide →
Official title
Induction Chemotherapy+Chemoradiotherapy vs. Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma
Overview
This trial is a multi-center phase III clinical trial. The purpose of this trial is to explore whether concurrent chemoradiotherapy is not inferior to induction chemotherapy combined with concurrent chemoradiotherapy in patients with locally advanced nasopharyngeal carcinoma.
Interventions
- Drug 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 year]
Secondary outcome measures (4)
- OS (Overall Survival) [Time frame: 3 year]
- LRFS (Locoregional Recurrence-free Survival) [Time frame: 3 year]
- DMFS (Distant Metastasis-free Survival) [Time frame: 3 year]
- AE (Adverse events) [Time frame: 3 year]
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
- The First Affiliated Hospital of Sun Yat-sen University — Guangzhou
Identifiers
NCT: NCT05062005 · NCICCRTvCRT