ICCRT vs. CRT for Locally Advanced Nasopharyngeal Carcinoma

Phase 3RecruitingNCT05062005

First Affiliated Hospital, Sun Yat-Sen University447 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

447

Conditions

Locally Advanced Nasopharyngeal Carcinoma

Interventions

Induction ChemotherapyDRUG

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.

Concurrent ChemotherapyDRUG

Cisplatin 100 mg/m², Q3w.

Definitive RadiotherapyRADIATION

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

FFS (Failure-free Survival)

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.

Time frame: 3 year

Secondary Outcomes

OS (Overall Survival)

Defined as the time from randomization until death from any cause. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive. Patients remaining alive throughout the duration of the study will have their survival time censored on the date last seen alive.

Time frame: 3 year

LRFS (Locoregional Recurrence-free Survival)

Defined as the time from randomization to local or regional recurrence. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive and recurrence free. Patients not having an event will be censored at the date last seen alive.

Time frame: 3 year

DMFS (Distant Metastasis-free Survival)

Defined as the time of randomization to the appearance of distant metastasis. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive and metastasis free. Patients not having an event will be censored at the date last seen alive.

Time frame: 3 year

AE (Adverse events)

Adverse events during the treatment period will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0). Late AE of radiotherapy will be assessed according to RTOG criteria.

Time frame: 3 year

Central Contacts

Shuang Wu, PHD

CONTACT

+862087755766 wush77@mail.sysu.edu.cn

Data from ClinicalTrials.gov

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