Induction Chemotherapy+Chemoradiotherapy vs. Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma
Overview
- Phase
- Phase 3
- Intervention
- Induction Chemotherapy
- Conditions
- Locally Advanced Nasopharyngeal Carcinoma
- Sponsor
- First Affiliated Hospital, Sun Yat-Sen University
- Enrollment
- 447
- Locations
- 1
- Primary Endpoint
- FFS (Failure-free Survival)
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief 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.
Investigators
Chen Yong
Professor
First Affiliated Hospital, Sun Yat-Sen University
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.
Arms & Interventions
Induction Chemotherapy+Chemoradiotherapy
Intervention: Induction Chemotherapy
Induction Chemotherapy+Chemoradiotherapy
Intervention: Concurrent Chemotherapy
Induction Chemotherapy+Chemoradiotherapy
Intervention: Definitive Radiotherapy
Chemoradiotherapy
Intervention: Concurrent Chemotherapy
Chemoradiotherapy
Intervention: Definitive Radiotherapy
Outcomes
Primary Outcomes
FFS (Failure-free Survival)
Time Frame: 3 year
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.
Secondary Outcomes
- LRFS (Locoregional Recurrence-free Survival)(3 year)
- OS (Overall Survival)(3 year)
- AE (Adverse events)(3 year)
- DMFS (Distant Metastasis-free Survival)(3 year)