ICCRT vs. CRT for Locally Advanced Nasopharyngeal Carcinoma

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

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 Overview

• Status: Recruiting
• Conditions: Locally Advanced Nasopharyngeal Carcinoma
• Intervention / Treatment: Drug: Induction Chemotherapy; Drug: Concurrent Chemotherapy; Radiation: Definitive Radiotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 447
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Shuang Wu, PHD; Phone Number: +862087755766; Email: wush77@mail.sysu.edu.cn

Study Locations

• China
  • Guang Dong
    • Guangzhou, Guang Dong, China, 510080
      • Recruiting
      • The First Affiliated Hospital of Sun Yat-sen University
      • Contact: Shuang Wu, PHD; Phone Number: +862087755766; Email: wush77@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Induction Chemotherapy+Chemoradiotherapy	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.; Drug: 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).
Other: Chemoradiotherapy	Drug: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital, Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 22, 2021
• Primary Completion (Anticipated): August 31, 2027
• Study Completion (Anticipated): August 31, 2027

Study Registration Dates

• First Submitted: September 7, 2021
• First Submitted That Met QC Criteria: September 21, 2021
• First Posted (Actual): September 30, 2021

Study Record Updates

• Last Update Posted (Actual): September 30, 2021
• Last Update Submitted That Met QC Criteria: September 21, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Neoplasms; Carcinoma; Nasopharyngeal Carcinoma
• Other Study ID Numbers: NCICCRTvCRT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No