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

Phase 3

Recruiting

• Conditions: Locally Advanced Nasopharyngeal Carcinoma
• Interventions: Drug: 2 cycles induction chemotherapy; Drug: 3 cycles induction chemotherapy

• Registration Number: NCT05860868
• Lead Sponsor: First Affiliated Hospital, Sun Yat-Sen University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-05
• Study Start: 2023-05
• Study First Submitted: 2023-05-06
• Study First Submitted QC: 2023-05-06
• Last Update Submitted: 2023-05-06
• Study First Posted: 2023-05-16
• Last Update Posted: 2023-05-16
• Primary Completion: 2028-05
• Study Completion: 2030-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 474

Inclusion Criteria

1. Age 18-65 years old;
2. Pathologically confirmed non-keratinizing nasopharyngeal carcinoma;
3. Stage T3-4N0-1 (according to the UICC/AJCC 8th);
4. No distant metastasis;
5. Have not received anti-cancer treatment in the past;
6. ECOG (Eastern Cooperative Oncology Group of the United States): 0-1;
7. Adequate hematologic, hepatic and renal function.

Exclusion Criteria

1. The purpose of treatment is palliative;
2. Diagnosed with other malignant tumors at the same time;
3. Malignant tumor history;
4. Pregnancy or breastfeeding, or expect to become pregnant during the clinical trial period;
5. Combined serious illness.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2 cycles	2 cycles induction chemotherapy	2 cycles induction + concurrent chemoradiotherapy
3 cycles	3 cycles induction chemotherapy	3 cycles induction + concurrent chemoradiotherapy

Primary Outcome Measures

Name	Time	Method
FFS, Failure Free Survival	3 years	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.

Trial Locations

Locations (1)

First Affiliated Hospital, Sun Yat-Sen University; 🇨🇳 Guangzhou, Other (Non U.s.), China