ICCRT vs. CRT for Locally Advanced Nasopharyngeal Carcinoma

Phase 3

Recruiting

• Conditions: Locally Advanced Nasopharyngeal Carcinoma
• Interventions: Drug: Induction Chemotherapy; Radiation: Definitive Radiotherapy; Drug: Concurrent Chemotherapy

• Registration Number: NCT05062005
• 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 concurrent chemoradiotherapy is not inferior to induction chemotherapy combined with concurrent chemoradiotherapy in patients with locally advanced nasopharyngeal carcinoma.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-09-07
• Study First Submitted QC: 2021-09-21
• Last Update Submitted: 2021-09-21
• Study Start: 2021-09-22
• Study First Posted: 2021-09-30
• Last Update Posted: 2021-09-30
• Primary Completion: 2027-08-31
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 447

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chemoradiotherapy	Definitive Radiotherapy	-
Induction Chemotherapy+Chemoradiotherapy	Concurrent Chemotherapy	-
Induction Chemotherapy+Chemoradiotherapy	Definitive Radiotherapy	-
Induction Chemotherapy+Chemoradiotherapy	Induction Chemotherapy	-
Chemoradiotherapy	Concurrent Chemotherapy	-

Primary Outcome Measures

Name	Time	Method
FFS (Failure-free Survival)	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 Outcome Measures

Name	Time	Method
DMFS (Distant Metastasis-free Survival)	3 year	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.
LRFS (Locoregional Recurrence-free Survival)	3 year	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.
OS (Overall Survival)	3 year	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.
AE (Adverse events)	3 year	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.

Trial Locations

Locations (1)

The First Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guang Dong, China