ICCRT vs. CRT for Locally Advanced Nasopharyngeal Carcinoma

Locally Advanced Nasopharyngeal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05062005
• Other study ID #: NCICCRTvCRT
• Status: Recruiting
• Phase: Phase 3
• Start date: September 22, 2021
• Est. completion date: August 31, 2027

Study information

• Verified date: September 2021
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: Shuang Wu, PHD
• Phone: +862087755766
• Email: wush77[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 447
• Est. completion date: August 31, 2027
• Est. primary completion date: August 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Locally Advanced Nasopharyngeal Carcinoma
• Nasopharyngeal Carcinoma

Intervention

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.
• 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).

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guang Dong

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 year
Secondary	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.	3 year
Secondary	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.	3 year
Secondary	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.	3 year
Secondary	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.	3 year