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

NCT05860868 | Recruiting Phase 3

• 1 other identifier: Two VS Three
• Study Type: interventional
• Target: 474
• Locations: 1 country
• Sites: 1

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.

Conditions

Locally Advanced Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 years

Study Arms (2)

2 cycles

EXPERIMENTAL

2 cycles induction + concurrent chemoradiotherapy

Drug: 2 cycles induction chemotherapy

3 cycles

ACTIVE COMPARATOR

3 cycles induction + concurrent chemoradiotherapy

Drug: 3 cycles induction chemotherapy

Interventions

2 cycles induction chemotherapy DRUG

Drug: 2 cycles 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).

2 cycles

3 cycles induction chemotherapy DRUG

Drug: 3 cycles 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).

3 cycles

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Other (Non U.s.), 510080, China

RECRUITING

Central Study Contacts

Cheng-Tao Wang

CONTACT

+862087755766; wangcht5@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: May 6, 2023
• First Posted: May 16, 2023
• Study Start: May 1, 2023
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2030
• Last Updated: May 16, 2023

Record last verified: 2023-05

Locations

CN (1)