RecruitingPhase 3NCT05062005

ICCRT vs. CRT for Locally Advanced Nasopharyngeal Carcinoma

Induction Chemotherapy+Chemoradiotherapy vs. Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma


Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Enrollment

447 participants

Start Date

Sep 22, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria7

  • 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 Criteria5

  • 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.

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Interventions

DRUGInduction 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.

DRUGConcurrent Chemotherapy

Cisplatin 100 mg/m², Q3w.

RADIATIONDefinitive Radiotherapy

For all patients, the prescribed dose is 66-70 Gy (once a day, 5 times a week).


Locations(1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

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NCT05062005


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